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. (symbol: ATXS) is a pioneering biopharmaceutical company dedicated to developing transformative treatments for rare and niche allergic and immunological diseases. With a mission to improve the lives of patients and families impacted by these conditions, Astria Therapeutics is at the forefront of innovative medical research and development.
The company’s lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein. This promising therapy is currently in preclinical development, targeting the treatment of hereditary angioedema (HAE), a rare genetic disorder characterized by recurrent and severe swelling. By inhibiting plasma kallikrein, STAR-0215 aims to prevent the debilitating effects of HAE, offering hope to patients worldwide.
Astria Therapeutics is also advancing another significant product candidate, STAR-0310. This monoclonal antibody OX40 antagonist is being developed to treat atopic dermatitis (AD), an immune disorder that causes chronic skin inflammation and intense itching. Currently in preclinical development, STAR-0310 targets the immune pathways involved in AD, potentially providing relief and improved quality of life for sufferers.
Recently, Astria Therapeutics has made significant strides in its research and development efforts. The company remains committed to advancing its pipeline and exploring strategic partnerships to bring these innovative therapies to market. Financially, Astria Therapeutics continues to focus on maintaining a strong balance sheet to support its ambitious research programs and clinical trials.
In addition to its core projects, Astria Therapeutics actively engages with the medical community, patient advocacy groups, and regulatory bodies to ensure its treatments meet the highest standards of efficacy and safety. By fostering these collaborations, the company aims to accelerate the delivery of breakthrough therapies to those in need.
For the latest updates on Astria Therapeutics, including news on their clinical trials, partnerships, and corporate developments, stay tuned to StockTitan.
Astria Therapeutics (NASDAQ: ATXS) has initiated the ALPHA-ORBIT Phase 3 pivotal trial of navenibart for hereditary angioedema (HAE). The global, randomized, double-blind, placebo-controlled study will evaluate the drug's efficacy and safety over 6 months in up to 135 adults and 10 adolescents with HAE Type 1 or 2.
The trial features three dosing arms for adults: 600mg followed by 300mg every 3 months (Q3M), 600mg every 6 months (Q6M), and 600mg Q3M, plus placebo. Adolescents will receive 600mg followed by 300mg Q3M. The primary endpoint is time-normalized monthly HAE attacks at 6 months.
The Phase 3 program design was based on positive Phase 1b/2 ALPHA-STAR trial results, which demonstrated 90-95% reduction in mean monthly attack rate and up to 67% attack-free rate over 6 months. Top-line results are expected in early 2027.
Astria Therapeutics (Nasdaq: ATXS), a biopharmaceutical company developing therapies for allergic and immunologic diseases, announced that CEO Jill C. Milne, Ph.D. will participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference.
The presentation is scheduled for Tuesday, March 4th at 9:50am ET in Boston, MA. Interested parties can access a webcast of the presentation through a provided link, and an archived replay will remain available in the investors section of the company's website for 30 days following the event.
This conference appearance represents an opportunity for Astria to share updates on their development of life-changing therapies with healthcare industry stakeholders and potential investors.
Astria Therapeutics (Nasdaq: ATXS), a biopharmaceutical company, announced its participation in the American Academy of Allergy, Asthma and Immunology (AAAAI) and World Allergy Organization (WAO) Joint Congress in San Diego, California on March 2, 2025.
Three posters will be presented:
- Markus Magerl, M.D., from Charité Universitätsmedizin Berlin, will present the design of the global Phase 3 trial of navenibart (poster 617) titled, “ALPHA-ORBIT – A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Adolescent and Adult Participants with Type 1 and Type 2 Hereditary Angioedema (HAE).”
- Joshua S. Jacobs, M.D., from Allergy and Asthma Clinical Research, Inc., will present attack severity reduction data from the ALPHA-STAR Phase 1b/2 trial of navenibart (poster 606) titled, “Treatment with Navenibart (STAR-0215) Reduces Attack Severity and Use of Rescue Medication in Patients with Hereditary Angioedema (HAE): Interim Results from the ALPHA-STAR Trial.”
- Chunxia Lily Zhao, Ph.D., from Astria Therapeutics, will present information on the profile of STAR-0310 (poster 697) titled, “Preclinical Data Supporting the Differentiated Profile of STAR-0310, a Novel OX40 Antagonistic Monoclonal Antibody.”
All presentations will occur in a poster session titled “Atopic Dermatitis, Contact Dermatitis, Urticaria, Angioedema” starting at 9:45am PST on March 2, 2025, in the Convention Center, Ground Level, Hall A.
Astria Therapeutics (ATXS), a biopharmaceutical company developing therapies for allergic and immunologic diseases, has granted stock options to two new employees under its 2022 Inducement Stock Incentive Plan. The options allow purchase of 16,500 shares at an exercise price of $7.43 per share, matching the closing price on February 3, 2025.
The options will vest over four years, with 25% vesting after the first year of employment and the remaining shares vesting monthly over the following 36 months. These grants comply with Nasdaq Listing Rule 5635(c)(4) for inducement awards to new employees.
Astria Therapeutics (NASDAQ:ATXS), a biopharmaceutical company specializing in allergic and immunologic disease therapies, has announced its upcoming participation in the Oppenheimer 35th Annual Healthcare Life Sciences Conference. The company's CEO, Dr. Jill C. Milne, will engage in a fireside chat on Tuesday, February 11th at 10:40am ET.
The presentation will be accessible via webcast, with a replay available on the company's investor website for 30 days following the event. This virtual conference appearance represents an opportunity for Astria to showcase its developments in life-changing therapies to the investment community.
Astria Therapeutics (NASDAQ:ATXS) has announced its upcoming presentation at the Western Society of Allergy, Asthma & Immunology (WSAAI) Annual Scientific Session in Waimea, Hawaii, scheduled for February 9-13, 2025.
The presentation will focus on quality of life results from the Phase 1b/2 trial of navenibart (STAR-0215). Dr. Marc A. Riedl, Professor of Medicine and Clinical Director of the U.S. HAEA Angioedema Center at UC San Diego, will present an encore poster titled 'Navenibart (STAR-0215) Induces Rapid Improvements of Quality of Life in HAE Patients in the ALPHA-STAR Trial.'
The poster will be on display from 3:00pm ET on February 9 through February 13, 2025.
Astria Therapeutics (NASDAQ:ATXS) has initiated a Phase 1a clinical trial of STAR-0310, a high affinity monoclonal antibody OX40 antagonist for treating atopic dermatitis (AD). The trial will evaluate safety, tolerability, pharmacokinetics, and immunogenicity in approximately 40 healthy adult participants.
The randomized, double-blind, placebo-controlled single ascending dose trial is expected to provide early proof-of-concept results in Q3 2025. Preclinical results show STAR-0310 has significantly less antibody-dependent cellular cytotoxicity compared to rocatinlimab, a competing OX40 antagonist in Phase 3 development. STAR-0310 demonstrates a longer mean half-life of 26 days in cynomolgus monkeys versus 10-14 days for typical non-half-life extended IgG1 antibodies, while maintaining comparable potency to rocatinlimab.
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.
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