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 (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.
Avenue Therapeutics (NASDAQ: ATXI) announced the full exercise of an underwriter’s option to purchase an additional 292,018 shares of common stock at $1.34 per share. This action brings total gross proceeds from the public offering to approximately $3 million, before expenses. The offering was conducted under a registration statement declared effective by the SEC. Avenue Therapeutics focuses on developing IV tramadol as an alternative to conventional opioids for acute pain management.
Aegis Capital Corp. has successfully completed a $2.6 million public offering of common stock for Avenue Therapeutics (NASDAQ: ATXI). The funds raised through this offering are aimed at advancing Avenue's mission to develop IV tramadol, a potential alternative to conventional opioids for acute pain management in the U.S. Avenue Therapeutics was founded by Fortress Biotech (NASDAQ: FBIO) and is positioned to address the growing need for effective pain relief solutions.
Avenue Therapeutics (NASDAQ: ATXI) has successfully concluded a public offering of 1,946,787 shares at a price of $1.34 per share, generating approximately $2.6 million in gross proceeds. The offering includes a 45-day option for Aegis Capital Corp. to buy an additional 292,018 shares. This funding aims to support the development of intravenous tramadol, intended as a safer alternative for acute pain management. Avenue Therapeutics is committed to mitigating opioid reliance in the U.S.
Avenue Therapeutics (NASDAQ: ATXI) announced the pricing of a public offering, aiming to raise approximately $2.6 million before expenses. The offering consists of 1,946,787 shares priced at $1.34 each, intended for working capital and corporate purposes. An additional 15% over-allotment option could increase gross proceeds to around $3 million. The closing of the offering is anticipated on November 12, 2021, pending standard conditions. Aegis Capital Corp. is the sole book-running manager for this offering.
Avenue Therapeutics (NASDAQ: ATXI) announced on October 25, 2021, that the FDA's Office of New Drugs requires additional input before deciding on the Formal Dispute Resolution Request regarding its intravenous tramadol. The FDA plans to hold an Advisory Committee meeting to gather advice from both the Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management Committees. A response to the FDRR is anticipated within 30 days after the meeting.
Avenue Therapeutics (NASDAQ: ATXI) announced it received a second Complete Response Letter (CRL) from the FDA regarding its New Drug Application for intravenous tramadol. The FDA cited that the unpredictable onset of analgesia does not support its use as monotherapy for acute pain and questioned its safety and efficacy with other analgesics. Avenue disagrees with the FDA's interpretation and plans to pursue regulatory approval.
Avenue Therapeutics announced that the FDA has not yet provided a decision on the New Drug Application (NDA) for IV tramadol. An acknowledgment letter from the FDA confirmed the resubmission was complete, with a PDUFA goal date set for April 12, 2021. The NDA resubmission followed a Complete Response Letter issued in October 2020, and included revised product labeling and sterilization reports. The company aims to develop IV tramadol as a potentially reduced risk alternative to traditional opioids for acute pain management.
Avenue Therapeutics, Inc. (NASDAQ: ATXI) announced the release of a publication analyzing tramadol misuse in four European countries in the journal Drug and Alcohol Dependence. This study, involving 45,000 responses, concluded that tramadol has a low rate of misuse compared to conventional opioids. Even with IV tramadol's availability, misuse via injection is rare. The research aims to understand tramadol's potential as a safer alternative to conventional opioids for acute pain management in the U.S.
Avenue Therapeutics (NASDAQ: ATXI) has announced the publication of a study on the nonmedical use (NMU) of tramadol versus other opioids, revealing tramadol's lower rates of NMU and diversion. Published in Drug Safety, the study, which analyzed data from 2010 to 2018, found tramadol to have significantly less abuse potential compared to morphine, oxycodone, and hydrocodone. This supports prior assessments by WHO and the U.S. Drug Enforcement Agency regarding tramadol's low potential for misuse. Avenue aims to develop IV tramadol as a safer alternative for acute pain management in the U.S.