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CYCN

CYCN US Stock
$2.53
Open: $2.56 High: $2.654 Low: $2.31 Close: $2.53
Range: 2021-05-06 - 2021-05-07
Volume: 547,816
Market: Closed
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CYCN
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CYCN News
Latest news about the CYCN
  • Cyclerion Therapeutics Hosted Webinar to Discuss Pipeline Progress

    Provided updates on development strategy and execution for CY6463, a first-in-class, CNS-penetrant sGC stimulator, including IND clearance from FDA in ADv and ongoing MELAS program Introduced new CY6463 clinical program in CIAS with key insights from neuropsychiatric key opinion leader, Andreas Reif, M.D. Announced new development candidate, CY3018, a differentiated, next-generation CNS-penetrant sGC stimulator CAMBRIDGE, Mass., April 27, 2021 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function, hosted a webinar today to provide clinical updates for its first-in-class, CNS-penetrant soluble guanylate cyclase (sGC) stimulator CY6463 in Alzheimer's Disease with Vascular pathology (ADv) and Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS). Supported by recent clinical and preclinical data, Cyclerion also discussed the potential for CY6463 to treat Cognitive Impairment Associated with Schizophrenia (CIAS), with key insights from Dr. Andreas Reif on the role of the sGC pathway in the disease. In addition, Cyclerion introduced its latest development candidate CY3018, a differentiated, next-generation, CNS-penetrant sGC stimulator. “To deliver on our mission to develop treatments that restore cognitive function, we are harnessing the momentum and insights from our preclinical and clinical data on the fundamental role of the NO-sGC-cGMP pathway in central nervous system diseases,” said Peter Hecht, Ph.D., Chief Executive Officer of Cyclerion. “Following the science, we see the potential to unlock significant opportunities across a number of patient populations with cognitive impairment, who are in desperate need of new therapeutic options.” Key Webinar Highlights Modulating a fundamental CNS signaling pathway: sGC stimulators amplify the power of the nitric oxide‐soluble guanylate cyclase‐cyclic guanosine monophosphate pathway (NO-sGC-cGMP) signaling to address central aspects of disease pathophysiology. Preclinical data from CY6463 and extensive academic work validate the crucial role of the sGC pathway in brain physiology. Clinical data from the recent translational pharmacology study confirm the ability of CY6463 to impact brain oscillations, neuroinflammation and neurophysiological function. CY6463 Updates Disease-relevant, biomarker-guided pipeline strategy: The company is advancing parallel, signal-seeking, exploratory studies in well-defined patient populations with cognitive impairment including neurodegenerative, neuropsychiatric, and mitochondrial diseases. CY6463 targets sGC, a proven druggable target, in critical brain regions and cell types linked to cognition and has demonstrated an impact on multiple biomarkers associated with cognition in previous Phase 1 studies.ADv clinical trial initiation: The U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application for CY6463 in ADv, and the Company anticipates beginning to enroll patients in a 12-week Phase 2a clinical trial in patients with ADv by mid-2021, barring any COVID-19 related delays. This exploratory study is designed to evaluate safety, tolerability, and pharmacodynamic effects including impact on disease-relevant biomarkers.MELAS clinical trial advancement: This study is enrolling more slowly than initially projected, primarily due to COVID-19. Data from the exploratory 29-day open-label Phase 2a pilot study in patients with MELAS are now expected by year end 2021. Potential to treat CIAS with novel mechanism: Neuropsychiatric key opinion leader and expert in the neurobiology of nitric oxide and its relation to psychiatric disorders, Andreas Reif, M.D., Chair, Department of Psychiatry, University Hospital Frankfurt, discussed the sGC pathway and its role in cognitive function and CIAS. Reduced NO-sGC-cGMP signaling is linked to cognitive dysfunction in schizophrenia. Stimulation of sGC by CY6463 to amplify NO-sGC-cGMP signaling is a potential first-in-class approach for the treatment of CIAS. Cyclerion is planning to initiate a Phase 1b signal-seeking study in CIAS to evaluate safety and near-term impact on disease-relevant biomarkers. CY3018, a differentiated, next-generation CNS-penetrant sGC stimulator: Cyclerion shared information on the latest development candidate, CY3018. Preclinical data show increased CNS-exposure, with significantly increased cerebrospinal fluid (CSF) to plasma ratio, compared to CY6463. This increased CNS distribution is mirrored by a higher level of pharmacological activity in the CNS relative to the periphery. The company is advancing CY3018 through IND-enabling development. “We are using insights from our preclinical and clinical data to tap into a fundamental CNS signaling pathway with CY6463 – our first-in-class, CNS-penetrant sGC stimulator,” said Andy Busch, Ph.D., Chief Scientific Officer at Cyclerion. “We are excited by the data from our CY6463 translational pharmacology study that demonstrated rapid improvement in biomarkers associated with cognition and reflect CY6463’s multidimensional pharmacology. These data are leading us to explore opportunities in cognition through the sGC pathway.” Cash, cash equivalents, and restricted cash balance on March 31, 2021 was approximately $45 million, as compared to approximately $58 million on December 31, 2021. As of April 2021, Cyclerion has substantially streamlined its operating model to invest more fully in its priority opportunities in cognition and expects average monthly cash use for the foreseeable future to be approximately 50 percent that of 2020. Webinar Replay Information A replay of the event can be accessed by visiting the investors' section of the Cyclerion website at https://ir.cyclerion.com/news-events/event-calendar. About Cyclerion Therapeutics Cyclerion Therapeutics is a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function. Cyclerion’ is advancing novel, first-in-class, CNS-penetrant, sGC stimulators that modulate a key node in a fundamental CNS signaling pathway. The multidimensional pharmacology elicited by the stimulation of sGC has the potential to impact a broad range of CNS diseases. The most advanced compound, CY6463 has shown rapid improvement in biomarkers associated with cognitive function and is currently in clinical development for Alzheimer's Disease with Vascular pathology (ADv) and Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS) and Cognitive Impairment Associated with Schizophrenia (CIAS). Cyclerion is also advancing CY3018, a next generation sGC stimulator. For more information about Cyclerion, please visit https://www.cyclerion.com/ and follow us on Twitter (@Cyclerion) and LinkedIn (www.linkedin.com/company/cyclerion). Forward Looking StatementThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties, including statements about the anticipated timing of release of topline results of our clinical trials; the progression of our discovery programs into clinical development; and the business and operations of the Company. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include those related to the possibility that any results of operations and financial condition of the Company reported are preliminary and subject to final audit and the risks listed under the heading “Risk Factors” and elsewhere in our 2020 Form 10-K filed on February 25, 2021, and our subsequent SEC filings. Investors are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and Cyclerion undertakes no obligation to update these forward-looking statements, except as required by law. InvestorsCarlo Tanzi, Ph.D.Kendall Investor Relationsctanzi@kendallir.com MediaAmanda SellersVerge Scientific Communicationsasellers@vergescientific.com

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  • Cyclerion Therapeutics Appoints Errol De Souza, Ph.D., to Board of Directors

    Senior CNS expert and biotech business leader to inform strategy and future clinical developmentCAMBRIDGE, Mass., April 26, 2021 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function, announced today the appointment of Errol De Souza, Ph.D., to its board of directors. Dr. De Souza is a seasoned R&D and business leader with broad experience - from large pharma to start ups - in the discovery and development of therapeutics for the treatment of central nervous system (CNS) disorders. Dr. De Souza is currently the executive chairman of Bionomics Limited and a member of the board of directors of Royalty Pharma and Catalyst Biosciences. Previously, Dr. De Souza founded Neurocrine Biosciences, Inc., served as CEO of numerous publicly traded and private companies, including Biodel, Inc., Synaptic Pharmaceutical Corp., Archemix Corp. and Neuropore Therapies, Inc. In addition, he led CNS R&D at DuPont Merck and US R&D at Aventis. Dr. De Souza received a B.A. in physiology and a Ph.D. in endocrinology from the University of Toronto. "We are excited to welcome Errol to the Cyclerion Board of Directors. With deep expertise in CNS drug development and strategic business experience at the highest levels of biotech leadership, Errol will provide important counsel to help shape the future of Cyclerion," said Peter Hecht, Ph.D. chief executive officer of Cyclerion. “We seek board members with strong strategic judgment, an owner-oriented mindset, business savvy, a strong interest in our company, and absolute integrity, and Errol embodies all of those attributes and will serve as an outstanding representative of our shareholders and advisor to our company.” "I have great respect for the Cyclerion team's drug-making expertise and the potential for modulation of the NO-sGC-cGMP pathway to positively impact brain physiology," said Dr. De Souza. "I look forward to joining Cyclerion's highly-committed board at this pivotal time to provide guidance on the company's strategy and support the mission of creating therapies that restore cognitive function for patients." About Cyclerion Therapeutics Cyclerion Therapeutics is a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function. Cyclerion’s lead molecule is CY6463, a novel, first-in-class, CNS-penetrant, sGC stimulator that modulates a key node in a fundamental CNS signaling network. The multidimensional pharmacology elicited by the stimulation of sGC has the potential to impact a broad range of CNS diseases. CY6463 has shown rapid improvement in biomarkers associated with cognitive function and is currently in clinical development for Alzheimer's Disease with Vascular pathology (ADv) and Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS). For more information about Cyclerion, please visit https://www.cyclerion.com/ and follow us on Twitter (@Cyclerion) and LinkedIn (www.linkedin.com/company/cyclerion). Forward Looking StatementThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the risks listed under the heading “Risk Factors” and elsewhere in our 2020 Form 10-K filed on February 25, 2021. Investors are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and Cyclerion undertakes no obligation to update these forward-looking statements, except as required by law. InvestorsCarlo Tanzi, Ph.D.Kendall Investor Relationsctanzi@kendallir.com MediaAmanda SellersVerge Scientific Communicationsasellers@vergescientific.com

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  • Cyclerion Therapeutics to Participate in the B. Riley Neuroscience Investor Conference

    CAMBRIDGE, Mass., April 21, 2021 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function, today announced that Cheryl Gault, Chief Operating Officer will present a corporate overview at B. Riley’s Neuroscience Investor Conference on Thursday, April 29, 2021 at 1:00 p.m. ET. Cyclerion leaders will also be available for one-on-one meetings at this conference and investors may request a one-on-one meeting through B. Riley. The live webcast can be accessed via the Investors & Media section of the Cyclerion website at https://ir.cyclerion.com/news-events/event-calendar. An archived replay of the event will be available on the site for approximately 90 days following the presentation. About Cyclerion Therapeutics Cyclerion Therapeutics is a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function. Cyclerion’s lead molecule is CY6463, a novel, first-in-class, CNS-penetrant, sGC stimulator that modulates a key node in a fundamental CNS signaling network. The multidimensional pharmacology elicited by the stimulation of sGC has the potential to impact a broad range of CNS diseases. CY6463 has shown rapid improvement in biomarkers associated with cognitive function and is currently in clinical development for Alzheimer's Disease with Vascular pathology (ADv) and Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS). For more information about Cyclerion, please visit https://www.cyclerion.com/ and follow us on Twitter (@Cyclerion) and LinkedIn (www.linkedin.com/company/cyclerion). InvestorsCarlo Tanzi, Ph.D.Kendall Investor Relationsctanzi@kendallir.com MediaAmanda SellersVerge Scientific Communicationsasellers@vergescientific.com

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  • Cyclerion Therapeutics to Host Pipeline Update Webinar

    Company to discuss clinical updates for CY6463, including Phase 2a studies in ADv and MELAS, and plans to initiate Phase 1b clinical trial in CIAS Neuropsychiatric key opinion leader, Andreas Reif, M.D. to discuss role of sGC pathway in CIAS Webcast scheduled for Tuesday, April 27th from 8 – 9 a.m. EDT CAMBRIDGE, Mass., April 20, 2021 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function, will host a webinar on Tuesday, April 27th at 8 a.m. EDT with a live Q&A. The Company will provide a corporate update on clinical programs for its first-in-class CNS penetrant soluble guanylate cyclase (sGC) stimulator, CY6463, in Alzheimer's Disease with Vascular pathology (ADv) and Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS). Supported by recent clinical and preclinical data, Cyclerion will discuss the potential for CY6463 to treat Cognitive Impairment Associated with Schizophrenia (CIAS). In addition, neuropsychiatric key opinion leader, Andreas Reif, M.D., Chair, Department of Psychiatry, University Hospital Frankfurt, will discuss the sGC pathway, its role in cognitive function and CIAS. Dr. Reif is the author of more than 400 scientific publications and has conducted extensive research in the mechanisms of nitric oxide synthase and applications to the clinic, particularly in psychiatry. Cyclerion will also introduce its latest development candidate CY3018, a differentiated, next-generation CNS-penetrant sGC stimulator. “At Cyclerion, we are forging new paths to identify novel therapies for patients with cognitive impairment,” said Peter Hecht, Ph.D., Chief Executive Officer of Cyclerion. “We look forward to sharing more details about the sGC pathway and its role in cognition, our current clinical programs, and the expansion of our pipeline with the collective goal of restoring cognitive function.” Webcast Information To register for the webinar, please click here. The live event can be accessed by visiting the investors' section of the Cyclerion website at https://ir.cyclerion.com/news-events/event-calendar. An archived replay will also be available on the company website. About Cyclerion Therapeutics Cyclerion Therapeutics is a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function. Cyclerion’s lead molecule is CY6463, a novel, first-in-class, CNS-penetrant, sGC stimulator that modulates a key node in a fundamental CNS signaling network. The multidimensional pharmacology elicited by the stimulation of sGC has the potential to impact a broad range of CNS diseases. CY6463 has shown rapid improvement in biomarkers associated with cognitive function and is currently in clinical development for Alzheimer's Disease with Vascular pathology (ADv) and Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS) and Cognitive Impairment Associated with Schizophrenia (CIAS). Cyclerion is also advancing CY3018, a next generation sGC stimulator. For more information about Cyclerion, please visit https://www.cyclerion.com/ and follow us on Twitter (@Cyclerion) and LinkedIn (www.linkedin.com/company/cyclerion). Forward Looking StatementThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the risks listed under the heading “Risk Factors” and elsewhere in our 2020 Form 10-K filed on February 25, 2021. Investors are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and Cyclerion undertakes no obligation to update these forward-looking statements, except as required by law. InvestorsCarlo Tanzi, Ph.D.Kendall Investor Relationsctanzi@kendallir.com MediaAmanda SellersVerge Scientific Communicationsasellers@vergescientific.com

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  • TransMedics Appoints Stephanie Lovell to Board of Directors

    TransMedics Group, Inc. ("TransMedics") (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, announced today the appointment of Stephanie Lovell to its Board of Directors and as a member of the Nominating and Corporate Governance Committee, effective March 22, 2021.

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  • Are Institutions Heavily Invested In Cyclerion Therapeutics, Inc.'s (NASDAQ:CYCN) Shares?

    A look at the shareholders of Cyclerion Therapeutics, Inc. ( NASDAQ:CYCN ) can tell us which group is most powerful...

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  • The Daily Biotech Pulse: Sarepta Gene Therapy Data, Idera Plunges On Failed Skin Cancer Study, 3 IPOs

    Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech Stocks Hitting 52-week Highs March 18) AngioDynamics, Inc. (NASDAQ: ANGO) Anixa Biosciences, Inc. (NASDAQ: ANIX) ENDRA Life Sciences Inc. (NASDAQ: NDRA) (announced a collaboration with Hepion Pharmaceuticals, Inc. (NASDAQ: HEPA) for NASH studies) Harvard Bioscience, Inc. (NASDAQ: HBIO) Neos Therapeutics, Inc. (NASDAQ: NEOS) (reacted to the shareholder meeting held to vote on the proposal to merge with Aytu BioScience, Inc. (NASDAQ: AYTU)) NuVasive, Inc. (NASDAQ: NUVA) SI-BONE, Inc. (NASDAQ: SIBN) Sierra Oncology, Inc. (NASDAQ: SRRA) Silverback Therapeutics, Inc. (NASDAQ: SBTX) Terns Pharmaceuticals, Inc. (NASDAQ: TERN) Varian Medical Systems, Inc. (NASDAQ: VAR) Vericel Corporation (NASDAQ: VCEL) Vincerx Pharma, Inc. (NASDAQ: VINC) Down In The Dumps (Biotech Stocks Hitting 52-week Lows March 18) Foghorn Therapeutics Inc. (NASDAQ: FHTX) (issued a corporate update) Galecto, Inc. (NASDAQ: GLTO) Voyager Therapeutics, Inc. (NASDAQ: VYGR) Stocks In Focus Sarepta Presents Positive Data For Gene Therapy to Treat Limb-gridle Muscular Dystrophy Sarepta Therapeutics, Inc. (NASDAQ: SRPT) announced new results from the ongoing study of SRP-9003, its investigational gene therapy for limb-girdle muscular dystrophy Type 2E, showing sustained protein expression in muscle tissue. Functional assessments taken two years following treatment in low-dose arm and one year after treatment in high-dose arm showed that patients continued to demonstrate stability in their NSAD total score and improvements on timed function tests. Results in both cohorts continue to reinforce the safety and tolerability profile of SRP-9003, the company said. The results were presented today at the 2021 Muscular Dystrophy Association Annual Clinical and Scientific Conference. In after-hours trading, the stock added 4.75% to $87.75. Cyclerion Announces Departure of Chief Medical Officer Cyclerion Therapeutics, Inc. (NASDAQ: CYCN) said Christopher Wright, its chief medical officer, has resigned his position with the company. Wright will provide Cyclerion with transitional support until March 26, and will also join the company's Clinical Advisory Board. vTv Commences Study to Evaluate Potential of TTP399 In Reducing Ketoacidosis In Type 1 Diabetes Patients vTv Therapeutics Inc. (NASDAQ: VTVT) announced the initiation of a mechanistic study exploring the effects of TTP399 on ketone body formation during a period of insulin withdrawal in people with type 1 diabetes. The phase 1 study, the company said, will test the hypothesis that treatment with vTv's TTP399 will not result in the increased production of ketones, a precursor to ketoacidosis, which can lead to hospitalization in patients with type 1 diabetes. Diabetic ketoacidosis is a serious complication of diabetes that occurs when the body produces high levels of blood acids called ketones when insulin production by the body is inadequate. The stock lost 3.91% to $2.70 in after-hours trading. Incyte's Jakafi Flunks a Late-stage Study In Treating ARDS In COVID-19 Patients Incyte Corporation (NASDAD: INCY) said the Phase 3 DEVENT study evaluating the efficacy and safety of Jakafi, 5mg and 16mg doses, plus standard-of-care versus SoC in patients on mechanical ventilation with COVID-19 associated Acute Respiratory Distress Syndrome did not meet its primary endpoint. Improvement in mortality for each dose compared to placebo, while trending toward positive, was not statistically significant for the overall study population, the company said. However, significant improvement in mortality was seen in U.S. study participants at both doses, and in the overall population when data from both treatment arms was pooled. The company said it will discuss with the FDA regarding an expanded access program to allow eligible patients in the U.S. with COVID-19-associated ARDS to receive ruxolitinib. In after-hours trading, the stock rose 1.06% to $79.08 in after-hours trading. Idera Says Lead Drugs Flunks Late-Stage Skin Cancer Study Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) said the ILLUMINATE-301 pivotal registration trial of its lead product candidate tilsotolimod in combination with Bristol-Myers Squibb Company's (NYSE: BMY) Yervoy versus ipilimumab alone in patients with anti-PD-1 refractory advanced melanoma, did not meet its primary endpoint of objective response rate. Idera said it is evaluating its next steps regarding continuation of the trial toward its overall survival endpoint, which includes evaluating the full data set when it is available. The company also plans to continue its ILLUMINATE-206 Phase 2 study of tilsotolimod in combination with ipilimumab and nivolumab in patients with microsatellite stable colorectal cancer. View more earnings on IBB The stock plunged 59.88% to $2.01 in after-hours trading. Merck, Eisai Report Positive Late-Stage Data For Combo Therapy In Endometrial Cancer Merck (NYSE: MRK) and Eisai Co., Ltd. (OTC: ESALY) announced positive data from the pivotal Phase 3 KEYNOTE-775/Study 309 trial that evaluated the combination of the former's Keytruda plus the latter's Lenvima, for the treatment of certain patients with advanced, metastatic or recurrent endometrial cancer following one prior platinum-based regimen in any setting. The data was presented in an oral plenary session at the virtual Society of Gynecologic Oncology 2021 Annual Meeting on Women's Cancer. Kiniksa Announces FDA Approval for Arcalyst In Treating Autoinflammatory Cardiovascular Disease Kiniksa Pharmaceuticals, Ltd. (NASDAQ: KNSA) said the FDA approved Arcalyst, a weekly, subcutaneously-injected, recombinant fusion protein, for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and children 12 years and older. The company expects to launch the drug in April 2021. The stock gained 10.50% to $24 in after-hours trading. Marker Therapeutics Gains On Insider Buying Marker Therapeutics, Inc. (NASDAQ: MRKR) shares moved to the upside after a series of filings by the company revealed company insiders bought shares in the company. The stock was up 21.11% to $2.18 in after-hours trading. Earnings Alpine Immune Sciences, Inc. (NASDAQ: ALPN) reported an increase in its fourth-quarter revenues from $884,000 in 2019 to $5.64 million in 2020. The net loss per share narrowed from 33 cents to 27 cents. The stock slipped 5.87% to $13 in after-hours trading. On The Radar Clinical Readouts The Society of Gynecologic Oncology Meeting Presentations Aravive, Inc. (NASDAQ: ARAV): Updated data from the Phase 1b trial evaluating AVB-500 in platinum resistant ovarian cancer (3:35 pm); Additionally, a trial in progress poster is to be presented on the Phase 1/2 investigator-sponsored trial of AVB-500 in combination with durvalumab in patients with platinum resistant, recurrent epithelial ovarian cancer. Leap Therapeutics, Inc. (NASDAQ: LPTX): Additional data from the Phase 2 study of DKN-01 and Paclitaxel chemotherapy medication in endometrial cancer Earnings Celsion Corporation (NASDAQ: CLSN) IPOs Finch Therapeutics Group, Inc, a clinical-stage microbiome therapeutics company developing a novel class of orally administered biological drugs, priced its upsized initial public offering of 7.5 million shares of common stock at $17 per share, for raising gross proceeds of $127.5 million. The shares will begin trading on the Nasdaq under the ticker symbol FNCH. China-based biopharma Connect Biopharma Holdings Ltd priced its IPO of 11.25 million ADSs, representing 11.25 million ordinary shares of the company, at $17 per ADS. The gross proceeds from the offering are expected to be $191.3 million. The ADSs of the company that is developing T-cell therapies for chronic inflammatory diseases will begin trading on the Nasdaq under the ticker symbol CNTB. Instil Bio, Inc., a clinical-stage biopharmaceutical company that develops an innovative cell therapy pipeline of autologous TIL therapies for the treatment of patients with cancer, priced its upsized initial public offering of 16 million shares of common stock at $20 per share. The gross proceeds of the offering, are expected to be $320 million. The shares are expected to begin trading on the Nasdaq under the symbol TIL. Related Link: Attention Biotech Investors: Mark Your Calendar For March PDUFA Dates See more from BenzingaClick here for options trades from BenzingaThe Daily Biotech Pulse: Translate Bio's Cystic Fibrosis Study Disappoints, Adverum Nominates Directors, Gain Therapeutics To Debut On NasdaqThe Daily Biotech Pulse: Merck's Keytruda Gets Label Expansion In Europe, Pfizer To Sell Chinese Biologics Unit, Celcuity Spikes© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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  • Cyclerion Therapeutics Announces Departure of Chief Medical Officer

    CAMBRIDGE, Mass., March 18, 2021 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function, today announced that Christopher Wright, M.D., Ph.D., Chief Medical Officer, has resigned his position with the company. He will provide Cyclerion with transitional support until March 26, 2021 and will join the Company’s Clinical Advisory Board. “Chris has played an important role in advancing our clinical efforts, and we are pleased to have him join our Clinical Advisory Board. We wish Chris the very best in his future endeavors,” said Peter Hecht, Ph.D., Chief Executive Officer of Cyclerion. About Cyclerion Therapeutics Cyclerion Therapeutics is a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function. Cyclerion’s lead program is CY6463, a novel, first-in-class, CNS-penetrant, sGC stimulator that modulates a key node in a fundamental CNS signaling network. The multidimensional pharmacology elicited by the stimulation of sGC has the potential to impact a broad range of CNS diseases. CY6463 has shown rapid improvement in biomarkers associated with cognitive impairment and is currently in clinical development for Alzheimer's Disease with Vascular pathology (ADv) and Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS). For more information about Cyclerion, please visit https://www.cyclerion.com/ and follow us on Twitter (@Cyclerion) and LinkedIn (www.linkedin.com/company/cyclerion). Forward Looking StatementThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the risks listed under the heading “Risk Factors” and elsewhere in our 2020 Form 10-K filed on February 25, 2021. Investors are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and Cyclerion undertakes no obligation to update these forward-looking statements, except as required by law. InvestorsCarlo Tanzi, Ph.D.Kendall Investor Relationsctanzi@kendallir.com MediaAmanda SellersVerge Scientific Communicationsasellers@vergescientific.com

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  • Cyclerion Therapeutics Reports Full Year 2020 Financial Results and Corporate Update

    Novel mechanism of CY6463 demonstrated desired blood brain barrier penetration, target engagement, favorable safety and tolerability profile as well as evidence in multiple independent biomarkers associated with cognitive impairment, including neuroinflammatory biomarkers; MELAS Phase 2a study underway with top-line data anticipated in mid-2021; Phase 2a study Alzheimer’s disease with vascular pathology expected to initiate in mid-2021; Transformation to a nimble and efficient CNS organization with leading clinical and scientific advisory boards to accelerate novel approaches to restore cognitive function for patients CAMBRIDGE, Mass., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function, today reported financial results for the full year 2020 and provided general corporate and pipeline updates. “The highly encouraging clinical data from our lead asset, CY6463, is guiding our clinical strategy and we expect 2021 to be an exciting year as we begin to explore the impact of modulating a key node in a fundamental CNS signaling network in patients,” said Peter Hecht, Ph.D., Chief Executive Officer of Cyclerion. “This positive momentum in the clinic includes the initiation of clinical studies in patients with Alzheimer’s disease with vascular pathology (ADv) and Mitochondrial Encephalopathy, Lactic Acidosis, and Stroke-like episodes (MELAS). Given the broad potential associated with this novel mechanism in the CNS for a range of patients, we will continue to assess additional indication opportunities for CY6463 and differentiated molecules to deliver the full potential of our pipeline.” Recent Program and Business Updates CY6463 Program Updates: Cyclerion announced promising results from its Phase 1 translational pharmacology study of CY6463, the first soluble guanylate cyclase (sGC) stimulator in clinical development for CNS disorders.Treatment with CY6463 in the 15-day, 24-subject crossover study confirmed and extended results seen in the earlier Phase 1 study: once daily oral treatment demonstrated blood-brain-barrier penetration, desired CNS exposure levels, target engagement, and showed CY6463 to be safe and generally well-tolerated. In this study, several neurophysiological and objective performance measures associated with age-related cognitive decline and neurodegenerative diseases improved in subjects receiving CY6463 including increased alpha and gamma power, improved mismatch negativity (MMN) latency, faster saccadic eye movement (SEM) reaction time.CY6463 administration resulted in improvement in the levels of various neuroinflammatory biomarkers, including alpha-2-macroglobulin (A2M) and Complement C3 (C3). A2M and C3 have been associated with CNS pathology, cognitive decline, and the development of Alzheimer’s disease. ADv Clinical Trial Initiation: The Company anticipates initiating a 12-week Phase 2a clinical trial in patients with ADv midyear. This exploratory trial is designed to evaluate safety, tolerability, and pharmacodynamic effects including impact on disease-specific biomarkers.MELAS Clinical Trial Advancement: Cyclerion has initiated clinical activities for a 29-day open label Phase 2a pilot study in patients with MELAS and anticipates beginning enrollment imminently. A collaboration with a leading MELAS academic center of excellence has also been initiated to further characterize the effects of sGC stimulation in preclinical models of mitochondrial disease and will include assessments of brain health, neuromuscular function, and biochemical markers of mitochondrial dysfunction.Clinical and Scientific Advisory Boards: The Company expanded its expert networks and announced advisory boards comprised of an accomplished and diverse group of academic leaders with expertise that spans neurology clinical development and translational science, as well as CNS disease biology. The advisors’ expertise will support the continued development of the company’s clinical programs and the pipeline.Leadership Transitions: Effective January 1, 2021, the Company announced the promotions of Cheryl Gault to Chief Operating Officer and Anjeza Gjino to Chief Financial Officer. Bill Huyett, the Company’s prior CFO, continues to work part-time as a Strategic Advisor providing strategic, operational, and organizational development support. Dr. Mark Currie, Cyclerion’s prior President and Chief Scientific Officer (CSO), also transitioned to become a Senior Advisor and Chair the Scientific Advisory Board. Dr. Andreas Busch has assumed the Chief Scientific Officer responsibilities.Praliciguat Update: The Company is working to out-license rights to praliciguat, its investigational orally administered, once-daily systemic sGC stimulator.Organization Revamping and Strategic Alignment: The Company has made substantial progress revamping its organization and aligning its capabilities with its CNS focus. With a leaner more externally networked organization, Cyclerion expects significantly reduced operating cash use in 2021, including exiting its current laboratory and office facilities in early 2021, from which it expects annual cash savings of about $10 million. Full Year 2020 Financial Results Cash Position: Cash, cash equivalents, and restricted cash balance on December 31, 2020 was approximately $58 million, as compared to approximately $71 million on September 30, 2020. Research & Development Expenses: Research and development expenses were approximately $56.4 million for the full year 2020, as compared to approximately $95.1 million for the full year 2019. The decrease of approximately $38.7 million was driven by a decrease of approximately $18.0 million in external research costs, primarily related to the completion of praliciguat trials in the prior year, a net decrease of approximately $12.5 million in personnel and related costs due to lower headcount, and a decrease of approximately $8.2 million of facilities and operating costs primarily from our reduced lease footprint. General and Administrative Expenses: General and administrative expenses were approximately $28.8 million for the full year 2020, as compared to approximately $34.4 million for the full year 2019. The decrease of approximately $5.6 million was primarily driven by a decrease in personnel and related cost primarily due to lower average headcount. Net Loss: Net loss was approximately $77.8 million for the full year 2020, as compared to $123.0 million for the full year 2019. Headcount: The Company had 34 employees as of December 31, 2020, not including employees who were impacted by our recent workforce reduction and who are transitioning out by the end of Q1 2021. About CY6463 CY6463 is the first CNS-penetrant sGC stimulator to be developed as a symptomatic and potentially disease modifying therapy for serious CNS diseases. Nitric oxide (NO) is one of several fundamental neurotransmitters, but it has yet to be leveraged for its full CNS therapeutic potential. CY6463 stimulates sGC, a signaling enzyme that responds to the presence of NO, to enhance the body’s natural ability to produce cyclic guanosine monophosphate (cGMP), an important signaling molecule that regulates diverse and critical biological functions in the CNS including neuronal function, neuroinflammation, cellular bioenergetics, and vascular dynamics. An impaired NO-sGC-cGMP signaling pathway is believed to play an important role in the pathogenesis of neurodegenerative diseases and is critical to basic neuronal functions. Agents that stimulate sGC to produce cGMP may compensate for deficient NO signaling. About Cyclerion Therapeutics Cyclerion Therapeutics is a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function. Cyclerion’s lead program is CY6463, a novel, first-in-class, CNS-penetrant, sGC stimulator that modulates a key node in a fundamental CNS signaling network. The multidimensional pharmacology elicited by the stimulation of sGC has the potential to impact a broad range of CNS diseases. CY6463 has shown rapid improvement in biomarkers associated with cognitive impairment and is currently in clinical development for Alzheimer's Disease with Vascular pathology (ADv) and Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS). For more information about Cyclerion, please visit https://www.cyclerion.com/ and follow us on Twitter (@Cyclerion) and LinkedIn (www.linkedin.com/company/cyclerion). Forward Looking Statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the risks listed under the heading “Risk Factors” and elsewhere in our 2020 Form 10-K filed on February 25, 2021. Investors are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and Cyclerion undertakes no obligation to update these forward-looking statements, except as required by law. InvestorsCarlo Tanzi, Ph.D.Kendall Investor Relationsctanzi@kendallir.com

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  • Cyclerion Therapeutics Announces Clinical and Scientific Advisory Boards

    Leading experts in central nervous system (CNS) clinical development and translational sciences to advise company’s advancement of therapeutic pipeline candidates CAMBRIDGE, Mass., Jan. 25, 2021 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function, today announced the appointment of clinical and scientific advisory boards comprised of academic leaders with expertise in CNS diseases and the development of novel therapeutics. “We are pleased to have assembled an accomplished and diverse group of advisors with expertise that spans clinical development in neurology and translational science, as well as CNS disease biology. The advisors’ expertise will be highly valuable for optimizing the development path and therapeutic potential of the company’s pipeline including CY6463, our first-in-class CNS-penetrant sGC stimulator,” said Andreas Busch, Ph.D., Chief Scientific Officer of Cyclerion. “I look forward to working closely with our advisors to advance our promising pipeline, starting first with ADv and MELAS and to explore additional indications associated with cognitive impairment,” said Christopher Wright, M.D., Chief Medical Officer of Cyclerion. Clinical Advisory Board: Andrew E. Budson, M.D.: Chief of Cognitive & Behavioral Neurology and Director of the Center for Translational Cognitive Neuroscience at the Veterans Affairs Boston Healthcare System, Associate Director and Education Leader of the Boston University Alzheimer’s Disease Research Center, Professor of Neurology at Boston University School of Medicine, and Lecturer in Neurology at Harvard Medical School Eric Smith, M.D.: Professor of Neurology and the Katthy Taylor Chair in Vascular Dementia at the University of Calgary, Calgary Stroke ProgramM Brandon Westover, M.D., Ph.D.: Physician Investigator in Neurology at Mass General Research Institute, Associate Professor of Neurology at Harvard Medical School, Associate Neurologist in Neurology at Massachusetts General Hospital, and Co-Founder, Beacon BiosignalsDavid H. Salat, Ph.D.: Director, Brain Aging and Dementia Laboratory, Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital; Associate Professor in Radiology at Harvard Medical School; and Director, Neuroimaging Research for Veterans Center, Veterans Affairs Boston Healthcare System Scientific Advisory Board: Mark Currie, Ph.D. (Chair): External Advisor with over 40 years of experience studying nitric oxide, guanylate cyclases and cGMP signalingRobert C. Malenka, M.D., Ph.D.: Pritzker Professor of Psychiatry and Behavioral Sciences, Director of the Nancy Pritzker Laboratory, and Deputy Director of the Wu Tsai Neurosciences Institute at Stanford UniversityDaniela Salvemini, Ph.D.: Professor of Pharmacology and Physiology and Director of the Henry and Amelia Nasrallah Center for Neuroscience at St. Louis UniversityHarald H.H.W. Schmidt, M.D., Ph.D., PharmD.: Professor of Pharmacology and Chairman of the Department of Pharmacology and Personalized Medicine at Maastricht University About Cyclerion Therapeutics Cyclerion Therapeutics is a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function. Cyclerion’s lead program is CY6463, a first-in-class, CNS-penetrant, sGC stimulator that modulates a key node in a fundamental CNS signaling network. The multidimensional pharmacology elicited by the stimulation of sGC has the potential to impact a broad range of CNS diseases. CY6463 has shown rapid improvement in biomarkers associated with cognitive impairment and is currently in clinical development for Alzheimer's Disease with Vascular pathology (ADv) and Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS). For more information about Cyclerion, please visit https://www.cyclerion.com/ and follow us on Twitter (@Cyclerion) and LinkedIn (www.linkedin.com/company/cyclerion). Forward Looking StatementThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the risks listed under the heading “Risk Factors” and elsewhere in our 2019 Form 10-K filed on March 12, 2020, and in Cyclerion’s subsequent SEC filings, including the Form 10-Qs filed on May 4, 2020, August 3, 2020 and November 5, 2020. Investors are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and Cyclerion undertakes no obligation to update these forward-looking statements, except as required by law. InvestorsCarlo Tanzi, Ph.D.Kendall Investor Relationsctanzi@kendallir.com

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  • How Much Did Cyclerion Therapeutics'(NASDAQ:CYCN) Shareholders Earn From Share Price Movements Over The Last Year?

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  • Cyclerion to Participate in the 39th Annual J.P. Morgan Healthcare Conference and H.C. Wainwright BioConnect Conference

    CAMBRIDGE, Mass., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company developing innovative medicines for people with serious diseases of the central nervous system (CNS), today announced that it will present a corporate overview at upcoming investor conferences: * 39th Annual J.P. Morgan Healthcare Conference. A presentation and Q&A discussion will take place on Thursday, January 14, 2021 at 3:40 p.m. ET and a live webcast may be accessed within the Investors & Media section of the Cyclerion.com website. An archived replay will be available for approximately 90 days following the presentation. * H.C. Wainwright BioConnect Conference. An on-demand presentation will be available on Monday January 11, 2021 at 6:00 a.m. ET at the conference website.About Cyclerion Therapeutics  Cyclerion Therapeutics is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing innovative medicines for people with serious diseases of the central nervous system (CNS). Cyclerion’s lead program is CY6463 a pioneering CNS-penetrant sGC stimulator in clinical development for Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS) and Alzheimer's Disease with Vascular pathology (ADv).For more information about Cyclerion, please visit https://www.cyclerion.com/ and follow us on Twitter (@Cyclerion) and LinkedIn (www.linkedin.com/company/cyclerion).Investors Carlo Tanzi, Ph.D. Kendall Investor Relations ctanzi@kendallir.com

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  • Cyclerion Announces Leadership Transitions

    Anjeza Gjino promoted to Chief Financial Officer; Bill Huyett to transition to Strategic Advisor Cheryl Gault promoted to Chief Operating OfficerAmy Schulman stepping down from Board of DirectorsCAMBRIDGE, Mass., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company developing innovative medicines for people with serious diseases of the central nervous system (CNS), today announced, effective January 1, 2021, the promotions of Cheryl Gault to Chief Operating Officer and Anjeza Gjino to Chief Financial Officer. Bill Huyett, the Company’s current CFO, will continue to work part-time as a Strategic Advisor providing strategic, operational, and organizational development insight.Cyclerion also announced that Amy Schulman, Managing Director of Polaris Partners, will be stepping down from the Board of Directors. Terrance McGuire, Co-founder and General Partner of Polaris Partners, continues to serve on the Board of Directors.“Cyclerion puts a high priority on recruiting and developing outstanding talent and preparing them to take on broader responsibilities. Cheryl and Anjeza are terrific leaders who have made important contributions to Cyclerion, and I congratulate them on their expanded roles. I am pleased that we will continue to benefit from Bill’s strategic acumen going forward. I also want to express my deep appreciation to Amy Schulman for her service as a founding member of the Company’s Board of Directors,” said Peter Hecht, Ph.D., Cyclerion’s Chief Executive Officer.The Cyclerion executive team directly reporting to Dr. Hecht includes Andy Busch, Ph.D., Chief Scientific Officer; Cheryl Gault, Chief Operating Officer; Anjeza Gjino, Chief Financial Officer; and Chris Wright, M.D., Ph.D., Chief Medical Officer.Anjeza Gjino was Vice President, Finance and Corporate Secretary and helped lead the execution of the Company’s spin-off, the creation of the Company’s financial systems and processes, its strategic funding and capital allocation efforts, and also has served as Corporate Secretary. Previously, Ms. Gjino served as head of Financial Planning and Analysis at Ironwood Pharmaceuticals, supporting the transition to commercialization. Earlier, Ms. Gjino held various finance roles at PerkinElmer. While at Ironwood and PerkinElmer, she provided financial counsel that included strategic planning, portfolio optimization, business development and commercial execution. Ms. Gjino holds an MBA from the Massachusetts Institute of Technology and a BS in corporate finance from Bentley University.Cheryl Gault was Senior Vice President and Head of Strategy and Corporate Development. Ms. Gault has been responsible for corporate and business development, program management, portfolio strategy, new product planning, and corporate strategy functions. Previously, Ms. Gault served as Vice President, Commercial Strategy & New Product Planning at Ironwood, where she partnered with the R&D team to advance differentiated pipeline programs and played a central role in the launch of LINZESS®, the market leader in irritable bowel disease. Prior to that, she was at Genzyme Corporation in a variety of sales and marketing roles in the biosurgery division, including in a leadership role in the launch of Synvisc-ONE, an injectable for the treatment of osteoarthritis. Ms. Gault obtained her BA in marketing from Boston College.About Cyclerion Therapeutics Cyclerion Therapeutics is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing innovative medicines for people with serious diseases of the central nervous system (CNS). Cyclerion’s lead program is CY6463, previously known as IW-6463, a pioneering CNS-penetrant sGC stimulator in clinical development for Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS) and Alzheimer's Disease with Vascular pathology (ADv).For more information about Cyclerion, please visit https://www.cyclerion.com/ and follow us on Twitter (@Cyclerion) and LinkedIn (www.linkedin.com/company/cyclerion).Forward Looking Statement – This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the risks listed under the heading “Risk Factors” and elsewhere in our 2019 Form 10-K filed on March 12, 2020, and in Cyclerion’s subsequent SEC filings, including the Form 10-Qs filed on May 4, 2020, August 3, 2020 and November 5, 2020. Investors are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and Cyclerion undertakes no obligation to update these forward-looking statements, except as required by law.Investors Carlo Tanzi, Ph.D. Kendall Investor Relations ctanzi@kendallir.com

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  • Is Cyclerion Therapeutics, Inc. (CYCN) A Good Stock To Buy?

    We know that hedge funds generate strong, risk-adjusted returns over the long run, therefore imitating the picks that they are collectively bullish on can be a profitable strategy for retail investors. With billions of dollars in assets, smart money investors have to conduct complex analyses, spend many resources and use tools that are not always […]

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  • Andreas Busch Is The Chief Innovation Officer of Cyclerion Therapeutics, Inc. (NASDAQ:CYCN) And They Just Picked Up 96% More Shares

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  • Cyclerion Therapeutics Reports Third Quarter 2020 Financial Results and Recent Corporate Updates

    Positive IW-6463 translational pharmacology study in healthy elderly subjects showed significant improvements in multiple measures associated with age-related cognitive decline and neurodegenerative diseasesCompany revamping its organization to focus on critical IW-6463 CNS program priorities; expects 2021 average cash use reduction of approximately 50% from Q3 2020 levels Company anticipates that its current cash will be sufficient to fund its current CNS priorities, including the MELAS and ADv studies, and further characterization of IW-6463 novel pharmacologyMELAS study expected to initiate in Q4 2020 with top-line readout in mid-2021 and the ADv study expected to initiate in 2021CAMBRIDGE, Mass., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company developing innovative medicines for people with serious diseases of the central nervous system (CNS), reported financial results for the third quarter ended September 30, 2020 and provided general corporate and pipeline updates.“We are highly encouraged by the data from our IW-6463 translational pharmacology study showing robust and consistent positive effects on multiple measures of brain neurophysiology that are associated with age-related cognitive decline and neurodegenerative diseases,” said Peter Hecht, Ph.D., Chief Executive Officer of Cyclerion. “IW-6463 is a promising new approach for CNS diseases that have very limited therapeutic options today. Building on the exciting IW-6463 translational pharmacology study results and leveraging our team’s neuroscience expertise, the Company will concentrate on developing meaningful treatments for serious CNS diseases. Our immediate priority is to rapidly and efficiently further assess the clinical profile of IW-6463, and we look forward to initiating enrollment in our MELAS study this quarter and in our ADv study in 2021.”Recent Program and Business Updates * IW-6463 Program Update: Cyclerion announced promising results from its Phase 1 translational pharmacology study of IW-6463, the first soluble guanylate cyclase (sGC) stimulator in clinical development for CNS disorders. Treatment with IW-6463 in the 15-day 24-subject crossover study confirmed and extended results seen in the earlier Phase 1 study: once daily oral treatment demonstrated blood-brain-barrier penetration, desired CNS exposure levels, target engagement and showed IW-6463 to be safe and generally well-tolerated. In this study, subjects receiving IW-6463 showed improvements in several neurophysiological and objective performance measures that are associated with age-related cognitive decline and neurodegenerative diseases. Effects on cerebral blood flow and markers of bioenergetics were not observed in this study of healthy elderly subjects. These results support the ongoing development of IW-6463 in serious CNS diseases. Cyclerion expects to begin enrolling its Phase 2 clinical trial in patients with Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like episodes (MELAS) this quarter. The Company will use the findings of the translational pharmacology study, in addition to observations from the previous Phase 1 study of 110 healthy subjects, to inform further clinical development activities, including the initiation of a planned Phase 2 clinical trial in Alzheimer’s disease with vascular pathology (ADv) in 2021, as well as to explore other potential indications. In July, the Company announced that it has been awarded a grant from the Alzheimer's Association’s Part the Cloud-Gates Partnership Grant Program. This award will support the Company’s upcoming Phase 2 trial of IW-6463 in ADv. The award provides Cyclerion with $2 million of funding over the next 2 years. * Sickle Cell Program Update: The Company announced top-line results from its STRONG-SCD study of olinciguat, an investigational, orally-administered, once daily, vascular sGC stimulator for the potential treatment of sickle cell disease (SCD). Olinciguat was generally well tolerated across all doses. Results did not demonstrate adequate activity to support further internal clinical development. Cyclerion intends to complete its analysis of the study results and present or publish them in a future medical forum. * Praliciguat Update: The Company is working to out-license rights to praliciguat, its orally administered, once-daily systemic sGC stimulator, and has expanded to discussions beyond treatment of cardiometabolic disorders to include additional indications where sGC stimulators have demonstrated efficacy. * Financing: On July 29, Cyclerion announced a private equity investment of $24 million. On September 3, 2020, the Company entered into a Sales Agreement with Jefferies LLC with respect to an at-the-market offering (ATM Offering) which allows the sale of up to $50M of shares from time to time over the next three years at the open market price. As of September 30, 2020, no shares have been issued or sold under the ATM Offering. * Strategic Update and Organization Restructuring: Consistent with its previously announced intent to focus on developing treatments for serious CNS diseases, Cyclerion’s investments will be directed to fund its current CNS priorities, including the upcoming MELAS study, the planned ADv study and further characterization of IW-6463 pharmacology. The Company will revamp its organization beginning immediately to align with these priorities. The Company expects to take an aggregate charge for one-time employee-related costs of approximately $5 million that is expected to be incurred primarily in Q4 2020 and realize annual cash savings of approximately $10 million. The Company also intends to exit its current laboratory and office facilities in early 2021, from which it expects annual cash savings of about $10 million.  These and other spending reductions are expected to lower the Company’s average quarterly cash use in 2021 by about 50% from the Q3 2020 level of approximately $15 million. The Company anticipates that its current cash will be sufficient to fund its current CNS priorities, including the ongoing MELAS study, the planned ADv study and further characterization of IW-6463 pharmacology. * Transition of President and Chief Scientific Officer: Dr. Mark Currie, Cyclerion’s President and Chief Scientific Officer (CSO), will transition at year end to become a senior advisor. He will continue to assist the Company on scientific and strategic matters related to the development of the CNS portfolio. Dr. Andreas Busch, Chief Innovation Officer, will effective immediately assume Dr. Currie’s CSO responsibilities while Dr. Currie continues as President through year end. Third Quarter 2020 Financial Results * Cash Position: Cash, cash equivalents, and restricted cash balance on September 30, 2020 was approximately $71 million, as compared to approximately $61 million on June 30, 2020. * Research & Development Expenses: Research and development expenses were approximately $13.7 million for the third quarter of 2020, as compared to approximately $22.3 million for the third quarter of 2019. The decrease of approximately $8.6 million was driven by a decrease of approximately $3.3 million in salaries and other employee-related expenses primarily due to lower average headcount, a decrease of approximately $2.0 million of facilities and operating costs allocated to research and development primarily from our reduced lease footprint and a decrease of approximately $3.3 million in external research costs, primarily related to the completion of praliciguat trials in the prior year. * General and Administrative Expenses: General and administrative expenses were approximately $8.0 million for the third quarter of 2020, as compared to approximately $7.1 million for the third quarter of 2019. The increase was primarily due to professional fees supporting our recent financing activities, partially offset by a net decrease in employee-related and operating expenses due to lower average headcount. * Net Loss: Net loss was approximately $18.8 million for the third quarter of 2020, as compared to $27.3 million for the third quarter of 2019.About IW-6463IW-6463 is the first CNS-penetrant sGC stimulator to be developed as a symptomatic and potentially disease modifying therapy for serious CNS diseases. Nitric oxide (NO) is one of several fundamental neurotransmitters, but it has yet to be leveraged for its full CNS therapeutic potential. IW-6463 stimulates sGC, a signaling enzyme that responds to the presence of NO, to enhance the body’s natural ability to produce cyclic guanosine monophosphate (cGMP), an important signaling molecule. An impaired NO-sGC-cGMP signaling pathway is believed to play an important role in the pathogenesis of neurodegenerative diseases and is critical to basic neuronal functions. Agents that stimulate sGC to produce cGMP may compensate for deficient NO signaling.About Cyclerion Therapeutics Cyclerion Therapeutics is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing innovative medicines for people with serious diseases of the central nervous system (CNS). Cyclerion’s lead program is IW-6463 is a pioneering CNS-penetrant sGC stimulator in clinical development for Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS) and Alzheimer's Disease with Vascular pathology (ADv).For more information about Cyclerion, please visit https://www.cyclerion.com/ and follow us on Twitter (@Cyclerion) and LinkedIn (www.linkedin.com/company/cyclerion).Forward Looking Statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties, including statements about the results and conduct of our clinical trials; our interpretation of the data from the clinical trials; the clinical potential of our molecules; the anticipated timing of our planned clinical trials; our future business focus; the business and operations of Cyclerion; and our future financial performance and expense levels. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the risks listed under the heading “Risk Factors” and elsewhere in our 2019 Form 10-K filed on March 12, 2020, and in Cyclerion’s subsequent SEC filings, including the Form 10-Qs filed on May 4, 2020, August 3, 2020 and November 5, 2020. Investors are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and Cyclerion undertakes no obligation to update these forward-looking statements, except as required by law.Investors Carlo Tanzi, Ph.D. Kendall Investor Relations ctanzi@kendallir.com

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  • Why Cyclerion Therapeutics Is Crashing Today

    Shares of clinical-stage biotech Cyclerion Therapeutics (NASDAQ: CYCN) are down by an eye-popping 48% as of noon EDT Wednesday. The small-cap biotech's stock is crashing in response to a negative midstage trial result for its sickle cell disease candidate olinciguat. Sickle cell disease is a rare blood disorder with limited treatment options.

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  • Cyclerion Sinks As Biopharma Shelves Sickle Cell Disease Study

    Cyclerion Therapeutics Inc (NASDAQ: CYCN) shares are pulling back sharply following a couple of clinical trial updates from the company.What Happened: Cambridge, Massachusetts-based Cyclerion said its mid-stage investigational asset olinciguat did not show adequate activity to support further internal clinical development of it as a potential treatment for sickle cell disease.Olinciguat, a vascular sGC stimulator, was found to be well tolerated across all dose ranges, top-line results from the Phase 2 STRONG-SCD study showed.Separately, the company announced positive results from a Phase 1 translational pharmacology study of IW-6463, a soluble guanylate cyclase stimulator being developed for CNS disorders.IW-6463, while found safe and generally well-tolerated, also resulted in meaningful improvements in certain neurophysiological and objective performance measures that are associated with age-related cognitive decline and neurodegenerative diseases, Cyclerion said.Effects on cerebral blood flow and markers of bioenergetics were not observed in this study.Related Link: FDA's COVID-19 Vaccine Guidance Shows 'Substantial' Obligations For Developers: AnalystWhat's Next: Cyclerion intends to complete analysis of the results of the STRONG-SCD olinciguat study and present or publish them in a future forum.In the wake of the fiasco with the sickle cell disease indication, the company plans to focus on treatments for serious diseases of the central nervous system.With the Phase 1 IW-6463 results supporting the investigational compound's ongoing development, Cyclerion said it will soon begin enrolling its Phase 2 clinical trial in mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes.The company also said it will use the information gleaned from the translational pharmacology study and the previous Phase 1 study of IW-6463 to take up further clinical development activities, including initiation of a planned Phase 2 clinical trial in Alzheimer's disease with vascular pathology in 2021, as well as to explore other potential indications.Cyclerion shares were slumping 45% to $3.88, their lowest level since early August.See more from Benzinga * Options Trades For This Crazy Market: Get Benzinga Options to Follow High-Conviction Trade Ideas * The Week Ahead In Biotech: FDA Decisions For Mesoblast And Eton, Coronavirus Vaccine Updates(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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  • Cyclerion Announces Positive Data from IW-6463 CNS Translational Pharmacology Study in Healthy Elderly Subjects

    Showed significant improvements in neurophysiological and objective performance measures associated with age-related cognitive decline and neurodegenerative diseasesConfirmed blood-brain-barrier penetration, desired CNS exposure levels, target engagement and a favorable safety and tolerability profileProceeding with its upcoming Phase 2 clinical trials in Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like episodes (MELAS) and Alzheimer’s disease with vascular pathology (ADv)Company to focus on developing treatments for serious diseases of the central nervous systemWebcast at 8:30 a.m. ET todayCAMBRIDGE, Mass., Oct. 14, 2020 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company developing innovative medicines for people with serious diseases of the central nervous system (CNS), today announced results from its Phase 1 translational pharmacology study of IW-6463, the first soluble guanylate cyclase (sGC) stimulator in clinical development for CNS disorders.Treatment with IW-6463 in this 15-day 24-subject crossover study confirmed and extended results seen in earlier Phase 1 studies: once daily oral treatment demonstrated blood-brain-barrier penetration, desired CNS exposure levels and target engagement. In this study, IW-6463 was shown to be safe and generally well-tolerated. Subjects receiving IW-6463 showed meaningful improvements in certain neurophysiological and objective performance measures that are associated with age-related cognitive decline and neurodegenerative diseases. Effects on cerebral blood flow and markers of bioenergetics were not observed in this study.These results support the ongoing development of IW-6463 in serious CNS diseases. Cyclerion will soon begin enrolling its Phase 2 clinical trial in Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like episodes (MELAS). Over the coming months the company will use the findings of the translational pharmacology study, in addition to observations from the previous Phase 1 study of 110 healthy subjects, to inform further clinical development activities, including the initiation of a planned Phase 2 clinical trial in Alzheimer’s disease with vascular pathology (ADv) in 2021, as well as to explore other potential indications."These data show that IW-6463 has a positive effect on brain neurophysiology that has been associated with age-related cognitive decline and neurodegenerative diseases. Furthermore, these data support the role of nitric oxide as an important neurotransmitter whose potential therapeutic benefits remain underexplored,” said Chris Wright, M.D., Ph.D., Cyclerion’s Chief Medical Officer. “We expect to initiate enrollment of the MELAS study later this year and are excited to incorporate the learnings from our translational pharmacology study into the design of our planned Phase 2 ADv study. Looking beyond these studies, we will evaluate the potential of IW-6463 to provide clinical benefit for people suffering from a range of serious CNS diseases. Seeing such robust, consistent and rapidly occurring changes in this study gives us confidence that IW-6463 targets a relevant mechanism in cognition and neurodegeneration.”IW-6463 Phase 1 Translational Pharmacology Study Design The exploratory Phase 1 study conducted in 24 healthy elderly volunteers age 65 and older evaluated safety and tolerability, pharmacokinetics, measures of CNS pharmacodynamic activity, including cerebral blood flow, and a range of measures associated with age-related cognitive decline and neurodegenerative diseases. Participants received study drug once daily across two 15-day dosing periods (Period 1 and Period 2). The dosing periods were separated by a 27-day washout. Participants were randomized to a sequence of receiving IW-6463 for Period 1 and then placebo for Period 2, or vice versa. All 24 subjects completed the first period, and 12 completed the entire crossover due to operational challenges associated with COVID-19.IW-6463 Phase 1 Translational Pharmacology Study Results IW-6463 demonstrated blood-brain-barrier penetration, desired CNS exposure levels and engagement of the targeted nitric oxide (NO)-signaling pathway. Mean concentrations of IW-6463 in cerebrospinal fluid (CSF) achieved levels projected to be pharmacologically active based on preclinical studies. Consistent with this, pathway target engagement was confirmed through monitoring blood pressure and CSF cyclic guanosine monophosphate (cGMP) levels. This study reproduced the brain exposure and safety and tolerability data set of the prior Phase 1 study in young healthy volunteers (n=110).Key results in this healthy elderly population demonstrate an impact on certain neurophysiological and objective performance measures known to be affected by aging and neurodegenerative disease with cognitive impairment. Specifically, Cyclerion observed: * positive impact on posterior alpha power, a measure that may reflect attentional processing capabilities, with a significant increase from baseline to day 15 in the IW-6463 treatment group, compared to the placebo group (p<0.02). Directional improvements in gamma power, a measure associated with memory and attention processing, as well as in other spectral power rhythms, buttress this finding. * improvements in the N200 auditory event-related potential, a measure associated with stimulus identification and distinction. Latency was significantly shorter with IW-6463 at day 14 compared to untreated subjects (p=0.02). * positive effects of IW-6463 on an objective saccadic eye movement task that is related to attention and cognitive processing. Saccadic reaction times were significantly shorter (p=0.02) and there was a trend increase in saccadic velocity (p=0.07). Cyclerion will continue to analyze the data to more fully understand the relationship between IW-6463 and the biomarker effects observed. All p-values are unadjusted for multiplicity. The company intends to present further results of this exploratory study, which represents a novel area of CNS science, in peer-reviewed journals and medical conferences.“These results bring into focus the exciting opportunity to deliver innovative medicines, with the possibility to improve brain function, for an area in desperate need of new treatment options,” said Andy Busch, Ph.D., Chief Innovation Officer. “We are working at the forefront of CNS drug development and we are learning a great deal about this novel mechanism of action. IW-6463 is a promising molecule with potential in a variety of serious CNS diseases, and we look forward to building on the insights from this study to drive the path forward for the company, the compound, and patients in need beyond our planned clinical trials and current target indications.”“These exciting and unique results demonstrate that stimulating sGC can positively modulate alpha rhythm and N200 in the elderly, potentially improving age-related deficits in these neurophysiologic measures,” said Brandon Westover, M.D., Ph.D., McCance Center for Brain Health, Associate Professor, Neurology, Massachusetts General Hospital and Harvard Medical School, and Co-Founder of Beacon Biosignals. “Given the relationships between alpha rhythm, N200, brain aging, and cognitive impairment, further study is warranted in patients with debilitating age-associated neurodegenerative diseases.”The company’s planned Phase 2 trial of IW-6463 in ADv will be supported partially by a grant from the Alzheimer's Association’s Part the Cloud-Gates Partnership Grant Program, which is expected to provide Cyclerion with $2 million of funding over the next two years.About IW-6463 IW-6463, a CNS-penetrant sGC stimulator, is being developed as a symptomatic and potentially disease modifying therapy for serious CNS diseases. Nitric oxide (NO) is one of several fundamental neurotransmitters, but it has yet to be leveraged for its full CNS therapeutic potential. IW-6463 stimulates sGC, a signaling enzyme that responds to the presence of NO, to enhance the body’s natural ability to produce cyclic guanosine monophosphate (cGMP), an important signaling molecule, naturally. An impaired NO-sGC-cGMP signaling pathway is believed to play an important role in the pathogenesis of neurodegenerative diseases and is critical to basic neuronal functions. Agents that stimulate sGC to produce cGMP may compensate for deficient NO signaling.About Cyclerion Therapeutics Cyclerion Therapeutics is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing innovative medicines for people with serious diseases of the central nervous system (CNS). Cyclerion’s lead program is IW-6463, a pioneering CNS-penetrant sGC stimulator in clinical development for Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS) and Alzheimer's disease with vascular pathology (ADv).For more information about Cyclerion, please visit https://www.cyclerion.com/ and follow us on Twitter (@Cyclerion) and LinkedIn (www.linkedin.com/company/cyclerion).Webcast and Conference Call Details Cyclerion will host a webcast, with accompanying slide presentation, on Wednesday, October 14, 2020 at 8:30 a.m. EDT to discuss the study results and plans for further development of IW-6463. To access the webcast, please visit https://edge.media-server.com/mmc/p/2zzfo75c. To access the call, please dial (800) 360-8162 (toll-free) or (409) 937-8760 (international) and provide the conference ID 2554703. The archived webcast will remain available online for 30 days. For more information, please visit the investor section of Cyclerion’s website at www.cyclerion.comForward Looking Statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties, including statements about the results and conduct of our Phase 1 translational pharmacology clinical trial of IW-6463; our interpretation of the data from the clinical trial; the potential of further evaluation of IW-6463; the clinical potential of IW-6463; our future business focus; the anticipated timing of our planned clinical trials; and the receipt of cash from the Alzheimer's Association’s Part the Cloud-Gates Partnership Grant Program, which is subject to final documentation. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the risks listed under the heading “Risk Factors” and elsewhere in our 2019 Form 10-K filed on March 12, 2020, and in Cyclerion’s subsequent SEC filings, including the Form 10-Q filed on May 4, 2020 and the Form 10-Q filed on August 3, 2020. Investors are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and Cyclerion undertakes no obligation to update these forward-looking statements, except as required by law.Investors Carlo Tanzi, Ph.D. Kendall Investor Relations ctanzi@kendallir.comMedia Amanda Sellers Verge Scientific Communications asellers@vergescientific.com

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  • Cyclerion Announces Phase 2 STRONG-SCD Study Results in Patients with Sickle Cell Disease

    Study results do not support further internal developmentCAMBRIDGE, Mass., Oct. 14, 2020 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company, today announced top-line results from its STRONG-SCD study of olinciguat, an investigational, orally-administered, once daily, vascular sGC stimulator for the potential treatment of sickle cell disease (SCD). Olinciguat was generally well tolerated across all dose ranges. Results did not demonstrate adequate activity to support further internal clinical development. Cyclerion intends to complete its analysis of the study results and present or publish them in a future forum. “We would like to thank all of the sickle cell patients who participated in the STRONG-SCD study, the SCD advocacy community, and the investigators and study staff who focused their time and efforts on helping us better understand the potential of olinciguat in sickle cell disease,” said Peter Hecht, Ph.D., Chief Executive Officer of Cyclerion. “While we are disappointed that we won’t be contributing a much-needed new treatment option for SCD, we are continuing to analyze the data to understand several potential biomarker signals, including inflammation, as we explore partnership options for this program.”As described in the Company’s IW-6463 press release also issued today, Cyclerion expects to be focused on the development of treatments for serious diseases of the central nervous system (CNS).About STRONG-SCD Study The STRONG-SCD study is a randomized, placebo-controlled, dose-ranging Phase 2 study of 70 participants designed to evaluate safety, tolerability, and pharmacokinetics of olinciguat, compared to placebo, as well as to explore effects on daily symptoms and biomarkers of disease activity when dosed over a 12-week treatment period.About Cyclerion Therapeutics Cyclerion Therapeutics is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing innovative medicines for people with serious diseases of the central nervous system (CNS). Cyclerion’s lead program is IW-6463, a pioneering CNS-penetrant sGC stimulator in clinical development for Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS) and Alzheimer's Disease with Vascular pathology (ADv).For more information about Cyclerion, please visit https://www.cyclerion.com/ and follow us on Twitter (@Cyclerion) and LinkedIn (www.linkedin.com/company/cyclerion).Forward Looking Statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties, including statements about the results and conduct of our Phase 2 proof-of-concept clinical trial of olinciguat; our interpretation of the data from the clinical trial; the potential further evaluation of olinciguat; the potential strategic options for olinciguat; the clinical potential of olinciguat; our future business focus; advancing our other clinical trials; and the business and operations of Cyclerion. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Investors are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and Cyclerion undertakes no obligation to update these forward-looking statements, except as required by law. Applicable risks and uncertainties include the risks listed under the heading “Risk Factors” and elsewhere in our 2019 Form 10-K filed on March 12, 2020, and in Cyclerion’s subsequent SEC filings, including the Form 10-Q filed on May 4, 2020 and the Form 10-Q filed on August 3, 2020.Investors Carlo Tanzi, Ph.D. Kendall Investor Relations ctanzi@kendallir.comMedia Amanda Sellers Verge Scientific Communications asellers@vergescientific.com

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