Astria Therapeutics Stock Price, News & Analysis

Astria Therapeutics, Inc. (NASDAQ: ATXS) is a biopharmaceutical company focused on developing life‑changing therapies for patients and families affected by allergic and immunologic diseases. According to the company’s public statements, its mission centers on addressing serious immune‑mediated conditions with investigational monoclonal antibody therapies. Astria’s work is situated within pharmaceutical preparation manufacturing, with an emphasis on clinical‑stage drug development rather than commercialized products.

The company’s lead program is navenibart (STAR‑0215), described by Astria as an investigational monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema (HAE). Navenibart is being studied as a long‑acting, injectable prophylactic therapy intended to prevent HAE attacks. Astria reports that navenibart is administered subcutaneously in clinical trials and is being evaluated for dosing every three months (Q3M) and every six months (Q6M). The Phase 3 program includes the pivotal ALPHA‑ORBIT trial, a randomized, double‑blind, placebo‑controlled study assessing efficacy and safety over a six‑month treatment period, and the ORBIT‑EXPANSE long‑term trial, in which all participants receive navenibart on Q3M or Q6M regimens.

Earlier‑stage data for navenibart come from the ALPHA‑STAR Phase 1b/2 trial in adults with HAE Type 1 or 2. Astria has reported that this proof‑of‑concept trial, conducted across multiple international sites, evaluated safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and quality of life with single and multiple subcutaneous doses. In the full enrollment group of 29 patients, the company states that navenibart demonstrated rapid onset, robust and durable reductions in attack rates over six months of treatment, along with favorable safety and tolerability. All enrolled patients elected to continue treatment in the ALPHA‑SOLAR long‑term open‑label trial, which contributes to the safety database for future regulatory filings.

Astria has also entered into regional collaboration arrangements for navenibart. Under a license agreement with Kaken Pharmaceutical Co., Ltd., disclosed in an 8‑K filing, Astria granted Kaken exclusive rights to develop, package, and commercialize navenibart for the prevention of HAE attacks in Japan. The agreement includes an upfront payment, potential commercialization and sales milestones, and tiered royalties on net sales, as well as partial reimbursement of Phase 3 program costs. Kaken is responsible for regulatory submissions and commercialization in Japan, while supporting the ALPHA‑ORBIT Phase 3 trial in that country.

Astria’s second program, STAR‑0310, is an investigational monoclonal antibody OX40 antagonist in clinical development for the treatment of atopic dermatitis (AD). The company describes STAR‑0310 as a high‑potency, long‑acting antibody that incorporates YTE technology and is being evaluated in a Phase 1a randomized, double‑blind, placebo‑controlled, single ascending dose trial in healthy adults. Initial Phase 1a results reported by Astria indicate that STAR‑0310 demonstrated an extended half‑life of up to 68 days, pharmacodynamic evidence of durable cytokine inhibition over 16 to 20 weeks, and a tolerability profile without antibody‑dependent cellular cytotoxicity (ADCC)‑related side effects in the data presented. Astria has stated that these findings support the potential for infrequent administration and a wider therapeutic window compared with earlier OX40‑targeting antibodies, and that strategic opportunities for STAR‑0310 are being explored.

Within hereditary angioedema, Astria positions navenibart as a long‑acting plasma kallikrein inhibitor intended for prophylaxis. Public communications from the company emphasize goals of rapid and sustained attack prevention using a validated mechanism and a modality familiar to HAE patients and clinicians. The ALPHA‑ORBIT Phase 3 trial is designed to measure time‑normalized monthly HAE attacks at six months as the primary endpoint, with attack‑free rates as a key secondary endpoint. Trial sites are open across multiple regions, including North America, Europe, Asia, the Middle East, and Africa, with European Medicines Agency approval enabling activation of numerous sites in EU member states.

In the atopic dermatitis program, Astria describes STAR‑0310 as targeting OX40, a receptor involved in immune pathway modulation. The Phase 1a trial in healthy subjects assesses safety, tolerability, pharmacokinetics, and immunogenicity across several subcutaneous dose levels. Biomarker analyses reported by the company show ex vivo inhibition of multiple cytokines over the observation period, which Astria interprets as evidence of broad and durable immune modulation relevant to AD. The company has presented STAR‑0310 data at international dermatology and allergy meetings, reflecting its focus on academic and clinical engagement in the allergy and immunology community.

Astria’s corporate strategy, as described in its press releases and SEC filings, is concentrated on advancing these investigational programs through clinical development and regulatory pathways, supported by collaborations and licensing where appropriate. The company highlights its mission to bring life‑changing therapies to people with allergic and immunologic diseases and has communicated that its operating plans and collaborations, such as the Kaken license, are structured to support ongoing Phase 3 development of navenibart and early‑stage development of STAR‑0310.

In October 2025, Astria and BioCryst Pharmaceuticals, Inc. announced a definitive agreement under which BioCryst agreed to acquire all outstanding shares of Astria for a mix of cash and BioCryst common stock. An 8‑K filed by Astria describes the Agreement and Plan of Merger, under which a BioCryst subsidiary will merge with and into Astria, with Astria surviving as a wholly owned subsidiary of BioCryst at the effective time of the merger, subject to customary closing conditions and stockholder and regulatory approvals. The filing notes that, if the merger is consummated, Astria’s common stock is expected to be delisted from the Nasdaq Global Market and deregistered under the Securities Exchange Act of 1934. Until completion of the transaction, Astria continues to report as an independent public company.

For investors and observers, Astria Therapeutics represents a clinical‑stage biopharmaceutical issuer focused on rare disease and immunology indications, with its value proposition tied to the progress, safety, and efficacy outcomes of navenibart in hereditary angioedema and STAR‑0310 in atopic dermatitis, as well as to the terms and completion of its announced acquisition by BioCryst.