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. (NASDAQ: ATXI), a subsidiary of Fortress Biotech (NASDAQ: FBIO), is a specialty pharmaceutical company headquartered in Miami, FL. Avenue focuses on developing and commercializing therapies for the treatment of neurologic diseases. The company's core product pipeline includes AJ201 for spinal and bulbar muscular atrophy (SBMA), BAER-101 for epilepsy and panic disorders, and IV tramadol for moderate-to-moderately-severe postoperative pain management. Avenue is currently engaged in a pivotal Phase 3 program for IV tramadol, which aims to fill a therapeutic gap in the acute pain market between IV acetaminophen/NSAIDs and conventional narcotics. AJ201, designed for SBMA or Kennedy’s Disease, is in the Phase 1b/2a clinical trial stage, with topline data expected in mid-2024. Additionally, BAER-101 has shown promising preclinical results in epilepsy models and is slated for further development contingent on financing. The company continues to advance its innovative drug pipeline while maintaining strategic partnerships and exploring new opportunities for growth in the pharmaceutical market. Recent achievements include completion of patient enrollment for AJ201’s Phase 1b/2a trial, FDA alignment on the Phase 3 safety study for IV tramadol, and multiple public equity offerings raising substantial gross proceeds. Avenue's commitment to providing impactful therapies to patients with unmet medical needs underscores its significance in the specialty pharmaceutical sector. For more information, visit www.avenuetx.com.
Avenue Therapeutics, Inc. (Nasdaq: ATXI), a specialty pharmaceutical company focused on neurologic diseases, will present a corporate update at the Aegis Capital Virtual Conference on May 4, 2023, at 4:00 p.m. EDT. CEO Alexandra MacLean will lead the presentation. Interested participants can access the zoom link on Avenue's website for 30 days post-event. Avenue is developing three key assets: AJ201 for spinal and bulbar muscular atrophy, BAER-101 for CNS diseases, and IV Tramadol, currently in Phase 3 clinical development for pain management. Founded by Fortress Biotech, Avenue Therapeutics is headquartered in Miami, FL.
Avenue Therapeutics, Inc. (Nasdaq: ATXI) has received official meeting minutes from the FDA following a Type C meeting on March 9, 2023, regarding the development of IV Tramadol for post-operative pain management. The FDA agreed on most aspects of the proposed study protocol, addressing the risk of opioid-induced respiratory depression compared to IV morphine. This follows earlier discussions in August 2022, where the FDA found the proposed study design reasonable. Avenue aims to finalize the protocol based on FDA feedback, with plans to initiate a Phase 3 safety study in 2023. A successful trial outcome could pave the way for IV Tramadol's approval. Avenue also plans to update on its additional programs targeting spinal muscular atrophy and epilepsy later this year.
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