Baergic shareholders eligible to receive up to approximately $82 million in potential development, regulatory, and sales milestones plus a tiered mid-to-high single digit royalty on global net sales from Axsome MIAMI, Nov. 06, 2025 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc . (OTC: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the... Read More

MIAMI, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results and recent corporate highlights for the third quarter ended September 30, 2024. “We have generated considerable momentum this past quarter in... Read More

MIAMI, Oct. 09, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Alexandra MacLean, M.D., Chief Executive Officer of Avenue Therapeutics, will participate in a fireside chat at Maxim Group’s 2024 Healthcare Virtual Summit... Read More

MIAMI, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Alexandra MacLean, M.D., Chief Executive Officer of Avenue Therapeutics, will participate in the following upcoming investor conferences: H.C. Wainwright... Read More

Last patient visit complete in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy; topline data anticipated in second half of 2024 Raised $4.4 million in gross proceeds from a May 2024 warrant exercise transaction MIAMI, Aug. 09, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and... Read More

MIAMI, June 20, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Alexandra MacLean, M.D., Chief Executive Officer of Avenue Therapeutics, will present at the H.C. Wainwright 5th Annual Neuro Perspectives Virtual... Read More

MIAMI, May 16, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the completion of the last patient’s final visit in the Company’s Phase 1b/2a clinical trial of AJ201 for the treatment of spinal and bulbar muscular atrophy... Read More

Raised a total of $9.4 million in gross proceeds from warrant exercise transactions since January 2024 MIAMI, May 15, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results and recent corporate highlights for the... Read More

MIAMI, April 29, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the entry into definitive agreements for the immediate exercise of certain outstanding warrants to purchase an aggregate of 689,680 shares of the Company’s... Read More

MIAMI, April 24, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that it will effect a 1-for-75 reverse split of its issued and outstanding common stock. Avenue expects its common stock to begin trading on a split-adjusted... Read More

MIAMI, March 25, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that it will host a virtual key opinion leader (“KOL”) event highlighting expert perspectives on spinal bulbar muscular atrophy (“SBMA”), also known as Kennedy's... Read More

Enrollment completed in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy; topline data expected in second quarter of 2024 Presented positive BAER-101 preclinical data at American Epilepsy Society (AES) and American Society for Experimental Neurotherapeutics (ASENT) Annual Meetings and in publication Drug Development Research Final agreement reached with FDA on study design and analysis approach for... Read More

MIAMI, March 15, 2024 (GLOBE NEWSWIRE) - - Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that by decision dated March 11, 2024, the Nasdaq Hearings Panel granted the Company’s request for an extension to evidence compliance with all applicable... Read More

BAER-101 demonstrated full suppression of seizure activity in SynapCell's GAERS model of absence epilepsy, a proven indicator of efficacy in anti-seizure drug development with high predictability of response in humans MIAMI, March 11, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies... Read More

MIAMI, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the publication of preclinical in vivo data in Drug Development Research highlighting BAER-101’s full suppression of seizure activity using the Genetic Absence... Read More

MIAMI, Jan. 11, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Alexandra MacLean, M.D., Chief Executive Officer, will present a corporate update at the Sidoti January Micro-Cap Investor Conference on Thursday, January... Read More

MIAMI, Jan. 05, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the entry into warrant exercise agreements with existing accredited investors for the immediate exercise of certain outstanding warrants to purchase an aggregate... Read More

MIAMI, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that it has reached final agreement with the U.S. Food and Drug Administration (“FDA”) on the Phase 3 safety study protocol and statistical analysis approach,... Read More

Topline data remains on track for second quarter of 2024 MIAMI, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that all patients have been enrolled in the Phase 1b/2a clinical trial of AJ201 for the treatment of... Read More

MIAMI, Dec. 01, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Amy Chappell, M.D., FAAN, will be presenting preclinical in vivo data evaluating BAER-101 using the SynapCell's Genetic Absence Epilepsy Rat from Strasbourg... Read More

Phase 1b/2a clinical trial of AJ201 remains on track to report topline data in second quarter of 2024 Positive BAER-101 preclinical data accepted for presentation at American Epilepsy Society (AES) Annual Meeting Agreement reached with U.S. FDA on study design and analysis approach for Phase 3 safety study of IV tramadol Raised $5 million in gross proceeds from public equity offering MIAMI, Nov. 13, 2023 (GLOBE NEWSWIRE) --... Read More

MIAMI, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the closing of its previously announced public offering of an aggregate of 16,633,400 units (or pre-funded units in lieu thereof) at a public offering price of... Read More

MIAMI, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the pricing of its public offering of an aggregate of 16,633,400 units at a public offering price of $0.3006 per unit. Each unit consists of (i) one share of... Read More

MIAMI, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Alexandra MacLean, M.D., Chief Executive Officer, will present a corporate update at the H.C. Wainwright 25th Annual Global Investment Conference scheduled... Read More

First patient dosed in Phase 1b/2a clinical trial of AJ201; topline data anticipated in first half of 2024 Positive BAER-101 preclinical data demonstrate excellent anti-seizure activity in translational animal model; Phase 2a trial in epilepsy planned to initiate in 2024 Agreement reached with U.S. FDA on study design and analysis approach for Phase 3 safety study of IV tramadol MIAMI, Aug. 10, 2023 (GLOBE NEWSWIRE) --... Read More

MIAMI, Aug. 01, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, announced today that BAER-101, the Company’s potentially best-in-class selective GABA-A α2,3 positive allosteric modulator (“PAM”), significantly suppressed seizures in a... Read More

MIAMI, July 27, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that the first patient has been dosed in the Phase 1b/2a clinical trial of AJ201 for the treatment of spinal and bulbar muscular atrophy (“SBMA”), also known as... Read More

MIAMI, July 25, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that it has reached agreement with the U.S. Food and Drug Administration (“FDA”) on key elements of the Phase 3 safety study, including the primary endpoint and... Read More

MIAMI, May 12, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results and recent corporate highlights for the first quarter ended March 31, 2023. “Avenue is progressing its neuro-focused clinical stage pipeline and... Read More

MIAMI, April 27, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Alexandra MacLean, M.D., Chief Executive Officer, will present a corporate update at the Aegis Capital Virtual Conference taking place on Thursday, May 4,... Read More

MIAMI, April 17, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of rare and neurologic diseases, today announced that it has received official meeting minutes from the Type C meeting with the U.S. Food and Drug Administration (“FDA”) conducted on March 9, 2023,... Read More

MIAMI, March 30, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of rare and neurologic diseases, today reported financial results and recent corporate highlights for the year ended December 31, 2022. “Avenue has transformed into a neuro-focused specialty... Read More

MIAMI, March 08, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of rare and neurologic diseases, today announced that it will participate in a Type C meeting with the FDA on March 9, 2023 to discuss a proposed study protocol to assess the risk of respiratory... Read More

MIAMI, March 02, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of rare and neurologic diseases, today announced that it has entered into an exclusive license agreement with AnnJi Pharmaceutical Co., Ltd. (“AnnJi”), a Taiwanese clinical-stage drug company, for... Read More

MIAMI, Jan. 31, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of central nervous system diseases, today announced the closing of its previously announced registered direct offering and concurrent private placement with a single institutional accredited investor.... Read More

MIAMI, Jan. 27, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of central nervous system diseases, today announced that it has entered into a definitive agreement with a single institutional investor for the purchase and sale of 1,940,299 shares of common stock and... Read More