Avenue Therapeutics

56 articles with Avenue Therapeutics

• Avenue Therapeutics Reports Full Year 2022 Financial Results and Recent Corporate Highlights

  3/30/2023

  Avenue Therapeutics, Inc. reported financial results and recent corporate highlights for the year ended December 31, 2022.

• AnnJi Pharmaceutical Announced A Licensing Agreement With Avenue Therapeutics To Develop And Commercialize AJ201, A First-In-Class Clinical Asset For The Treatment Of Kennedy's Disease

  3/10/2023

  AnnJi Pharmaceutical Co. (AnnJi) has entered into an exclusive license agreement with Avenue Therapeutics Inc. (Avenue, NASDAQ: ATXI) for the development and commercialization of AJ201 in the U.S., Canada , European Union, Great Britain , and Israel for spinal and bulbar muscular atrophy (SBMA), also known as Kennedy's Disease.

• Avenue Therapeutics Provides Regulatory Update on IV Tramadol and Other Corporate Updates

  3/8/2023

  Avenue Therapeutics, Inc. 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 depression related to opioid stacking on intravenous tramadol relative to an approved opioid analgesic.

• Avenue Therapeutics Enters into a Transformational License Agreement with AnnJi Pharmaceutical to Develop and Commercialize AJ201

  3/2/2023

  Avenue Therapeutics, Inc. today announced that it has entered into an exclusive license agreement with AnnJi Pharmaceutical Co., Ltd. (“AnnJi”), a Taiwanese clinical-stage drug company, for AJ201, a first-in-class clinical asset currently in a Phase 1b/2a study in the U.S. for the treatment of spinal and bulbar muscular atrophy (“SBMA”), also known as Kennedy's Disease.

• Avenue Therapeutics Announces Closing of $3.25 Million Registered Direct and Private Placement

  1/31/2023

  Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”) today announced the closing of its previously announced registered direct offering and concurrent private placement with a single institutional accredited investor.

• Avenue Therapeutics Announces $3.25 Million Registered Direct and Private Placement Priced at the Market Under Nasdaq Rules

  1/27/2023

  Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”) 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 pre-funded warrants to acquire common stock in a registered direct offering.

• Avenue Therapeutics Reports Third Quarter 2022 Financial Results and Recent Corporate Highlights

  11/10/2022

  Avenue Therapeutics, Inc. today reported financial results and recent corporate highlights for the third quarter ended September 30, 2022.

• Avenue Therapeutics Completes the Acquisition of Baergic Bio and its Selective GABA-A α2/3 Receptor Positive Allosteric Modulator for the Treatment of Central Nervous System Disorders

  11/8/2022

  Avenue Therapeutics, Inc. today announced the closing of the acquisition of Baergic Bio, Inc. (“Baergic Bio”) pursuant to the previously disclosed Share Contribution Agreement with its parent company, Fortress Biotech, Inc.

• Avenue Therapeutics Announces Closing of $12 Million Underwritten Public Offering

  10/11/2022

  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 underwritten public offering of 3,636,365 common and pre-funded units.

• Avenue Therapeutics Announces Pricing of $12 Million Underwritten Public Offering

  10/7/2022

  Avenue Therapeutics, Inc., a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of central nervous system diseases, announced the pricing of its underwritten public offering of 3,636,365 common and pre-funded units.

• Avenue Therapeutics Announces Reverse Stock Split and Provides Regulatory Update for IV Tramadol Including Receipt of Type A Meeting Minutes from the FDA

  9/22/2022

  Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”) today announced that it will effect a 1-for-15 reverse split of its common stock, which will be effective for trading purposes on the Nasdaq Capital Market as of the commencement of trading on September 23, 2022, and also provided a regulatory update related to its intravenous (“IV”) Tramadol product candidate.

• 

  FDA Ad Com Comes Down Hard on Avenue's IV Tramadol

  2/16/2022

  The FDA committee voted 8 yes and 14 no. The decision now goes back to the OND to decide the FDDR on Avenue Therapeutics' IV Tramadol.

• Avenue Therapeutics Stock Trading Halted TodayFDA Advisory Committee to review IV tramadol New Drug Application

  2/15/2022

  Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, today announced that NASDAQ has halted trading of the Company’s common stock.

• Avenue Therapeutics Announces Outcome of FDA Advisory Committee Meeting on IV Tramadol

  2/15/2022

  Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), today announced the outcome of the U.S. Food and Drug Administration (“FDA”) joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee on IV tramadol.

• Avenue Therapeutics Prices $2.0 Million Underwritten Public Offering of Common Stock

  12/13/2021

  Avenue Therapeutics, Inc., a company focused on the development of intravenous tramadol for the U.S. market, announced the pricing of an underwritten public offering with gross proceeds to the Company expected to be approximately $2.0 million, before deducting underwriting discounts and commissions and other estimated expenses payable by the Company.

• Avenue Therapeutics Announces FDA Advisory Committee Meeting to Review IV Tramadol NDA Tentatively Scheduled for February 15, 2022

  11/29/2021

  Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue” or the “Company”), a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, today announced that the FDA has informed the Company that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee is tentatively scheduled for February 15, 2022.

• Avenue Therapeutics Announces Exercise and Closing of Underwriter’s Over-Allotment Option

  11/17/2021

  Avenue Therapeutics, Inc. today announced that the underwriter of its previously announced underwritten public offering has exercised, in full, its option to purchase an additional 292,018 shares of common stock at a price of $1.34 per share.

• Avenue Therapeutics Announces Closing of Public Offering of Common Stock - Nov 12, 2021

  11/12/2021

  Avenue Therapeutics, Inc., a company focused on the development of intravenous tramadol for the U.S. market, announced the closing of its public offering of 1,946,787 shares of common stock at a public offering price of $1.34.

• Avenue Therapeutics Prices $2.6 Million Underwritten Public Offering of Common Stock

  11/10/2021

  Avenue Therapeutics, Inc., a company focused on the development of intravenous tramadol for the U.S. market, announced the pricing of an underwritten public offering with gross proceeds to the Company expected to be approximately $2.6 million, before deducting underwriting discounts and commissions and other estimated expenses payable by the Company.

• Avenue Therapeutics Receives Interim Response to its Formal Dispute Resolution Request from U.S. Food and Drug Administration Office of New Drugs

  10/25/2021

  Avenue Therapeutics, Inc. today announced that it has received a written interim response from the Office of New Drugs (“OND”) of the U.S. Food and Drug Administration (“FDA”).