Welcome to our dedicated page for Astria Therapeutics news (Ticker: ATXS), a resource for investors and traders seeking the latest updates and insights on Astria Therapeutics stock.
Astria Therapeutics, Inc. (NASDAQ: ATXS) generates news primarily as a clinical‑stage biopharmaceutical company focused on allergic and immunologic diseases. Company updates center on its lead investigational therapy navenibart (STAR‑0215), a monoclonal antibody inhibitor of plasma kallikrein in development for hereditary angioedema (HAE), and on STAR‑0310, an investigational OX40 antagonist in development for atopic dermatitis.
News items about Astria often highlight progress in its clinical programs. For navenibart, this includes announcements on the ALPHA‑STAR Phase 1b/2 trial results in HAE patients, the global ALPHA‑ORBIT Phase 3 randomized, double‑blind, placebo‑controlled trial, and the ORBIT‑EXPANSE long‑term extension trial where all participants receive navenibart on every‑three‑month or every‑six‑month dosing schedules. Press releases have described attack‑rate reductions, safety and tolerability findings, and patient‑reported quality‑of‑life measures, as well as enrollment milestones and trial site activations across multiple regions.
Coverage also includes early‑stage results for STAR‑0310, where Astria has reported Phase 1a data in healthy subjects, including extended half‑life, durable cytokine inhibition over 16 to 20 weeks, and the absence of antibody‑dependent cellular cytotoxicity‑related side effects in the data presented. These updates are frequently tied to scientific and medical conferences in allergy and dermatology.
In addition, Astria’s news flow features corporate and strategic developments such as the definitive merger agreement with BioCryst Pharmaceuticals, Inc., under which BioCryst has agreed to acquire Astria for a mix of cash and stock, and a license agreement with Kaken Pharmaceutical Co., Ltd. for navenibart rights in Japan. Investors following ATXS news can expect a mix of clinical trial readouts, regulatory and collaboration announcements, financial updates, and transaction‑related disclosures.
Astria Therapeutics (NASDAQ:ATXS) has expanded enrollment for its Phase 3 ALPHA-ORBIT trial of navenibart, a monoclonal antibody treatment for hereditary angioedema (HAE), to include clinical sites in the European Union. The trial, which received European Medicines Agency (EMA) approval, will activate 32 sites across 10 EU countries.
The global Phase 3 pivotal trial will evaluate navenibart's efficacy and safety in up to 145 participants with HAE Type 1 or Type 2, with dosing intervals of 3 or 6 months. The study's primary endpoint focuses on monthly HAE attacks at 6 months, while a key secondary endpoint measures the proportion of attack-free participants.
Following 6 months in ALPHA-ORBIT, eligible participants may enter the ORBIT-EXPANSE long-term trial, featuring patient-centered flexible dosing.
Astria Therapeutics (Nasdaq:ATXS), a biopharmaceutical company developing therapies for allergic and immunologic diseases, has granted inducement stock options to three new employees. The options allow purchase of 128,000 shares at an exercise price of $6.59 per share, matching the closing price on September 2, 2025.
The options, granted under Astria's 2022 Inducement Stock Incentive Plan, will vest over four years with 25% vesting after one year and the remainder vesting monthly over the following 36 months, contingent on continued employment.
Astria Therapeutics (NASDAQ:ATXS) has announced it will present initial Phase 1a trial data for STAR-0310, their long-acting OX40 receptor antagonist, at the upcoming EADV Congress 2025 in Paris. The presentation will be delivered by Dr. Stephan Weidinger, Director of Dermatology and Allergy at the University Medical Center Kiel, on September 17, 2025.
The late-breaking oral presentation will focus on early proof-of-concept data, including safety, pharmacokinetics (PK), and pharmacodynamics (PD) results from healthy participants in the Phase 1a trial.
Astria Therapeutics (NASDAQ:ATXS), a biopharmaceutical company specializing in allergic and immunologic disease therapies, has announced its participation in the upcoming Cantor Global Healthcare Conference. CEO Jill C. Milne, Ph.D. will engage in a fireside chat on September 4 at 3:20pm ET.
The presentation will be accessible via webcast, with a replay available on the company's investor relations website for 30 days after the event.
Astria Therapeutics (NASDAQ:ATXS) reported Q2 2025 financial results and announced a significant licensing deal with Kaken Pharmaceutical for Japanese rights to navenibart, worth up to $32 million plus royalties up to 30%. The company's cash position stands at $259.2 million, with an extended runway into 2028.
The Phase 3 ALPHA-ORBIT trial for navenibart in Hereditary Angioedema is progressing well across multiple countries, with topline data expected in early 2027. Initial results from the ALPHA-SOLAR trial showed promising outcomes with 92% mean and 97% median reduction in monthly attack rates.
Q2 2025 financial results showed a net loss of $33.1 million ($0.57 per share), compared to $24.2 million ($0.43 per share) in Q2 2024. The company's STAR-0310 program for atopic dermatitis is advancing with Phase 1a results expected in Q3 2025.
Astria Therapeutics (NASDAQ:ATXS) has entered into an exclusive licensing agreement with Kaken Pharmaceutical for the development and commercialization of navenibart in Japan. Navenibart, a long-acting monoclonal antibody inhibitor of plasma kallikrein, is in Phase 3 development for hereditary angioedema (HAE) prevention.
The deal includes an upfront payment of $16 million, potential additional $16 million in milestones, and tiered royalties up to 30% of net sales. Kaken will support the ALPHA-ORBIT Phase 3 trial in Japan and handle regulatory submissions. The agreement extends Astria's cash runway to support operations into 2028.
Astria Therapeutics (NASDAQ:ATXS), a biopharmaceutical company developing therapies for allergic and immunologic diseases, has granted inducement stock options to two new employees. The options allow for the purchase of 180,000 shares of common stock at an exercise price of $6.56 per share, matching the closing price on August 1, 2025.
The options were granted under Astria's 2022 Inducement Stock Incentive Plan and will vest over four years, with 25% vesting after one year and the remainder vesting monthly over the following 36 months, contingent on continued employment.
Astria Therapeutics (NASDAQ:ATXS) announced its participation in the 2025 US Hereditary Angioedema Association (HAEA) National Summit in Baltimore, Maryland from July 10-13, 2025. The company will present four posters focused on their drug candidate navenibart for Hereditary Angioedema (HAE) treatment.
The presentations include: a Phase 3 trial overview (ALPHA-ORBIT), combined safety and efficacy data from Phase 1b/2 and long-term trials, recruitment challenges in rare disease trials, and attack severity reduction data from the ALPHA-STAR Phase 1b/2 trial. The posters will be displayed on July 11 (8:30am-6:00pm ET) and July 12 (8:30am-1:30pm ET).
Astria Therapeutics (Nasdaq:ATXS), a biopharmaceutical company developing therapies for allergic and immunologic diseases, has granted stock options to six new employees under its 2022 Inducement Stock Incentive Plan. The options allow purchase of 119,860 shares at an exercise price of $5.43 per share, matching the closing price on July 1, 2025.
The options will vest over four years, with 25% vesting after one year and the remainder vesting monthly over the following 36 months, contingent on continued employment.