Avenue Therapeutics

Avenue Therapeutics, Inc. is a specialty pharmaceutical company, which engages in acquiring, licensing, and commercializing products for use in the intensive care hospital setting. It focuses on the development of intravenous tramadol, a potential alternative that could reduce the use of conventional opioids for patients suffering from acute pain. The company was founded on February 9, 2015 and is headquartered in New York, NY.

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Avenue Therapeutics, Inc. is a specialty pharmaceutical company, which engages in acquiring, licensing, and commercializing products for use in the intensive care hospital setting. It focuses on the development of intravenous tramadol, a potential alternative that could reduce the use of conventional opioids for patients suffering from acute pain. The company was founded on February 9, 2015 and is headquartered in Bay Harbor Islands, FL.

-A Phase 2a study of BAER-101 in epilepsy is planned to initiate in 2024 -A Phase 2a study of BAER-101 in epilepsy is planned to initiate in 2024

Avenue Therapeutics Announces High Potency and Full Efficacy in a Model of Generalized Seizures for its Novel GABA-A Receptor Potentiator, BAER-101, Supporting Phase 2 Clinical Study

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 Kennedy's Disease. A recent study used genetic analysis to estimate disease prevalence of 1:6,887 males.1 AJ201 is currently the lead drug candidate in the clinic for SBMA and enrollment in the trial is expected to be complete by the end of 2023 or early 2024 with potential topline data in 2024.

Avenue Therapeutics Announces First Patient Dosed in Phase 1b/2a Clinical Trial of AJ201 for the Treatment of Spinal and Bulbar Muscular Atrophy (Kennedy's Disease)

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 statistical analysis approach, for intravenous (IV) tramadol, which is in development for the treatment of acute post-operative pain in a medically supervised setting. The agreed upon non-inferiority study is designed to assess the theoretical risk of opioid-induced respiratory depression related to opioid stacking on IV tramadol compared to IV morphine.

Avenue Therapeutics Announces Agreement with the FDA on the Study Design and Analysis Approach of the Phase 3 Safety Study for IV Tramadol

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 Therapeutics Reports First Quarter 2023 Financial Results and Recent Corporate Highlights

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, 2023, at 4:00 p.m. EDT.

Avenue Therapeutics to Present at Aegis Capital Virtual Conference

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, regarding the development of intravenous (“IV”) Tramadol for the treatment of post-operative pain. The purpose of this meeting was to discuss and reach agreement with the FDA on the proposed study protocol that would assess the risk of opioid-induced respiratory depression related to opioid stacking on IV Tramadol compared to IV morphine.

Avenue Therapeutics Announces Regulatory Update Based on Type C Meeting with FDA and Next Steps in the Development of IV Tramadol

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 Therapeutics Reports Full Year 2022 Financial Results and Recent Corporate Highlights

Company to participate in Type C meeting for IV Tramadol with FDA on March 9, 2023 Company to participate in Type C meeting for IV Tramadol with FDA on March 9, 2023

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

AJ201 is being evaluated in a Phase 1b/2a clinical trial in the U.S. for the rare X-linked genetic neurodegenerative disease also known as Kennedy's Disease which currently has no FDA approved therapy AJ201 is being evaluated in a Phase 1b/2a clinical trial in the U.S. for the rare X-linked genetic neurodegenerative disease also known as Kennedy's Disease which currently has no FDA approved therapy

Avenue Therapeutics Enters into a Transformational License Agreement with AnnJi Pharmaceutical to Develop and Commercialize AJ201, a First-in-Class Clinical Asset for the Treatment of Spinal and Bulbar Muscular Atrophy

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NEW YORK, NY / ACCESSWIRE / January 31, 2023 / Aegis Capital Corp. acted as Exclusive Placement Agent on a $3.25 Million Registered Direct & Private Placement for Avenue Therapeutics, Inc. (NASDAQ:ATXI). About Avenue Therapeutics, Inc. Avenue Therapeutics, Inc. (Nasdaq:ATXI) is a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of central nervous system diseases.

Aegis Capital Corp. Acted as Exclusive Placement Agent on a $3.25 Million Registered Direct & Private Placement for Avenue Therapeutics, Inc. (NASDAQ:ATXI)

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. The Company issued 1,940,299 shares of common stock and pre-funded warrants to acquire common stock in a registered direct offering. In a concurrent private placement, the company also issued to the same investor a total of 1,940,299 warrants to purchase up to one share of common stock each at an exercise price of $1.55 per share. The private placement warrants will be exercisable immediately subject to registration and will have a 3-year term from the initial exercise date. Aggregate gross proceeds to the Company of both transactions were approximately $3.25 million. The transactions closed on January 31, 2023.

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

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 pre-funded warrants to acquire common stock in a registered direct offering. In a concurrent private placement, the company also agreed to issue to the same investor a total of 1,940,299 warrants to purchase up to one share of common stock each at an exercise price of $1.55 per share. The private placement warrants will be exercisable immediately subject to registration and will have a 3-year term from the initial exercise date. Aggregate gross proceeds to the Company of both transactions are expected to be approximately $3.25 million. The transactions are expected to close on or about January 31, 2023, subject to the satisfaction of customary closing conditions.

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

NEW YORK, Nov. 10, 2022 (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 (“CNS”), today reported financial results and recent corporate highlights for the third quarter ended September 30, 2022.

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

NEW YORK, Nov. 08, 2022 (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 (“CNS”) diseases, 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 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

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NEW YORK, NY / ACCESSWIRE / October 12, 2022 / Aegis Capital Corp. acted as Sole Bookrunner on a $12 Million Underwritten Public Offering for Avenue Therapeutics, Inc. (NASDAQ:ATXI). About Avenue Therapeutics, Inc. Avenue Therapeutics, Inc., a specialty pharmaceutical company, develops and commercializes products primarily for use in the acute/intensive care hospital setting.

Aegis Capital Corp. Acted as Sole Bookrunner on a $12 Million Underwritten Public Offering for Avenue Therapeutics, Inc. (NASDAQ:ATXI)

NEW YORK, Oct. 11, 2022 (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 underwritten public offering of 3,636,365 common and pre-funded units. Each common unit consists of one share of common stock and one warrant to purchase one share of common stock, and each pre-funded unit consists of one pre-funded warrant to purchase one share of common stock and one warrant to purchase one share of common stock. Each share of common stock (or pre-funded warrant) was sold together with one warrant at a combined purchase price of $3.30 per common unit (or $3.2999 per pre-funded unit after reducing $0.0001 attributable to the exercise price of the pre-funded warrants).  The Company also simultaneously closed on the sale of an additional 545,454 warrants to purchase common stock, which were sold pursuant to a partial exercise of the underwriter's over-allotment option. Avenue received net proceeds of approximately $10.4 million at closing after deducting underwriting discounts and commissions and other expenses of the offering.

Avenue Therapeutics Announces Closing of $12 Million Underwritten Public Offering

Avenue Therapeutics Inc (NASDAQ: ATXI) shares are trading lower by 62.64% to $2.35 Friday morning after the company priced a roughly 3.6 million unit offering at $3.30 per unit.

What In The World Is Going On With Avenue Therapeutics Stock?

NEW YORK, Oct. 06, 2022 (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 pricing of its underwritten public offering of 3,636,365 common and pre-funded units. Each common unit consists of one share of common stock and one warrant to purchase one share of common stock, and each pre-funded unit consists of one pre-funded warrant to purchase one share of common stock and one warrant to purchase one share of common stock. Each share of common stock (or pre-funded warrant) is being sold together with one warrant at a combined purchase price of $3.30 per common unit (or $3.2999 per pre-funded unit after reducing $0.0001 attributable to the exercise price of the pre-funded warrants).

Avenue Therapeutics Announces Pricing of $12 Million Underwritten Public Offering

It's been another bumpy day in the stock market, with many stocks opening higher only to lose momentum this afternoon. That said, some companies are outperforming meaningfully today.

ATXI Stock Alert: What to Know as Avenue Therapeutics Soars 150%

Source: Numstocker/Shutterstock.com Avenue Therapeutics (NASDAQ: ATXI ) stock is seeing wild movement on Friday following a reverse stock split and regulatory update. Starting with that reverse stock split, the company consolidated 15 shares of ATXI stock into a single share.

What Is Going on With Avenue Therapeutics (ATXI) Stock Today?

A 1-for-15 reverse split of Avenue Therapeutics (ATXI) has gone into effect. These are the details.

Avenue Therapeutics (ATXI) Stock: 1-For-15 Reverse Split Goes Into Effect

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NEW YORK, Sept. 22, 2022 (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 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.

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

News for Avenue Therapeutics Stock (ATXI)