Astria Therapeutics, Inc. - ATXS STOCK NEWS

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.

Astria Therapeutics (Nasdaq:ATXS) announced two poster presentations at the American College of Allergy, Asthma, and Immunology (ACAAI) Annual Scientific Meeting in Boston on October 25, 2024. The presentations focus on Hereditary Angioedema (HAE) and quality of life data:

1. Dr. Aleena Banerji will present new quality of life data from the Phase 1b/2 trial of navenibart (STAR-0215) in a poster titled 'STAR-0215 Induces Rapid Improvements of Quality of Life in HAE Patients in the ALPHA-STAR Trial' at 3:30pm EST.

2. Dr. Donald Levy will present Astria-sponsored research on 'Quality of Life and Burden of Disease in Patients with Hereditary Angioedema and their Caregivers' at 3:45pm EST.

Both presentations will take place in Exhibit Hall A, highlighting Astria's commitment to developing therapies for allergic and immunologic diseases.

Astria Therapeutics (Nasdaq:ATXS) announced that the European Commission has granted Orphan Medicinal Product Designation (OMPD) to navenibart for the treatment of hereditary angioedema (HAE). Navenibart is a monoclonal antibody inhibitor of plasma kallikrein designed for long-acting HAE attack prevention. Initial results from the Phase 1b/2 ALPHA-STAR clinical trial showed a favorable safety profile and 90-96% reduction in monthly attack rates over six months.

The OMPD status, along with the FDA's orphan drug designation in the US, highlights the global unmet need for HAE treatment and navenibart's potential impact. Astria Therapeutics plans to progress navenibart into a Phase 3 trial in Q1 2025. OMPD in the EU provides incentives for drug development, including regulatory and financial benefits, for rare conditions affecting no more than five in 10,000 persons in the EU.

Astria Therapeutics (Nasdaq: ATXS), a biopharmaceutical company developing therapies for allergic and immunologic diseases, has granted stock options to three new employees under its 2022 Inducement Stock Incentive Plan. The grants, made on October 1, 2024, include options to purchase 52,000 shares of Astria's common stock at an exercise price of $11.43 per share, equal to the closing price on the grant date.

These options will vest over four years, with 25% vesting on the first anniversary of the employee's start date and the remaining shares vesting monthly over the following 36 months. The grants comply with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms of the 2022 Inducement Stock Incentive Plan and individual award agreements.