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 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.
Avenue Therapeutics, Inc. (NASDAQ: ATXI) announced its financial results for Q2 2020, highlighting a cash position of $5.3 million, down from $6.6 million in Q1 2020. R&D expenses decreased significantly to $1.2 million from $6.4 million in Q2 2019, primarily due to the completion of studies. The net loss was $1.9 million, or $0.11 per share, improving from a net loss of $7.0 million, or $0.43 per share, year-over-year. Avenue is preparing for the PDUFA date for its IV tramadol on October 10, 2020, supported by recent positive publications of Phase 3 study results.
Avenue Therapeutics (NASDAQ: ATXI) announced the publication of Phase 3 study results for its IV tramadol, aimed at postoperative pain relief after bunionectomy. The study assessed 50 mg and 25 mg IV tramadol doses against a placebo. The 50 mg dose showed significant improvement in pain relief (p 0.05) over placebo across primary and secondary endpoints, with a high completion rate (98.6%). While 25 mg was well-tolerated, it was deemed ineffective. The results support further development of IV tramadol 50 mg in the ongoing Phase 3 program.
Avenue Therapeutics (NASDAQ: ATXI) announced significant progress in the development of intravenous tramadol for postoperative pain management. Recent publications highlight a Phase 3 study demonstrating that IV tramadol is statistically superior to placebo and comparable to IV morphine. Additionally, a safety study involving 251 patients indicated high tolerability of tramadol, with 95% reporting effective pain control. A third study noted a lower prevalence of oral tramadol misuse compared to traditional opioids. These findings support Avenue's mission to provide a safer pain management alternative.
Avenue Therapeutics (NASDAQ: ATXI) announced a virtual format for its 2020 Annual Meeting of Stockholders scheduled for June 16, 2020. This decision is due to COVID-19 health concerns and gathering restrictions. The meeting will start at 10:00 a.m. Eastern Time, and stockholders of record as of April 20, 2020, can vote online. Access to the meeting can be gained through the provided link, and technical support will be available from 9:45 a.m. on the meeting day. Avenue focuses on developing IV tramadol as an alternative to conventional opioids for acute pain management.
Avenue Therapeutics, Inc. (NASDAQ: ATXI) reported its financial results for Q1 2020, highlighting significant milestones in its IV tramadol development. The FDA accepted its New Drug Application with a PDUFA goal date set for October 10, 2020. Cash and cash equivalents as of March 31, 2020, decreased to $6.6 million from $8.7 million at year-end 2019. R&D expenses dropped to $0.7 million, down from $10.2 million due to study completions. The company’s net loss was $1.2 million, translating to $0.08 per share, a notable reduction from the previous year’s loss of $11.3 million.