Trading in Avenue Therapeutics shares halted today | Your money

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NEW YORK, Feb. 15 10, 2022 (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 NASDAQ halted trading in the company’s common stock.

Joint Meeting of the Anesthetic and Analgesic Drug Advisory Committee and the U.S. Food and Drug Administration (“FDA”) Drug Safety and Risk Management Advisory Committee Meets to Review New Drug Application from the company for tramadol IV.

The advisory committee meeting is scheduled for Tuesday, February 15, 2022, from 9:30 a.m. to 5 p.m. ET. Disclosure documents can be found on the FDA website here.

FDA Advisory Committees provide the FDA with independent advice and non-binding recommendations. The FDA has previously stated that input from an advisory committee is necessary for the Office of New Drugs (“OND”) to make a decision on Avenue’s formal Dispute Resolution (“FDRR”) request and that the OND will respond to Avenue’s FDRR within 30 years. calendar days after the advisory committee meeting.

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 with acute pain in the United States. Avenue is headquartered in New York. For more information, visit www.avenuetx.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, all 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 adversely affect our business, results of operations, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to obtaining FDA regulatory approval for our product candidate, risks related to the outbreak of COVID-19 and its potential impact on the ability of our employees and consultants to complete work in a timely manner, risks related to our growth strategy; risks related to the results of research and development activities; risks relating to the timing of the start and completion of clinical trials; our ability to obtain, execute and maintain financing and strategic agreements and relationships; uncertainties related to preclinical and clinical trials; our reliance on third-party vendors; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patents and intellectual property; competetion; and other risks described in our filings with the SEC. We expressly disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based, except if required by law, and we claim safe harbor protection for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Contacts: Jaclyn Jaffe and Bill Begien Avenue Therapeutics, Inc. (781) 652-4500 [email protected]


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