Astria Therapeutics, Inc. - ATXS STOCK NEWS

Astria Therapeutics (NASDAQ:ATXS) has announced the design of ALPHA-ORBIT, a pivotal Phase 3 trial for navenibart in hereditary angioedema (HAE). The trial will evaluate both 3-month (Q3M) and 6-month (Q6M) dosing schedules over a 6-month treatment period.

The global, randomized, double-blind, placebo-controlled study will enroll up to 145 patients with Type 1 or 2 HAE. Patients will be randomized into three navenibart dose arms: 600mg initial dose followed by 300mg Q3M, 600mg Q6M, and 600mg Q3M, or placebo. The primary endpoint is time-normalized monthly HAE attacks at 6 months.

The Phase 3 trial initiation is expected in Q1 2025, with top-line results anticipated in early 2027. The program design incorporates feedback from regulators and is intended to support global registration. Previous Phase 1b/2 ALPHA-STAR trial results showed 90-95% reduction in mean monthly attack rate and up to 67% attack-free rate over 6 months.

Astria Therapeutics (ATXS), a biopharmaceutical company developing therapies for allergic and immunologic diseases, has granted 58,650 stock options to two new employees under its 2022 Inducement Stock Incentive Plan. The options were granted on January 2, 2025, with an exercise price of $8.97, matching the closing price of Astria's common stock on the grant date.

The options will vest over a four-year period, with 25% vesting after the first year of employment and the remaining shares vesting monthly over the following 36 months. The grants were made in accordance with Nasdaq Listing Rule 5635(c)(4), which allows for inducement grants to new employees.

Astria Therapeutics (NASDAQ:ATXS) announced positive final results from the ALPHA-STAR Phase 1b/2 trial of navenibart for hereditary angioedema (HAE). The trial, involving 16 patients, demonstrated significant efficacy with 90-95% mean monthly attack rate reduction over 6 months. Key highlights include:

- 67% attack-free rate in Cohorts 2 and 3
- Favorable safety profile with no serious adverse events
- Support for both quarterly and semi-annual dosing regimens
- Phase 3 initiation planned for Q1 2025

The trial evaluated three cohorts with different dosing regimens, all showing over 90% reduction in monthly attack rates and substantial decreases in moderate/severe attacks. The company expects to present detailed data at an upcoming scientific conference and anticipates topline Phase 3 results by year-end 2026.

Astria Therapeutics has announced FDA clearance of its IND application for STAR-0310, a monoclonal antibody OX40 antagonist aimed at treating atopic dermatitis (AD) and potentially other conditions. The Phase 1a trial is set to begin in Q1 2025 with initial proof-of-concept results expected by Q3 2025. Proof-of-concept results in AD patients are anticipated by Q2 2026. According to Chris Morabito, Chief Medical Officer, STAR-0310 is designed to leverage existing knowledge on OX40 receptor and ligand programs. The drug's high affinity and potency, coupled with low ADCC, could offer a wider therapeutic window and potentially allow dosing as infrequently as every six months due to its long half-life and disease-modifying potential.

Astria Therapeutics (Nasdaq:ATXS) has granted stock options to two new employees under its 2022 Inducement Stock Incentive Plan. The options allow purchase of 32,500 shares at an exercise price of $10.37, matching the closing price on December 2, 2024. 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. This grant complies with Nasdaq Listing Rule 5635(c)(4) for inducement awards to new employees.

Astria Therapeutics (NASDAQ:ATXS) reported Q3 2024 financial results and provided updates on its key programs. The company's lead drug candidate navenibart is on track for Phase 3 initiation in Q1 2025, with final ALPHA-STAR trial results expected in Q4 2024. Initial results showed 90-96% reduction in HAE attack rates. The company reported cash position of $344.3 million, Q3 net loss of $24.5 million ($0.42 per share), and increased R&D expenses to $20.5 million. Their second program, STAR-0310 for atopic dermatitis, is progressing toward IND submission by year-end 2024.

Astria Therapeutics (Nasdaq: ATXS), a biopharmaceutical company developing therapies for allergic and immunologic diseases, announced that CEO Jill C. Milne will participate in a fireside chat at the Jefferies London Healthcare Conference. The presentation is scheduled for November 20th at 12:00pm GMT in London. A webcast will be available live and archived for 30 days on the company's investor website.

Astria Therapeutics (Nasdaq:ATXS) has granted stock options for 210,000 shares to two new employees under its 2022 Inducement Stock Incentive Plan. The options, priced at $11.32 per share (matching the closing price on November 1, 2024), will vest over four years, with 25% vesting after one year and the remainder vesting monthly over the following 36 months. This grant complies with Nasdaq Listing Rule 5635(c)(4) for inducement awards to new employees.

Astria Therapeutics (Nasdaq: ATXS) has announced its upcoming presentation of interim quality of life results from the ALPHA-STAR trial of navenibart (STAR-0215) at the Canadian Society of Allergy and Clinical Immunology Annual Scientific Meeting in Banff, Alberta. The presentation will take place on November 7, 2024.

Dr. Adil Adatia from the University of Alberta will present a poster focusing on quality of life improvements in hereditary angioedema (HAE) patients treated with STAR-0215. The poster will be displayed in the Van Horne Foyer from 10:00am MDT on November 7 until November 9.