PRTA

Prothena Corporation plc Ordinary Shares Nasdaq Global Select
$50.31
Open: $45.88 High: $55 Low: $45.405 Close: $50.3
Range: 2021-06-23 - 2021-06-24
Volume: 852,542
Market: Open
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PRTA
Prothena Corporation plc Ordinary Shares Upper George's Street Dublin , A96 T927 http://www.prothena.com
Prothena Corp PLC is a biotechnology company. It discovers and develops novel antibodies for the potential treatment of a broad range of diseases that involve protein misfolding or cell adhesion.
  • CEO: Gene Kinney
  • Employees: 125
  • Sector: Healthcare
  • Industry: Biotechnology
PRTA News
Latest news about the PRTA
  • Prothena Announces Bristol Myers Squibb Opt-in of Anti-Tau PRX005 as the First Program from Global Neuroscience Research and Development Collaboration

    Prothena to receive $80 million from Bristol Myers Squibb for exclusive US license to PRX005; Next option for worldwide rights following completion of Phase 1PRX005 is an investigational best-in-class anti-tau antibody targeting the microtubule binding region of tau for the treatment of Alzheimer’s diseasePhase 1 study has initiated DUBLIN, Ireland, June 24, 2021 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with a robust pipeline of novel investigatio

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  • Prothena Corp: Why Jeffries Analyst Almost Doubled His Price Target On the Stock?

    Prothena Corporation (NASDAQ: PRTA) is a late-stage clinical company with a pipeline of novel investigational therapeutics for the potential treatment of diseases including amyloidosis, Alzheimer’s disease, Parkinson’s disease, and other neurodegenerative diseases. On June 7, the U.S. Food and Drug Administration (FDA) approved Biogen’s (BIIB) treatment for Alzheimer’s disease, aducanumab. Following this development, Jeffries analyst Michael Yee believes that there is potentially more value to b

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  • Why Biogen, Lilly, and Prothena Stocks Soared This Week

    The FDA's approval of Biogen's Aduhelm in treating Alzheimer's disease boosted all three stocks.

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  • Prothena to Participate in JMP Securities Life Sciences Conference on June 16

    DUBLIN, Ireland, June 10, 2021 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, today announced that members of its senior management team will participate in a fireside chat at the JMP Securities Life Sciences Conference on Wednesday, June 16 at 3:00 PM ET A live webcast of the fireside chat can be accessed through the investor relations section of the Compan

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  • Prothena (PRTA) Up 78.2% Since Last Earnings Report: Can It Continue?

    Prothena (PRTA) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.

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  • Prothena (PRTA) Moves 5.9% Higher: Will This Strength Last?

    Prothena (PRTA) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock suggests that there could be more strength down the road.

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  • Prothena Announces Appointment of Sanjiv Patel, MBBS, to its Board of Directors

    DUBLIN, Ireland, May 20, 2021 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, announced today the appointment of Sanjiv K. Patel, MBBS, MA, MBA, to its Board of Directors. “Sanjiv is an experienced leader with significant industry experience that uniquely positions him to guide us as we look towards transitioning to a fully integrated research, development and commercial biotechnology company,” commented Lars Ekman, MD, PhD, Prothena’s Chairman. “We welcome Sanjiv to our Board and look forward to his contributions in advising Prothena during this transformational period.” “I’m excited to join the Board at this pivotal stage for Prothena. The Company’s leading protein dysregulation expertise is clearly reflected in its robust and promising pipeline of novel programs in areas of high unmet need,” said Dr. Patel. “I look forward to working with the Prothena team to contribute strategically to the Company’s continued growth.” Sanjiv K. Patel, MBBS is President, Chief Executive Officer, and a member of the board of Relay Therapeutics, a clinical-stage precision medicine company. Before joining Relay Therapeutics, Dr. Patel served in various roles at Allergan, Inc. for over a decade. He most recently served as Allergan’s Executive Vice President, Chief Strategy Officer and previously as Corporate Vice President, Global Strategic Marketing and Global Health Outcomes. Prior to this, he was a management consultant at The Boston Consulting Group and practiced as a surgeon within the UK’s National Health Service. Dr. Patel earned his MBBS from University of London, his MA in Medical Sciences from the University of Cambridge, his MRCS from the Royal College of Surgeons of England, and his MBA from INSEAD. About Prothena Prothena Corporation plc is a late-stage clinical company with a robust pipeline of novel investigational therapeutics, built on protein dysregulation expertise, with the potential to change the course of devastating rare peripheral amyloid and neurodegenerative diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis, Alzheimer’s disease, Parkinson’s disease and a number of other neurodegenerative diseases. For more information, please visit the Company’s website at www.prothena.com and follow the Company on Twitter @ProthenaCorp. Investors & MediaJennifer Zibuda, Director, Investor Relations & Communications650-837-8535, jennifer.zibuda@prothena.com

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  • Prothena (PRTA) Q1 Loss Wider Than Expected, Pipeline in Focus

    Prothena (PRTA) reports a wider loss in the first quarter of 2021. The pipeline remains in focus with the planned initiation of three late-stage studies for birtamimab, prasinezumab and PRX004.

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  • Prothena Reports First Quarter 2021 Financial Results and Provides Updated Financial Guidance and R&D Update

    Net cash used in operating and investing activities was $33.7 million in the first quarter; quarter-end cash and restricted cash position of $345.7 million provides funding to advance the R&D pipeline Announced confirmatory Phase 3 AFFIRM-AL study of birtamimab in Mayo Stage IV patients with AL amyloidosis under SPA agreement with FDAAchieved $60 million milestone from Roche for first patient dosed in Phase 2b PADOVA study of prasinezumab in patients with early Parkinson’s diseaseHighlighted data in oral presentations at AD/PD in March and AAN in April for three programs in our neurodegenerative and rare peripheral amyloid pipeline DUBLIN, Ireland, May 11, 2021 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with a robust pipeline of novel investigational therapeutics built on protein dysregulation expertise, today reported financial results for the first quarter of 2021. In addition, the Company provided an update on its R&D programs and 2021 financial guidance. “We recently welcomed Hideki Garren to Prothena as Chief Medical Officer and look forward to his expertise contributing to our transition to a fully integrated research, development and commercial biotechnology company,” said Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena. “The oral presentations at AD/PD and AAN highlight the continued translation of our differentiated protein dysregulation scientific platform from preclinical findings to clinical benefit for patients across multiple programs in our portfolio. We remain on track for significant news flow this year with the planned initiation of three late-stage clinical studies for birtamimab, prasinezumab and PRX004. We will advance two programs in our Alzheimer’s portfolio towards the clinic over the next 12 months, with IND filings for our anti-tau PRX005 and anti-abeta PRX012 programs, designed to be best-in-class treatments for Alzheimer’s disease. Additionally, our cash position was strengthened by our public offering in March and will be further bolstered when we receive the $60 million milestone earned from Roche. Together this enhances our ability to fund the company through multiple key clinical milestones.” First Quarter and Recent Highlights: Birtamimab, a potential treatment for AL amyloidosis, is a humanized monoclonal antibody designed to directly neutralize soluble toxic aggregates and promote clearance of amyloid that causes organ dysfunction and failure Based on the significant survival benefit favoring birtamimab, from the previous VITAL study in a subset of patients categorized as Mayo Stage IV at baseline (HR=0.413, p=0.025, over 9 months), and multiple in-depth discussions with the U.S. Food and Drug Administration (FDA), Prothena announced plans in February 2021 to advance birtamimab into the confirmatory Phase 3 AFFIRM-AL study in Mayo Stage IV patients with AL amyloidosis. AFFIRM-AL is a global, registration-enabling Phase 3 study that will be conducted under a Special Protocol Assessment (SPA) agreement with FDA to enable registration at p≤0.10 for the primary endpoint of all-cause mortality. Prasinezumab, a potential treatment for Parkinson’s disease, is a humanized monoclonal antibody designed to target a key epitope within the C-terminus of alpha-synuclein and is the focus of the worldwide collaboration with Roche $60 million milestone earned with first patient dosed in PADOVA study in the second quarterTwo oral presentations by Roche at the 15th International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2021) released new data from Part 1 of the Phase 2 PASADENA study. The first presentation highlighted newly presented data from a pre-specified exploratory subgroup analysis showing slowing of clinical decline with prasinezumab was more evident in subgroups with more rapid disease progression. Separately, new digital biomarker data presented from Roche’s remote monitoring technology used in the study was consistent with a potential disease modifying effect of prasinezumab in slowing Parkinson’s disease progression. PRX004, a potential treatment for ATTR amyloidosis, is a humanized monoclonal antibody designed to deplete the pathogenic, non-native forms of the TTR protein Oral presentation at the American Academy of Neurology (AAN) 2021 Virtual Meeting featuring results from the Phase 1 study of PRX004 in ATTR amyloidosis. PRX004 showed favorable results as demonstrated by slowing of neuropathy progression for all 7 evaluable patients at 9 months, including improvement in neuropathy in 3 of the 7 patients, and improved cardiac systolic function for all 7 patients. In this Phase 1 study, PRX004 was found to be generally safe and well tolerated across all dose levels. PRX005, a potential treatment for Alzheimer’s disease (AD), is an investigational antibody that targets tau, a protein implicated in diseases including AD, frontotemporal dementia (FTD), progressive supranuclear palsy (PSP), chronic traumatic encephalopathy (CTE) and other tauopathies. Oral presentation at AD/PD 2021 highlighting new preclinical data demonstrating that targeting an epitope within the microtubule binding region (MTBR) of tau with PRX005 resulted in superior attributes for the potential treatment of AD. PRX005 demonstrated significant inhibition of cell-to-cell transmission and neuronal internalization in vitro and in vivo, and slowed pathological progression in a tau transgenic mouse model. Corporate Appointed Hideki Garren, M.D., Ph.D., as Chief Medical Officer, responsible for leading the clinical and medical organizations to advance Prothena’s clinical pipeline. Dr. Garren joined Prothena after serving as Vice President, Global Head of Neuroimmunology at F. Hoffman-La Roche Ltd. (Roche) & Genentech Inc.Executed a public offering in March that raised net proceeds of approximately $78 million through the issuance of 4,025,000 ordinary shares Upcoming Milestones: Birtamimab Phase 3 AFFIRM-AL study initiation expected mid-2021VITAL study 9-month results expected to be presented at a medical conference in 2021 Prasinezumab Results from Part 2 of the PASADENA study expected to be presented at an upcoming medical conference PRX004 Phase 2/3 study in patients with ATTR-cardiomyopathy expected to initiate 4Q 2021 PRX005 IND expected by 3Q 2021$80 million potential payment from Bristol Myers Squibb upon exercising their US license option in 2021 PRX012, a potential treatment for Alzheimer’s disease, is a high affinity monoclonal antibody targeting a key epitope within the N-terminus of Aβ IND expected by 1Q 2022 Upcoming Investor Conferences Members of the senior management team will present and participate in investor meetings at the following upcoming investor conferences: BofA Securities 2021 Virtual Health Care Conference, May 13, 2021, at 8:45 AM ETRBC Capital Markets Global Healthcare Conference, May 19, 2021 at 8:35 AM ETJefferies Virtual Healthcare Conference, June 1, 2021 at 9:00 AM ET First Quarter 2021 Financial Results and Updated 2021 Financial Guidance For the first quarter of 2021, Prothena reported a net loss of $36.7 million, as compared to a net loss of $23.6 million for the first quarter of 2020. Net loss per share for the first quarter of 2021 was $0.91, as compared to a net loss per share of $0.59 for the first quarter of 2020. Prothena reported total revenue of $0.2 million for the first quarter of 2021, from collaboration and license revenue from Roche, as compared to total revenue of $0.1 million for the first quarter of 2020, from collaboration revenue from Roche. Research and development (R&D) expenses totaled $21.1 million for the first quarter of 2021, as compared to $15.2 million for the first quarter of 2020. The increase in R&D expense for the first quarter of 2021 compared to the same period in the prior year was primarily due to higher R&D consulting expense, higher personnel expense, higher manufacturing expense primarily related to our PRX012 and birtamimab programs, higher clinical trial expense primarily related to birtamimab partially offset by lower PRX004 clinical trial expenses and higher collaboration expense with Roche related to the prasinezumab program. R&D expenses included non-cash share-based compensation expense of $2.0 million for the first quarter of 2021, as compared to $2.0 million for the first quarter of 2020. General and administrative (G&A) expenses totaled $11.1 million for the first quarter of 2021, as compared to $9.7 million for the first quarter of 2020. The increase in G&A expenses for the first quarter of 2021 compared to the same period in the prior year was primarily related to higher personnel expense and higher expense for our directors and officers insurance premium. G&A expenses included non-cash share-based compensation expense of $4.2 million for the first quarter of 2021, as compared to $3.5 million for the first quarter of 2020. Total non-cash share-based compensation expense was $6.2 million for the first quarter of 2021, as compared to $5.5 million for the first quarter of 2020. As of March 31, 2021, Prothena had $345.7 million in cash, cash equivalents and restricted cash (does not include the $60 million milestone earned in the second quarter from Roche) and no debt. As of May 4, 2021, Prothena had approximately 44.2 million ordinary shares outstanding. The Company continues to expect the full year 2021 net cash used in operating and investing activities to be $51 to $74 million, which includes receiving the $60 million milestone earned in the second quarter from Roche. The Company is updating its projected year end cash balance to approximately $316 million in cash, cash equivalents and restricted cash (midpoint) (versus prior guidance of $235 million) to include an additional $81 million in net proceeds primarily from the public offering in March. The estimated full year 2021 net cash used in operating and investing activities is primarily driven by an estimated net loss of $79 to $111 million, which includes an estimated $20 million of non-cash share-based compensation expense. About Prothena Prothena Corporation plc is a late-stage clinical company with a robust pipeline of novel investigational therapeutics built on protein dysregulation expertise with the potential to change the course of devastating rare peripheral amyloid and neurodegenerative diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis, Alzheimer’s disease, Parkinson’s disease and a number of other neurodegenerative diseases. For more information, please visit the Company’s website at www.prothena.com and follow the Company on Twitter @ProthenaCorp. Forward-looking Statements This press release contains forward-looking statements. These statements relate to, among other things, the sufficiency of our cash position to fund advancement of a broad pipeline; our goal of building a protein dysregulation platform; the treatment potential, designs, and proposed mechanisms of action of birtamimab, prasinezumab, PRX004, PRX005, and PRX012; plans for future clinical studies of birtamimab, prasinezumab, PRX004, PRX005, and PRX012; amounts we might receive under our collaborations with Roche and Bristol Myers Squibb; the expected timing of reporting data from prior clinical studies of birtamimab and the Phase 2 clinical study of prasinezumab; our anticipated net cash burn from operating and investing activities for 2021 and expected cash balance at the end of 2021; and our estimated net loss and non-cash share-based compensation expense for 2021. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to the effects on our business of the worldwide COVID-19 pandemic and the risks, uncertainties and other factors described in the “Risk Factors” sections of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 11, 2021, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. We undertake no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events, or changes in our expectations. PROTHENA CORPORATION PLCCONSOLIDATED STATEMENTS OF OPERATIONS(unaudited - amounts in thousands except per share data) Three Months EndedMarch 31, 2021 2020Collaboration revenue $110 $141 License revenue 50 — Total revenue 160 141 Operating expenses: Research and development 21,144 15,248 General and administrative 11,125 9,741 Total operating expenses 32,269 24,989 Loss from operations (32,109) (24,848)Other income, net 34 1,113 Loss before income taxes (32,075) (23,735)Provision for (benefit from) income taxes 4,660 (166)Net loss $(36,735) $(23,569)Basic and diluted net loss per share $(0.91) $(0.59)Shares used to compute basic and diluted net loss per share 40,250 39,909 PROTHENA CORPORATION PLCCONSOLIDATED BALANCE SHEETS(unaudited - amounts in thousands) March 31, December 31, 2021 2020Assets Cash and cash equivalents$342,993 $295,380 Accounts receivable1 15 Prepaid expenses and other current assets7,955 2,537 Restricted cash, current1,352 1,352 Total current assets352,301 299,284 Property and equipment, net2,295 2,551 Operating lease right-of-use assets16,411 17,811 Restricted cash, non-current1,352 1,352 Other non-current assets7,360 11,977 Total non-current assets27,418 33,691 Total assets$379,719 $332,975 Liabilities and Shareholders’ Equity Accrued research and development9,355 9,044 Lease liability, current5,617 5,512 Other current liabilities8,484 11,292 Total current liabilities23,456 25,848 Deferred revenue, non current110,242 110,242 Lease liability, non-current10,884 12,326 Other non-current liabilities553 553 Total non-current liabilities121,679 123,121 Total liabilities145,135 148,969 Total shareholders’ equity234,584 184,006 Total liabilities and shareholders’ equity$379,719 $332,975 Media and Investors:Jennifer Zibuda, Director, Investor Relations & Communications650-837-8535, jennifer.zibuda@prothena.com

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  • Prothena Receives $60M Milestone Payment After Parkinson's Candidate Moves Forward In Mid-Stage Study With Dosing

    Prothena Corporation plc (NASDAQ: PRTA) has dosed the first patient in the Phase 2b PADOVA study evaluating prasinezumab in patients with early Parkinson's disease. Prasinezumab is an anti-alpha synuclein antibody. The event has triggered a $60 million milestone to Prothena from its worldwide collaboration with Roche Holding AG (OTCMKTS: RHHBY). Prothena has previously received $75 million in payments from Roche as part of this collaboration. PADOVA is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of prasinezumab in patients with early Parkinson's disease who are on stable symptomatic medication. The study will enroll approximately 575 patients. The primary endpoint is time to meaningful progression on motor signs of the disease, as assessed by over 5 point increase from baseline in the Parkinson's Disease score. Price Action: PRTA shares closed 5% lower at $23.39 on Monday. See more from BenzingaClick here for options trades from BenzingaIndia Gives Emergency Use Nod To Roche-Regeneron's COVID-19 Antibody CocktailOncologic Drugs Adcomm Backs Merck's Keytruda, Roche's Tecentriq Accelerated Approvals In Bladder Cancer© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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  • Prothena Announces Achievement of $60 Million Milestone From Roche for First Patient Dosed in Phase 2b Study of Prasinezumab in Early Parkinson’s Disease

    DUBLIN, Ireland, May 10, 2021 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with a robust pipeline of novel investigational therapeutics built on protein dysregulation expertise, today announced that the Company has earned a $60 million milestone from its worldwide collaboration with Roche based on the first patient dosed in the Phase 2b PADOVA study of prasinezumab in patients with early Parkinson's disease. Prothena has previously received $75 million in payments from Roche as part of this collaboration. Prasinezumab is the first anti-alpha synuclein antibody to advance into late-stage clincal development. Results from the Phase 2 PASADENA study, reported in September 2020, demonstrated signals of efficacy on multiple pre-specified secondary and exploratory clinical endpoints, including measures of motor function and biomarkers, in patients with early Parkinson’s disease. These signals of efficacy add to the growing body of evidence that optimally targeting an appropriate epitope within pathogenic proteins, such as alpha-synuclein and abeta, results in clinically meaningful benefits for patients. Roche’s advancement of prasinezumab into this Phase 2b PADOVA study is an important step forward for this first-in-class compound, with the potential to slow the progression of Parkinson’s disease and positively impact the lives of millions of patients. Phase 2b PADOVA Study Design Based on positive signals of efficacy consistent with disease modification in the Phase 2 PASADENA study, prasinezumab is being advanced into the Phase 2b PADOVA study to further assess the efficacy and safety of prasinezumab in an expanded patient population. PADOVA is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of prasinezumab in patients with early Parkinson’s disease who are on stable symptomatic medication. The study will enroll approximately 575 patients, who will be randomized to receive either prasinezumab or placebo via intravenous infusion every 4 weeks. The primary endpoint is time to meaningful progression on motor signs of the disease, as assessed by ≥ 5 point increase from baseline in the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III score. For more information on the Phase 2b PADOVA study, please visit clinicaltrials.gov and search NCT # 04777331. About Parkinson's Disease Parkinson's disease is a progressive degenerative disorder of the entire nervous system that affects one in 100 people over age 60. An estimated seven to 10 million people are living with Parkinson's disease worldwide. It is the second most common neurodegenerative disorder after Alzheimer's disease. The disease is characterized by the neuronal accumulation of aggregated alpha-synuclein in the CNS and peripheral nervous system that results in a wide spectrum of worsening progressive motor and non-motor symptoms. While diagnosis relies on motor symptoms classically associated with Parkinson's disease, non-motor symptoms may present many years earlier. Current treatments for Parkinson's disease are symptomatic and only address a subset of symptoms such as motor impairment, dementia, or psychosis. There are currently no treatments available that target the underlying cause of the disease and can slow its progression. About Alpha-synuclein Alpha-synuclein, a protein found in neurons and other cells, is a major component of the pathology that characterizes several neurodegenerative disorders including Parkinson's disease, dementia with Lewy bodies, and multiple system atrophy, which collectively are termed synucleinopathies. The understanding of the normal physiological function of alpha-synuclein is limited, but evidence indicates that soluble forms of the protein may interact with other proteins and certain intracellular membranes. In synucleinopathies, the alpha-synuclein protein appears to be abnormally aggregated intracellularly, which contributes to disease pathology. There is increasing evidence that certain aggregated forms of alpha-synuclein can be transmitted from neuron to neuron, resulting in a propagation of pathology that causes neuronal dysfunction and loss. Recent studies in cellular and animal models of synucleinopathy suggest that the spread of alpha-synuclein-associated neuronal pathology can be disrupted by targeting aberrant forms of alpha-synuclein. About Prasinezumab Prasinezumab is a humanized monoclonal antibody that targets a carboxyl terminal epitope of alpha-synuclein, a protein found in neurons that can aggregate and spread from cell to cell, resulting in the neuronal dysfunction and loss that causes Parkinson’s disease. Prasinezumab is designed to block the cell-to-cell transmission of the aggregated, pathogenic forms of alpha-synuclein in Parkinson's disease, thereby slowing clinical decline. Prior to initiating clinical trials, the efficacy of prasinezumab was evaluated in various cellular and animal models of alpha-synuclein-related disease. In alpha-synuclein transgenic mice, the murine version of prasinezumab reduced the appearance of alpha-synuclein pathology, protected synapses and halted the worsening of behavioral phenotypes. In December 2013, Prothena and Roche entered into a worldwide collaboration to develop and commercialize antibodies that target alpha-synuclein, including prasinezumab. Prothena has an option to co-promote prasinezumab in the U.S., where the companies share all development and commercialization costs, as well as profits, on a 30/70 basis (30 percent Prothena, 70 percent Roche). Outside the U.S., Roche has sole responsibility for developing and commercializing prasinezumab and has agreed to pay Prothena up to double-digit royalties on net sales. To date, Prothena has received $75 million and earned an additional $60 million of a total potential $600 million in milestone payments that includes clinical, regulatory and sales milestones. For more information on the Phase 2 PASADENA clinical study of prasinezumab in patients with early Parkinson's disease, visit clinicaltrials.gov and search NCT #03100149. About Prothena Prothena Corporation plc is a late-stage clinical company with a robust pipeline of novel investigational therapeutics built on protein dysregulation expertise with the potential to change the course of devastating rare peripheral amyloid and neurodegenerative diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis, Alzheimer’s disease, Parkinson’s disease and a number of other neurodegenerative diseases. For more information, please visit the Company’s website at www.prothena.com and follow the Company on Twitter @ProthenaCorp. Forward-looking Statements This press release contains forward-looking statements. These statements relate to, among other things, the treatment potential, design, and proposed mechanism of action of prasinezumab; plans for the Phase 2b PADOVA clinical study of prasinezumab; and amounts we might receive under our collaboration with Roche. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to the effects on our business of the worldwide COVID-19 pandemic and the risks, uncertainties and other factors described in the “Risk Factors” sections of our Prospectus Supplement filed pursuant to Rule 424(b)5 with the Securities and Exchange Commission (SEC) on March 24, 2021, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. We undertake no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events or changes in our expectations. Contact: Jennifer Zibuda, Director, Investor Relations & Communications650-837-8535, jennifer.zibuda@prothena.com

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  • Drug/Biotech Stock Q1 Earnings on May 10: CPRX, PRTA & More

    Let us take a look at four small companies, CPRX, MYOV, PRTA, HRMY, which are gearing up for their earnings release.

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  • Prothena Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

    DUBLIN, Ireland, May 07, 2021 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with a robust pipeline of novel investigational therapeutics built on protein dysregulation expertise, today announced that in connection with hiring two new employees, the compensation committee of the Company’s board of directors granted the individuals hired by the Company, in the aggregate, options to purchase 155,000 ordinary shares of the Company. The options have an exercise price per share equal to $27.04, which was the closing trading price on May 3, 2021, the date of the grants. The inducement awards will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the date of grants and 1/48th of the underlying shares vesting monthly thereafter over 36 months. The options were granted pursuant to the Company’s 2020 Employment Inducement Incentive Plan, which was approved by the Company’s board of directors under Rule 5635(c)(4) of The Nasdaq Global Market for equity grants to induce new employees to enter into employment with the Company. About Prothena Prothena Corporation plc is a late-stage clinical company with a robust pipeline of novel investigational therapeutics built on protein dysregulation expertise with the potential to change the course of devastating rare peripheral amyloid and neurodegenerative diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis, Alzheimer’s disease, Parkinson’s disease and a number of other neurodegenerative diseases. For more information, please visit the Company’s website at www.prothena.com and follow the Company on Twitter @ProthenaCorp. Contacts: Media & InvestorsJennifer Zibuda, Director, Investor Relations & Communications650-837-8535, jennifer.zibuda@prothena.com

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  • Puma (PBYI) Beats on Q1 Earnings, Ups Nerlynx Sales View

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  • Prothena to Report First Quarter 2021 Financial Results on May 11th

    DUBLIN, Ireland, May 04, 2021 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with expertise in protein dysregulation and a pipeline of investigational therapeutics for rare peripheral amyloid and neurodegenerative diseases, announced today that it will report its first quarter 2021 financial results on Tuesday, May 11, 2021 after the close of the U.S. financial markets. Consistent with past practice, the Company will not be conducting a conference call in conjunction with this financial results release on May 11. About Prothena Prothena Corporation plc is a late-stage clinical company with expertise in protein dysregulation and a pipeline of novel investigational therapeutics with the potential to change the course of devastating rare peripheral amyloid and neurodegenerative diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis, Alzheimer’s disease, Parkinson’s disease and a number of other neurodegenerative diseases. For more information, please visit the Company’s website at www.prothena.com and follow the Company on Twitter @ProthenaCorp. Contacts: Media & InvestorsJennifer Zibuda, Director, Investor Relations & Communications650-837-8535, jennifer.zibuda@prothena.com

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  • Earnings Preview: Prothena (PRTA) Q1 Earnings Expected to Decline

    Prothena (PRTA) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

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  • Prothena Presents Phase 1 Study Results of PRX004 in Oral Presentation at AAN 2021

    Slowing of neuropathy progression for all 7 evaluable patients, evidenced by a +1.29 point mean change in NIS, was more favorable than expected progression of +9.2 pointsImprovement in neuropathy for 3 of these 7 evaluable patients demonstrated by a mean change in NIS of -3.33 points Improvement in cardiac function for all 7 evaluable patients demonstrated by a decrease in global longitudinal strain (GLS) Emerging Science Oral Presentation today at AAN 2021 DUBLIN, Ireland, April 18, 2021 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA) today presented positive results from the Phase 1 study of PRX004 as part of the Emerging Science Session at the American Academy of Neurology (AAN) 2021 Virtual Annual Meeting. PRX004 showed favorable results as demonstrated by slowing of neuropathy progression for all 7 evaluable patients at 9 months, including improvement in neuropathy in 3 of the 7 patients, and improved cardiac systolic function for all 7 patients. In this Phase 1 study, PRX004 was found to be generally safe and well tolerated across all dose levels. The positive results were presented by Dr. Ole Suhr, Senior Professor, Department of Public Health and Clinical Medicine, Umeå University, gastroenterologist and internist who was a principal investigator in the study and were previously highlighted by Prothena on December 9, 2020. For all of the evaluable patients, slowing of neuropathy progression was demonstrated by a mean change from baseline in Neuropathy Impairment Score (NIS) of +1.29 points at 9 months. This compares favorably to a calculated mean change in NIS of +9.2 points at 9 months in untreated and placebo-treated patients with hereditary ATTR peripheral neuropathy (hATTR-PN) based on analysis of published historical data. In addition, the change in NIS for each of these evaluable patients was more favorable than the published historical data. In this highly progressive disease, it was encouraging to see 3 of 7 patients demonstrate improvement in neuropathy with a mean change in NIS of –3.33 points at 9 months. These positive results were observed in patients with or without concomitant use of stabilizer therapy. PRX004 also demonstrated improvement in cardiac systolic function in each of the 7 evaluable patients, with a mean change in GLS of –1.21% at 9 months (centrally read). For the 3 patients who improved on NIS, GLS improvement was more pronounced, with a mean change of –1.51% at 9 months. Taken together, these positive clinical findings suggest PRX004’s depleter mechanism of action can result in benefits in both neuropathy and cardiac function. “I was pleased to see evidence of both a slowing of disease progression as well as a rapid improvement in neuropathy in some patients after only 9 months of treatment with PRX004. Given the expected clinical progression in these patients, the more favorable than expected change in NIS for all 7 patients is an encouraging finding, as is PRX004’s favorable safety and tolerability profile,” stated Ole Suhr, MD. “These results demonstrate the potential of PRX004’s depleter mechanism to provide a new treatment paradigm that is highly needed to treat patients at high risk of early mortality due to amyloid deposition in vital organs.” Today’s presentation at AAN 2021 will be made available on the Company’s website at www.prothena.com under the Investors tab in the Events and Presentations section. PRX004 Phase 1 Study The Phase 1, open-label, multicenter dose-escalation study (NCT03336580) enrolled 21 patients with hereditary ATTR Amyloidosis (hATTR) to receive PRX004 intravenously once every 28 days for up to 3 infusions in the dose escalation phase of the study. Patients were enrolled into 1 of the following 6 PRX004 dose cohorts: 0.1, 0.3, 1, 3, 10, and 30 mg/kg, starting with the lowest dose. Eligible patients who completed dose-escalation were provided the opportunity to enroll in the long-term extension (LTE) portion of the study. All 21 patients enrolled in the Phase 1 study successfully completed dose-escalation and 17 patients subsequently enrolled in the LTE. In order to inform dose selection, a pharmacokinetic/pharmacodynamic (PK/PD) model was developed and subsequently confirmed by observed reductions in free non-native TTR (transthyretin) in plasma of patients following PRX004 administration. Based on this model, dose levels ≥3 mg/kg were predicted to saturate (occupy ≥90%) amyloid deposits. Therefore, cohorts 4, 5 and 6 were considered equivalent, and efficacy was explored in these patients and pooled. Of the 12 patients in these cohorts, 7 patients (n=3 in cohort 4, n=3 in cohort 5 and n=1 in cohort 6) received all infusions through 9 months and were therefore considered evaluable for efficacy. The remaining 5 patients did not meet these criteria due to COVID-19 pandemic-related disruptions. PRX004 demonstrated a PK profile consistent with an lgG1 monoclonal antibody and exposures increased proportionally with dose. Monthly intravenous (IV) infusions of PRX004 were generally safe and well tolerated at all dose levels tested, with 233 separate infusions and up to 17 infusions per patient in the study. No drug-related serious adverse events (SAEs), drug-related ≥ grade 3 adverse events, deaths or dose-limiting toxicities were reported. The most frequent treatment-emergent AEs (≥10%) were fall, anemia, upper respiratory tract infection, back pain, constipation, diarrhea and insomnia. No clinically relevant anti-drug antibodies were observed. Consistent with the proposed mechanism of action, PRX004 administration did not impact levels of native, normal tetrameric TTR. About ATTR Amyloidosis Transthyretin amyloidosis (ATTR amyloidosis) is a rare, progressive and fatal disease characterized by deposition of abnormal, non-native forms of TTR protein (amyloid) in vital organs. ATTR amyloidosis can be hereditary (hATTR) when caused by a mutation in the TTR gene, or wild-type (wtATTR) when it occurs sporadically. Patients can experience a spectrum of clinical manifestations due to deposition of amyloid that can affect multiple organs, most commonly the heart and/or nervous system. It is estimated that between 400,000 to 1.4 million patients suffer from ATTR-cardiomyopathy (ATTR-CM). Within this population, between 130,000 to 490,000 patients are estimated to be moderate-to-advanced and categorized as New York Heart Association Class III and IV. TTR protein is produced primarily in the liver, pancreas and choroid plexus and in its native tetrameric form serves as a carrier for thyroxin and retinol binding protein (a transporter for vitamin A) and has been proposed to have neuroprotective effects. About PRX004 and Depleter Mechanism of Action PRX004 is an investigational humanized monoclonal antibody designed to deplete amyloid associated with disease pathology that underlies hereditary and wild type ATTR amyloidosis (hATTR and wtATTR, respectively), without affecting the native, normal tetrameric form of the protein. It is generally accepted that at the time of diagnosis, affected organs in ATTR patients contain extracellular amyloid deposits. These deposits, together with prefibrillar species, are believed to cause organ dysfunction. PRX004 has been shown in preclinical studies to promote clearance of insoluble amyloid fibrils through antibody-mediated phagocytosis and inhibit amyloid formation. This depleter mechanism of action has the potential to provide benefit for ATTR patients at high risk for early mortality due to amyloid deposition in vital organs. About Prothena Prothena Corporation plc is a late-stage clinical company with expertise in protein dysregulation and a pipeline of novel investigational therapeutics with the potential to change the course of devastating rare peripheral amyloid and neurodegenerative diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis, Alzheimer’s disease, Parkinson’s disease and a number of other neurodegenerative diseases. For more information, please visit the Company’s website at www.prothena.com and follow the Company on Twitter @ProthenaCorp. Forward-looking Statements This press release contains forward-looking statements. These statements relate to, among other things, the treatment potential, design and proposed mechanism of action of PRX004; and the design and capabilities of our misTTR assay for hereditary ATTR. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to the effects on our business of the worldwide COVID-19 pandemic and the risks, uncertainties and other factors described in the “Risk Factors” sections of our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 26, 2021, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. We undertake no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events or changes in our expectations. Contacts: Media:Ellen Rose, Head of Communications650-922-2405, ellen.rose@prothena.com Investors:Jennifer Zibuda, Director, Investor Relations & Communications650-837-8535, jennifer.zibuda@prothena.com

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  • Prothena Announces PRX004 Phase 1 Study Results Selected for Emerging Science Oral Presentation at AAN 2021

    DUBLIN, Ireland, April 15, 2021 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with expertise in protein dysregulation and a pipeline of investigational therapeutics for rare peripheral amyloid and neurodegenerative diseases, today announced that results from its Phase 1 study of PRX004 in ATTR amyloidosis have been selected for an oral presentation as part of the Emerging Science Session on Sunday, April 18th at the American Academy of Neurology (AAN) 2021 Virtual Annual Meeting. The results will be presented by Dr. Ole Suhr, Senior Professor, Department of Public Health and Clinical Medicine, Umeå University, a gastroenterologist and internist who was a principal investigator in the study. The positive results from this study were previously highlighted by Prothena in December 2020. “We are pleased to share these data that highlight the potential of PRX004’s novel depleter mechanism at the upcoming AAN conference,” commented Dr. Hideki Garren, Prothena’s Chief Medical Officer. “New therapies are needed to treat this deadly disease, especially for patients with more advanced ATTR cardiomyopathy who are at high risk of early mortality due to amyloid deposition, and we look forward to advancing PRX004 for these patients.” The oral presentation and Q&A are scheduled as follows: Session: Emerging Science SessionDate and Time: Sunday, April 18th, 3:00 – 4:30 PM Eastern TimeTitle and ID: Neurological and Cardiac Improvements with PRX004 in Amyloidosis Patients: Results of a Phase 1 Study (Session ID Number 70002) Data Presentation, 3:00 – 3:44 PMQ&A Breakout, 3:45 – 4:30 PM About Prothena Prothena Corporation plc is a late-stage clinical company with expertise in protein dysregulation and a pipeline of novel investigational therapeutics with the potential to change the course of devastating rare peripheral amyloid and neurodegenerative diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis, Alzheimer’s disease, Parkinson’s disease and a number of other neurodegenerative diseases. Contacts: MediaEllen Rose, Head of Communications650-922-2405, ellen.rose@prothena.com InvestorsJennifer Zibuda, Director, Investor Relations & Communications650-837-8535, jennifer.zibuda@prothena.com

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  • Prothena Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

    DUBLIN, Ireland, April 07, 2021 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with expertise in protein dysregulation and a pipeline of investigational therapeutics for rare peripheral amyloid and neurodegenerative diseases, today announced that in connection with hiring Dr. Hideki Garren as Prothena’s Chief Medical Officer, the compensation committee of the Company’s board of directors granted Dr. Garren, an option to purchase 250,000 ordinary shares of the Company. Such stock option has an exercise price per share equal to $24.90, which was the closing trading price on April 5, 2021, the date of the grant. In addition, in connection with hiring a new employee, the compensation committee of the Company’s board of directors granted the individual an option to purchase 30,000 ordinary shares of the Company. Such stock option has an exercise price per share equal to $24.74, which was the closing trading price on April 1, 2021, the date of the grant. The inducement awards will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the respective dates of the grants and 1/48th of the underlying shares vesting monthly thereafter over 36 months. The options were granted pursuant to the Company’s 2020 Employment Inducement Incentive Plan, which was approved by the Company’s board of directors under Rule 5635(c)(4) of The Nasdaq Global Market for equity grants to induce new employees to enter into employment with the Company. About Prothena Prothena Corporation plc is a late-stage clinical company with expertise in protein dysregulation and a pipeline of novel investigational therapeutics with the potential to change the course of devastating rare peripheral amyloid and neurodegenerative diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis, Alzheimer’s disease, Parkinson’s disease and a number of other neurodegenerative diseases. For more information, please visit the Company’s website at www.prothena.com and follow the Company on Twitter @ProthenaCorp. Contacts: MediaEllen Rose, Head of Communications650-922-2405, ellen.rose@prothena.com InvestorsJennifer Zibuda, Director, Investor Relations & Communications650-837-8535, jennifer.zibuda@prothena.com

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  • Prothena Announces Appointment of Hideki Garren, MD, PhD, as Chief Medical Officer

    Dr. Garren’s extensive expertise and successful track record of advancing neurology and rare disease programs through late-stage development, registration and launch supports Company’s transition to a fully-integrated R&D and commercial businessDUBLIN, Ireland, April 05, 2021 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with expertise in protein dysregulation and a pipeline of investigational therapeutics for rare peripheral amyloid and neurodegenerative diseases, today announced the appointment of Hideki Garren, MD, PhD, as Chief Medical Officer. Dr. Garren will lead the clinical and medical organizations to advance Prothena’s clinical pipeline. “Hideki brings valuable experience and expertise to our team as we look ahead towards transitioning to a fully integrated research, development and commercial biotechnology company,” said Gene Kinney, PhD, President and Chief Executive Officer. “His experience leading several late-stage development programs in neurology and rare disease indications through registration and launch is particularly relevant as we advance our pipeline of programs in these areas. We are delighted to welcome him to the team as we prepare for our next stage of growth.” “Prothena’s impressive scientific platform has advanced a rich pipeline of potentially transformational therapeutics, including several programs that have demonstrated benefit on meaningful clinical endpoints in diseases with highly significant unmet medical needs,” commented Dr. Garren. “I am excited to join the company during this dynamic period of growth and look forward to working as part of this exceptional team with a rich scientific heritage.” Dr. Garren joins Prothena from F. Hoffmann-La Roche Ltd. (Roche) & Genentech Inc. where he was Vice President, Global Head of Neuroimmunology, leading Roche’s Neuroimmunology franchise team. A neurologist by training, Dr. Garren was most recently responsible for the Phase 3 clinical programs for Ocrevus for Multiple Sclerosis and Enspryng for Neuromyelitis Optica Spectrum Disorder. Dr. Garren also held the role of Executive Director, Translational Medicine Expert in Neuroscience with Novartis Pharma. Prior to Novartis, Dr. Garren served as Co-Founder, Executive Vice President, Chief Scientific Officer, and Chief Operating Officer of Bayhill Therapeutics, Inc., a company he started in 2002 based on a technology platform he co-invented while at Stanford University. Dr. Garren earned his Bachelor of Science from the California Institute of Technology and his MD and PhD from the University of California, Los Angeles (UCLA). He completed his internship in internal medicine at UCLA, and his residency in neurology and fellowship in neuroimmunology at Stanford University. About Prothena Prothena Corporation plc is a late-stage clinical company with expertise in protein dysregulation and a pipeline of novel investigational therapeutics with the potential to change the course of devastating rare peripheral amyloid and neurodegenerative diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis, Alzheimer’s disease, Parkinson’s disease and a number of other neurodegenerative diseases. Contacts: MediaEllen Rose, Head of Communications650-922-2405, ellen.rose@prothena.com InvestorsJennifer Zibuda, Director, Investor Relations & Communications650-837-8535, jennifer.zibuda@prothena.com

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