Avenue Therapeutics (ATXI) Stock News

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.

AnnJi Pharmaceutical has entered an exclusive licensing agreement with Avenue Therapeutics (ATXI) to develop AJ201 for spinal and bulbar muscular atrophy (SBMA) in multiple regions, including the U.S., Canada, EU, Great Britain, and Israel. The deal includes an upfront payment of $3 million and potential milestone payments of up to $250 million, plus royalties from net sales. Avenue will issue shares worth 19.99% of its outstanding stock to AnnJi. AJ201 has Orphan Drug Designation from the U.S. FDA and the European Medicines Agency, with safety demonstrated in Phase 1 trials. It is currently undergoing clinical evaluation for Kennedy's Disease.

Avenue Therapeutics (Nasdaq: ATXI) announced participation in a Type C meeting with the FDA on March 9, 2023, to discuss a study protocol assessing respiratory depression risks from IV Tramadol. The company aims to finalize this protocol based on feedback from a prior meeting on August 9, 2022, where the FDA approved the proposed study design. Additionally, on March 7, 2023, CEO Alexandra MacLean was appointed to the Board, and Dr. Jay Kranzler became Chairman. The company will hold its 2023 Annual Meeting on June 22, 2023, with stockholders needing to submit proposals by March 24, 2023.

Avenue Therapeutics, Inc. (Nasdaq: ATXI) has announced an exclusive license agreement with AnnJi Pharmaceutical Co., Ltd. for AJ201, a first-in-class therapy in clinical trials for spinal and bulbar muscular atrophy (SBMA), also known as Kennedy's Disease. This rare disease currently lacks FDA-approved treatments. The agreement involves an upfront payment of $3 million and equity issuance, with potential royalties on net sales. AJ201 has received Orphan Drug Designation and is part of a Phase 1b/2a trial in the U.S. aimed at assessing its safety and effectiveness. The company views this asset as pivotal for enhancing its therapeutic portfolio.

Aegis Capital Corp. has successfully facilitated a $3.25 million registered direct and private placement for Avenue Therapeutics, Inc. (NASDAQ:ATXI). Avenue Therapeutics focuses on developing therapies for central nervous system diseases and is headquartered in Miami, Florida. The company was founded by Fortress Biotech, Inc. (NASDAQ:FBIO). This funding aims to bolster Avenue Therapeutics’ pipeline and support its growth strategy. For more details, visit Avenue Therapeutics.

Avenue Therapeutics, Inc. (Nasdaq: ATXI) recently closed a registered direct offering and private placement with an institutional investor, raising approximately $3.25 million. The company issued 1,940,299 shares of common stock at a purchase price of $1.55 per share, alongside warrants with an exercise price also set at $1.55. The gross proceeds from this transaction will be directed towards general corporate purposes and working capital. Notably, these transactions comply with Nasdaq regulations, ensuring all offerings are priced appropriately.

Avenue Therapeutics (Nasdaq: ATXI) has entered into a definitive agreement with an institutional investor for a registered direct offering of 1,940,299 shares of common stock and pre-funded warrants. Concurrently, the company will issue the same investor 1,940,299 warrants, each with an exercise price of $1.55. The projected gross proceeds from these transactions amount to approximately $3.25 million, expected to close by January 31, 2023. The shares and warrants are priced at $1.55 and $0.125, respectively. Avenue plans to use the net proceeds for general corporate purposes and working capital.

Avenue Therapeutics, Inc. (Nasdaq: ATXI) reported Q3 2022 financial results, achieving key milestones in drug development for CNS diseases. The company had a fruitful FDA meeting regarding IV Tramadol, indicating a path for NDA resubmission, and it completed the acquisition of Baergic Bio, adding a novel therapy to its portfolio. Financially, Avenue's cash position decreased to $0.2 million as of September 30, 2022, but improved with $10.4 million from a public offering. The net loss was $0.7 million with a reduced loss per share of $0.45.