Welcome to our dedicated page for Avenue Therapeutics news (Ticker: ATXI), a resource for investors and traders seeking the latest updates and insights on Avenue Therapeutics stock.
Avenue Therapeutics, Inc. (ATXI) generates a steady flow of news as a specialty pharmaceutical company focused on the development and commercialization of therapies for neurologic diseases. Company announcements highlight progress across its clinical pipeline, corporate transactions, financing activities, and stock listing matters, providing context for investors and followers of the neurologic drug development space.
News coverage commonly features clinical development updates for AJ201, Avenue’s first-in-class asset in development for spinal and bulbar muscular atrophy (SBMA). Releases describe milestones such as completion of last patient visits in a Phase 1b/2a trial, anticipated topline data timing, and details on trial design, endpoints, and biomarker strategies in SBMA, also known as Kennedy’s disease.
Another frequent topic is BAER-101, an oral small molecule selective GABAA α2, α3 receptor positive allosteric modulator for CNS diseases. Avenue has reported preclinical data demonstrating seizure suppression in epilepsy models, presented at scientific meetings and in peer-reviewed publications. Later news and SEC filings describe the acquisition of Avenue’s majority-owned subsidiary Baergic Bio, Inc. by Axsome Therapeutics, under which Axsome obtained worldwide rights to BAER-101 (AXS-17) and Avenue became eligible for potential milestone and royalty payments.
News items also address IV tramadol, including Avenue’s agreement with the U.S. Food and Drug Administration on a Phase 3 safety study protocol for acute postoperative pain in adults in a medically supervised setting. In addition, Avenue regularly reports on quarterly financial results, warrant exercise transactions, reverse stock split actions, participation in healthcare and investor conferences, and developments related to its stock exchange listing status.
Investors and observers who follow ATXI news can track how Avenue describes the evolution of its neurologic disease pipeline, its strategic transactions such as the Baergic/BAER-101 deal, and its efforts to secure financing and maintain public listing compliance. This news page brings together these company-issued updates in one place for ongoing reference.
Avenue Therapeutics, Inc. (NASDAQ:ATXI) successfully completed a $12 million underwritten public offering, with Aegis Capital Corp. serving as the sole bookrunner on October 12, 2022. The funds raised will support the company's development of intravenous Tramadol, a dual-acting opioid currently in Phase III trials for treating post-operative acute pain. Avenue Therapeutics focuses on specialty pharmaceuticals for acute care settings and was incorporated in 2015.
Avenue Therapeutics, Inc. (Nasdaq: ATXI) announced the closing of its public offering of 3,636,365 common and pre-funded units at a price of $3.30 per unit, raising approximately $10.4 million after expenses. The capital will be used to repurchase shares held by InvaGen Pharmaceuticals Inc. and for general corporate purposes, including drug development. An additional 545,454 warrants were sold via an over-allotment option. Aegis Capital Corp. managed the offering, with all operations in compliance with SEC regulations.
Avenue Therapeutics (Nasdaq: ATXI) has priced an underwritten public offering of 3,636,365 common and pre-funded units, each at $3.30 per common unit, aiming for gross proceeds of approximately $13.8 million if the underwriter's over-allotment option is fully exercised. The offering is set to close on October 11, 2022. Proceeds will be used to repurchase shares held by InvaGen Pharmaceuticals and fund general corporate purposes, including drug development. The SEC declared the related registration statement effective on October 6, 2022.
Avenue Therapeutics (Nasdaq: ATXI) announced a 1-for-15 reverse stock split effective September 23, 2022. Approved by shareholders, the split aims to comply with Nasdaq's $1.00 minimum bid price requirement. Post-split, outstanding shares will decrease from approximately 22.7 million to about 1.5 million. Additionally, Avenue discussed regulatory updates regarding its intravenous Tramadol product, receiving positive feedback from the FDA on a proposed safety study design to mitigate risks associated with opioid stacking. The company plans to submit a detailed protocol based on FDA suggestions.
Avenue Therapeutics (NASDAQ: ATXI) announced the outcome of the FDA joint meeting concerning its IV tramadol development for acute pain management. The Advisory Committee voted 8-14 against whether the benefits of IV tramadol outweigh its risks in inpatient settings. The FDA requires this input for a decision on Avenue's formal dispute resolution request, expected within 30 days. Avenue aims to provide an alternative to conventional opioids for acute pain relief in the U.S.
Avenue Therapeutics announced that the FDA Advisory Committee will review the New Drug Application for IV tramadol on February 15, 2022. The meeting will involve the Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management Committees. This review is crucial as it influences the Office of New Drugs' decision regarding Avenue's formal dispute resolution request. Trading of Avenue's stock on NASDAQ has been suspended pending this event.
Avenue Therapeutics has successfully completed a $2 million public offering of common stock, with Aegis Capital Corp. acting as the sole bookrunner. The funds raised will support the company’s ongoing development of IV tramadol, an alternative aimed at reducing opioid use for patients with acute pain in the U.S. Avenue Therapeutics is headquartered in New York City and is focused on innovative solutions for pain management.
Avenue Therapeutics (NASDAQ: ATXI) has successfully closed its public offering of 1,910,100 shares of common stock at a price of $1.07, raising approximately $2.0 million in gross proceeds. Aegis Capital Corp. acted as the sole book-running manager for this offering and has a 45-day option to purchase an additional 286,430 shares to cover over-allotments. The registration statement for the offering was declared effective by the SEC on December 10, 2021. Avenue Therapeutics aims to develop IV tramadol as a potential alternative to conventional opioids for acute pain management.
Avenue Therapeutics (NASDAQ: ATXI) announced a public offering priced at $1.07 per share, aiming for gross proceeds of approximately $2.0 million. The offering will consist of 1,910,100 shares and is set to close on December 15, 2021, pending typical closing conditions. With a 45-day underwriters' option, the total could reach up to $2.3 million. The net proceeds will support working capital and corporate purposes. Avenue specializes in developing intravenous tramadol as an alternative to opioids for acute pain management in the U.S.
Avenue Therapeutics (NASDAQ: ATXI) announced that the FDA has tentatively scheduled a joint meeting for February 15, 2022, involving the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The meeting will address the New Drug Application for intravenous tramadol. The FDA previously indicated that this committee input is essential for the Office of New Drugs to make a decision regarding Avenue's formal dispute resolution request, with a response due within 30 days post-meeting.
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