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ATXI

Avenue Therapeutics, Inc. Common Stock NASDAQ Capital Market
$4.28
Open: $4.22 High: $4.27 Low: $3.965 Close: $4.27
Range: 2021-05-06 - 2021-05-07
Volume: 121,685
Market: Closed
Powered by Finage Stock APIDelayed data
ATXI
Avenue Therapeutics, Inc. Common Stock 2 Gansevoort Street New York NY, 10014 http://www.avenuetx.com
Avenue Therapeutics Inc is a specialty pharmaceutical company focused on the development and commercialization of an intravenous, or IV, formulation of tramadol HCl, or IV Tramadol, for the management of moderate to moderately severe postoperative pain.
  • CEO: Lucy Lu
  • Employees: 2
  • Sector: Healthcare
  • Industry: Drug Manufacturers
ATXI News
Latest news about the ATXI
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  • SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Avenue Therapeutics, Inc. - ATXI

    NEW YORK, April 23, 2021 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Avenue Therapeutics Inc. (“Avenue” or the “Company”) (NASDAQ: ATXI). Such investors are advised to contact Robert S. Willoughby at newaction@pomlaw.com or 888-476-6529, ext. 7980. The investigation concerns whether Avenue and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On April 13, 2021, Avenue issued a press release “announc[ing] that the U.S. Food and Drug Administration (‘FDA’) was still reviewing its New Drug Application (‘NDA’) for IV tramadol and had not provided a decision regarding the NDA.” The Company’s resubmitted NDA for the treatment, which followed a complete response letter from the FDA in 2020, had been assigned an action date of April 12, 2021. On this news, Avenue’s stock price fell $1.69 per share, or 23.77%, on April 13, 2021. The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com CONTACT:Robert S. WilloughbyPomerantz LLPrswilloughby@pomlaw.com

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  • Avenue Therapeutics (ATXI) Sees Hammer Chart Pattern: Time to Buy?

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  • Why Fortress Biotech Stock Is Sinking Today

    What happened? Shares of biopharmaceutical company Fortress Biotech (NASDAQ: FBIO) are dropping sharply on Tuesday after the company announced a regulatory update regarding one of its subsidiaries, Avenue Therapeutics (NASDAQ: ATXI).

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  • Bronstein, Gewirtz & Grossman, LLC Notifies Investors of Avenue Therapeutics, Inc. (ATXI) Investigation

    NEW YORK, NY / ACCESSWIRE / April 13, 2021 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Avenue Therapeutics, Inc. ("Avenue" or "the Company") (NASDAQ:ATXI).

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  • Avenue Therapeutics Announces that the FDA is Still Reviewing Its NDA Resubmission for IV Tramadol

    The FDA Has Not Provided a Decision Regarding the NDANEW YORK, April 13, 2021 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, today announced that the U.S. Food and Drug Administration (“FDA”) was still reviewing its New Drug Application (“NDA”) for IV tramadol and had not provided a decision regarding the NDA. An acknowledgement letter from the FDA in February 2021 stated that the Company’s resubmission of its NDA for IV tramadol was a complete, class 1 response to the Complete Response Letter (“CRL”) dated October 9, 2020 and the resubmission had been assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of April 12, 2021. The NDA for IV tramadol was resubmitted following the receipt of official minutes from a Type A meeting with the FDA, which was conducted following a CRL issued by the FDA in October 2020. The resubmission package included revised language relating to the proposed product label and a report relating to terminal sterilization validation. About Avenue TherapeuticsAvenue Therapeutics is a specialty pharmaceutical company whose mission is to develop IV tramadol, a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S. Avenue is headquartered in New York City and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit www.avenuetx.com. About Fortress Biotech Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company that was ranked in Deloitte’s 2019 and 2020 Technology Fast 500™, annual rankings of the fastest-growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors, based on percentages of fiscal year revenue growth over three-year periods. Fortress is focused on acquiring, developing and commercializing high-potential marketed and development-stage drugs and drug candidates. The company has seven marketed prescription pharmaceutical products and over 25 programs in development at Fortress, at its majority-owned and majority-controlled partners and at partners it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases and gene therapy, which allow it to create value for shareholders. Fortress advances its diversified pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is driven by a world-class business development team that is focused on leveraging its significant biopharmaceutical industry expertise to further expand the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including Alexion Pharmaceuticals, Inc., AstraZeneca, City of Hope, Fred Hutchinson Cancer Research Center, St. Jude Children’s Research Hospital and Nationwide Children’s Hospital. For more information, visit www.fortressbiotech.com. Forward-Looking StatementsThis press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to us obtaining regulatory approval from the FDA for our product candidate; risk that our contingent acquisition by InvaGen Pharmaceuticals is not consummated, or that a dispute involving such transaction arises; risks relating to the COVID-19 outbreak and its potential impact on our employees’ and consultants’ ability to complete work in a timely manner; risks relating to our growth strategy; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Contacts: Jaclyn Jaffe and Bill BegienAvenue Therapeutics, Inc.(781) 652-4500ir@avenuetx.com

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  • Is Avenue Therapeutics (NASDAQ:ATXI) In A Good Position To Deliver On Growth Plans?

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  • How Much Of Avenue Therapeutics, Inc. (NASDAQ:ATXI) Do Institutions Own?

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  • Is Avenue Therapeutics (ATXI) Stock a Buy For 2021?

    Clark Street Value sold 2/3rds of its position in Avenue Therapeutics Inc. (NASDAQ:ATXI) stock. Clark Street Value is an individual investor that is focused on finding value and special situation investments. Avenue Therapeutics Inc. (NASDAQ:ATXI) is a pharmaceutical company. In the last one year, Avenue Therapeutics Inc. (NASDAQ:ATXI) stock lost 31.1% and on January 5th […]

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  • Avenue Therapeutics Announces Publication of Real-World Data on Nonmedical Use of Tramadol in ASI-MV Network

    NEW YORK, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (Avenue), a company focused on the development of intravenous (IV) tramadol for the U.S. market, today announced that a publication titled “Real-World Data on Nonmedical Use of Tramadol from Patients Evaluated for Substance Abuse Treatment in the NAVIPPRO Addiction Severity Index‒Multimedia Version (ASI-MV®) Network” has been published in Drug Safety, a peer-reviewed international journal covering pharmacoepidemiology and pharmacovigilance. The publication can be accessed here. “Utilization of real-world data adds significant value to the post market benefit-risk evaluation of prescription opioid medications, because comparative rates of nonmedical use (NMU) between prescription opioid compounds can help providers and patients with pain management decision making, balancing the need for pain therapy with potential risk of NMU,” commented Jody L. Green, Ph.D., the paper’s lead author and Chief Scientific Officer for Inflexxion, a division of Integrated Behavioral Health. “Compared to other common opioid compounds, tramadol had significantly lower rates of NMU, non-oral routes of administration such as snorting or injecting, and diversion, suggesting a lower abuse potential.”The objective of the study was to evaluate nonmedical use (NMU) and diversion of tramadol and comparator opioids (morphine, oxycodone, and hydrocodone) using real-world data from the Addiction Severity Index‒Multimedia Version (ASI-MV®). A cross-sectional study design was used to evaluate past 30-day tramadol and comparator opioid NMU among adults assessed for substance abuse treatment using the ASI-MV from 2010-2018. The paper concluded that tramadol had a significantly lower rate of NMU than comparator opioids and was less likely to be diverted or used via higher-risk non-oral routes, and that these findings support previous evaluations by WHO and the United States Drug Enforcement Agency that concluded that tramadol has a low potential for abuse.About Avenue Therapeutics Avenue Therapeutics is a specialty pharmaceutical company whose mission is to develop IV tramadol, a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S. Avenue is headquartered in New York City and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit www.avenuetx.com.About Inflexxion and Integrated Behavioral Health Inflexxion joined the Integrated Behavioral Health (IBH) family of companies in July 2018. Inflexxion is a healthcare data and analytics company that specializes in the collection, surveillance, monitoring and analysis of critical public health issues including prescription drug abuse, substance use, behavioral health, and pain management. With over 30 years in the industry, Inflexxion works with healthcare organizations, medical professionals, pharmaceutical companies, and regulatory authorities to assess, track and improve patient care and inform public policy. Inflexxion collects, analyzes and disseminates extensive behavior and health-related data for pharmaceutical post-market surveillance, risk management, epidemiological studies, product improvements, abuse prevention and outcome measurement.About Addiction Severity Index‒Multimedia Version (ASI-MV) The ASI-MV is a comprehensive, evidence-based, patient self-administered assessment tool. Based on the widely used Addiction Severity Index (ASI), the ASI-MV provides clinical information, severity ratings and composite scores in seven life domains: medical; employment; alcohol; drug; legal; family/social; and psychological. Behavioral health professionals use the ASI-MV to conduct standardized, thorough, and efficient substance-use assessments and to gather real-time data on client outcomes.Forward-Looking Statements This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to us obtaining regulatory approval from the FDA for our product candidate, risks relating to the COVID-19 outbreak and its potential impact on our employees’ and consultants’ ability to complete work in a timely manner, risks relating to our growth strategy; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.Contacts: Jaclyn Jaffe and William Begien Avenue Therapeutics, Inc. (781) 652-4500 ir@avenuetx.com

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  • Avenue Therapeutics Announces Publication of Tramadol Non-Medical Use in Four European Countries: A Comparative Analysis

    NEW YORK, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (Avenue), a company focused on the development of intravenous (IV) tramadol for the U.S. market, today announced that a publication titled “Tramadol Non-Medical Use in Four European Countries: A Comparative Analysis” has been published in Drug and Alcohol Dependence, a peer-reviewed international journal devoted to research, reviews, commentaries, and policy analyses in the area of drug, alcohol and tobacco use and dependence. The publication can be accessed here. “The goal of the study is to better understand the misuse and abuse of tramadol in countries where parenteral tramadol is available, which requires consistent measures of misuse behaviors and prevalence between countries. We evaluated tramadol compared to conventional opioids by utilizing a harmonized validated national survey across four countries: Germany, Italy, Spain, and the United Kingdom (UK),” commented Janetta L. Iwanicki, M.D., the paper’s lead author and Scientific Director of Research, Rocky Mountain Poison & Drug Safety. “Despite high availability, tramadol has a low rate of misuse and abuse in the four countries. Importantly, consistent with previous literature, misuse of tramadol by injection, an important marker of risk behavior, is rare in these countries.”In this study, data from the RADARS® System’s Survey of Non-Medical Use of Prescription Drugs (NMURx) Program online cross-sectional general population national surveys are analyzed from 2018 from four countries, Germany, Italy, Spain, and the UK, with 45,000 total responses. Misuse and abuse of tramadol, codeine, morphine, and oxycodone are compared, with national prevalence estimates calculated via calibration weighting. Rates are calculated per population and per drug availability with supplemental data included from patients entering treatment centers and poison center exposures. The paper concluded that tramadol misuse and abuse are infrequent both in absolute number of cases and in comparison to conventional opioids, and that, even with availability of intravenous tramadol formulations, misuse by injection is rare.About Avenue Therapeutics Avenue Therapeutics is a specialty pharmaceutical company whose mission is to develop IV tramadol, a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S. Avenue is headquartered in New York City and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit www.avenuetx.com.About Rocky Mountain Poison & Drug Safety Rocky Mountain Poison & Drug Safety provides specialized services spanning the lifecycle of a drug or consumer product to public health, government agencies, and the pharmaceutical and consumer products industries. Rocky Mountain Poison & Drug Safety’s Poison Center & Health Information and Drug & Consumer Product Services groups provide 24/7/365 contact center communication, exposure management, and toxicology consulting. Rocky Mountain Poison & Drug Safety offers research, analysis and surveillance, and consulting through its Research & Consulting Services group, including its industry-leading RADARS® system. For more information visit http://www.rmpds.org.About RADARS® System The RADARS System is supported by subscriptions from pharmaceutical manufacturers, government and non-government agencies for surveillance, research and reporting services. RADARS System is the property of Denver Health and Hospital Authority, a political subdivision of the State of Colorado. Denver Health retains exclusive ownership of all data, databases and systems. Subscribers do not participate in data collection nor do they have access to the raw data.Forward-Looking Statements This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to us obtaining regulatory approval from the FDA for our product candidate, risks relating to the COVID-19 outbreak and its potential impact on our employees’ and consultants’ ability to complete work in a timely manner, risks relating to our growth strategy; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.Contacts: Jaclyn Jaffe and William Begien Avenue Therapeutics, Inc. (781) 652-4500 ir@avenuetx.com

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  • Why Fortress Biotech Stock Jumped Today

    What happened? Shares of Fortress Biotech (NASDAQ: FBIO) soared on Thursday and closed the day's trading session up by 16.7%. The catalyst for these nice gains was a regulatory update from Avenue Therapeutics (NASDAQ: ATXI), a subsidiary of Fortress Biotech.

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  • Avenue Therapeutics Provides Regulatory Update for IV Tramadol

    Company Anticipates NDA Resubmission in February 2021NEW YORK, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (Avenue), a company focused on the development of intravenous (IV) tramadol for the U.S. market, today provided a regulatory update following receipt of the official meeting minutes from a November 2020 Type A meeting with the U.S. Food and Drug Administration (FDA) relating to a path forward for IV tramadol. Avenue had requested this Type A meeting to address a Complete Response Letter (CRL) it received from the FDA regarding the New Drug Application (NDA) for IV tramadol. Avenue intends to resubmit the NDA in February 2021, barring any Covid-19 related or other setbacks. The NDA resubmission will incorporate revised language relating to the proposed product label and a report relating to terminal sterilization validation.About Avenue Therapeutics Avenue Therapeutics is a specialty pharmaceutical company whose mission is to develop IV tramadol, a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S. Avenue is headquartered in New York City and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit www.avenuetx.com.About Fortress Biotech Fortress Biotech, Inc. (Fortress) is an innovative biopharmaceutical company that was ranked in Deloitte’s 2019 and 2020 Technology Fast 500™, annual rankings of the fastest-growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors, based on percentages of fiscal year revenue growth over three-year periods. Fortress is focused on acquiring, developing and commercializing high-potential marketed and development-stage pharmaceutical products and product candidates. The company has five marketed prescription pharmaceutical products and over 25 programs in development at Fortress, at its majority-owned and majority-controlled partners and at partners it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases and gene therapy, which allow it to create value for shareholders. Fortress advances its diversified pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is driven by a world-class business development team that is focused on leveraging its significant biopharmaceutical industry expertise to further expand the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including Alexion Pharmaceuticals, Inc., AstraZeneca, City of Hope, Fred Hutchinson Cancer Research Center, InvaGen Pharmaceuticals Inc. (a subsidiary of Cipla Limited), St. Jude Children’s Research Hospital and Nationwide Children’s Hospital. For more information, visit www.fortressbiotech.com.Forward-Looking Statements This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to us obtaining regulatory approval from the FDA for our product candidate, risks relating to the Covid-19 outbreak and its potential impact on our employees’ and consultants’ ability to complete work in a timely manner, risks relating to our growth strategy; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.Contacts: Jaclyn Jaffe and William Begien Avenue Therapeutics, Inc. (781) 652-4500 ir@avenuetx.com

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  • Read This Before Selling Avenue Therapeutics, Inc. (NASDAQ:ATXI) Shares

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