Avenue Therapeutics, Inc. - ATXI STOCK NEWS

Avenue Therapeutics CEO to present corporate update at H.C. Wainwright conference

Avenue Therapeutics reports progress in clinical trials and agreement with FDA on study design for IV tramadol. First patient dosed in Phase 1b/2a trial of AJ201 for SBMA. Positive preclinical data for BAER-101 in epilepsy. Financial results show decrease in cash and increase in expenses.

Avenue Therapeutics announces positive preclinical results for BAER-101 in epilepsy treatment

Avenue Therapeutics announces the dosing of the first patient in the Phase 1b/2a clinical trial of AJ201 for the treatment of SBMA. The trial is expected to be completed by the end of 2023 or early 2024, with potential topline data in 2024.

Avenue Therapeutics has reached an agreement with the FDA on key elements of the Phase 3 safety study for its intravenous tramadol, which is being developed for the treatment of acute post-operative pain. The study will assess the risk of opioid-induced respiratory depression compared to IV morphine. The company believes that IV tramadol will prove to be safe and effective based on its mechanism of action and positive data from previous trials.

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.

Avenue Therapeutics (Nasdaq: ATXI) reported its financial results for 2022, demonstrating a strategic shift to focus on neurologic diseases with in-licensing of AJ201, currently in a Phase 1b/2a trial for Spinal and Bulbar Muscular Atrophy (SBMA). The company completed a $12 million public offering and had cash reserves of $6.7 million as of year-end, an increase from $3.8 million in 2021. R&D expenses rose to $2.7 million from $1.3 million, and the net loss attributable to stockholders was $3.6 million, or $1.63 per share. The CEO expressed optimism about the therapeutic potential of AJ201 and ongoing development of IV Tramadol and BAER-101.