Avenue Therapeutics, Inc. - ATXI STOCK NEWS

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.

Avenue Therapeutics (NASDAQ: ATXI) announced plans to resubmit its New Drug Application (NDA) for intravenous (IV) tramadol to the FDA in February 2021, following a Type A meeting. This meeting was held to discuss a Complete Response Letter received regarding the NDA. The resubmission will include revised product label language and a terminal sterilization validation report. Avenue aims to position IV tramadol as an alternative for acute pain management, potentially reducing dependence on conventional opioids. The company is based in New York City.

Avenue Therapeutics (NASDAQ: ATXI) has received a Complete Response Letter (CRL) from the FDA concerning its New Drug Application (NDA) for intravenous tramadol, intended for acute pain management. While Phase 3 trials showed significant efficacy, the FDA cited safety concerns regarding the potential need for rescue analgesics, which may lead to opioid stacking risks. Additionally, the FDA noted the requirement for adequate terminal sterilization validation. Avenue's CEO expressed confidence in IV tramadol's safety and plans to meet with the FDA to address these issues.

Avenue Therapeutics, Inc. (NASDAQ: ATXI) announced the publication of a peer-reviewed paper on IV tramadol in the Journal of Opioid Management, outlining its pharmacokinetics, abuse potential, and clinical safety. The review indicated that IV tramadol presents a lower abuse potential compared to oral tramadol and other opioids. It also suggested that IV tramadol's safety profile is comparable to oral tramadol. This development could offer U.S. clinicians a viable option for treating acute pain, potentially reducing reliance on traditional opioids.