Astria Therapeutics Inc Stock Price, News & Analysis

Astria Therapeutics (NASDAQ:ALAB) reported positive Phase 1a results for STAR-0310, a YTE half-life extended OX40 antagonist in healthy volunteers on November 10, 2025.

Key findings: half-life up to 68 days, dose-proportional PK, sustained ex vivo cytokine inhibition (IL-2, IL-22, IL-31, IL-4) for 16–20 weeks after a single subcutaneous dose, no serious TEAEs or discontinuations, and no ADCC-related events. The single-ascending-dose trial enrolled 32 adults across 150–1,200 mg cohorts with follow-up windows up to Day 168 for the 150 mg cohort. Company plans a development update in coming months.

Astria Therapeutics (NASDAQ:ATXS) reported final results from the fully enrolled ALPHA-STAR Phase 1b/2 trial of navenibart in hereditary angioedema (HAE) patients (n=29), showing strong efficacy and a favorable safety profile through six months.

Key numeric results: mean/median attack-rate reductions were 84%/93% (Cohort 1, single 450 mg), 90%/100% (Cohort 2, 600 mg then 300 mg), and 92%/100% (Cohort 3, two 600 mg doses). Cohorts 2 and 3 had attack-free rates of 62% and 67%. No serious treatment-emergent adverse events or discontinuations were reported; all 29 patients enrolled in the long-term extension. The Phase 3 ALPHA-ORBIT program is enrolling with topline results expected in early 2027.

Astria Therapeutics (Nasdaq: ATXS) will present final results from the ALPHA-STAR Phase 1b/2 trial of navenibart in hereditary angioedema (HAE) at the American College of Allergy, Asthma, and Immunology Annual Scientific Meeting.

Presenter: Aleena Banerji, M.D., Professor of Medicine at Harvard Medical School and Clinical Director, Allergy and Clinical Immunology at Massachusetts General Hospital. Date & time: Saturday, November 8, 2025 at 12:15 PM EST. Location: e-poster area, West Exhibit Hall, Monitor 23, ACAAI Annual Meeting in Orlando, Florida.

BioCryst (Nasdaq: BCRX) agreed to acquire Astria Therapeutics (Nasdaq: ATXS) for an implied value of $13.00 per ATXS share and about $700 million enterprise value. The deal combines BioCryst’s oral HAE franchise with Astria’s injectable Phase 3 candidate navenibart, which has pivotal ALPHA-ORBIT topline data expected in early 2027. BioCryst expects to remain non-GAAP profitable and cash flow positive after closing and to be accretive to operating profit in the first full year after navenibart launch. Closing is expected in Q1 2026, subject to approvals; Astria stockholders would own ~15% of the combined company.

Astria Therapeutics (NASDAQ:ATXS) will present two posters at the Canadian Society of Allergy and Clinical Immunology (CSACI) 80th Anniversary Scientific Meeting in Vancouver, October 15–18, 2025.

Presenters include Dr. Adil Adatia, sharing initial ALPHA-SOLAR long‑term results on navenibart in hereditary angioedema (HAE), and Kusumam Joseph, Ph.D., presenting details on the global Phase 3 ALPHA-ORBIT trial of navenibart. Both posters will be displayed in the poster hall at Vancouver Convention Centre (East) from 9:00 AM PDT on Oct 16 to 2:45 PM PDT on Oct 18, 2025. The presentations cover long‑term safety, efficacy, quality of life, and Phase 3 trial design for navenibart in HAE.

Astria Therapeutics (NASDAQ:ATXS) announced on October 8, 2025 the initiation of the Phase 3 ORBIT-EXPANSE long-term trial of navenibart for people with hereditary angioedema (HAE).

ORBIT-EXPANSE follows the pivotal ALPHA-ORBIT Phase 3 trial and is designed to support global registration. Eligible participants who complete ALPHA-ORBIT may continue into ORBIT-EXPANSE, where all participants will receive navenibart on Q3M or Q6M regimens. The trial has two parts: Part 1 involves a fixed dosing period of at least 6 months; Part 2 offers a patient-centered flexible dosing period allowing regimen switches. ClinicalTrials.gov identifier: NCT07204938.

Astria Therapeutics (Nasdaq: ATXS) announced presentations at the 2025 HAEi Regional Conference EMEA in Rome, Italy, October 10-12, 2025. The company will present one poster and one oral session on navenibart.

Dr. William Lumry will present a poster on ALPHA-ORBIT (a global Phase 3, randomized, double-blind, placebo-controlled trial) on Oct 10, 2025 at 6:30pm CEST, and an oral presentation sharing initial safety and efficacy data from ALPHA-STAR (Phase 1b/2) on Oct 11, 2025 at 9:45am CEST.

Astria Therapeutics (Nasdaq: ATXS) granted inducement stock options to purchase 173,000 shares on October 1, 2025 under its 2022 Inducement Stock Incentive Plan.

The grants were made as inducement awards to three employees in accordance with Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $7.54, equal to the closing common stock price on the grant date, and vest over four years: 25% at the first anniversary of employment (which preceded the grant date) and the remainder monthly over 36 months, subject to continued employment and the plan/award agreement terms.

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.