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 (ATXS) is a biopharmaceutical innovator developing monoclonal antibody therapies for rare immunological conditions like hereditary angioedema and atopic dermatitis. This page aggregates all official company announcements and verified news updates for stakeholders tracking its preclinical pipeline and scientific advancements.
Investors and researchers will find timely updates on clinical developments, regulatory milestones, and strategic partnerships. Our curated feed includes progress reports on key candidates like plasma kallikrein inhibitors and OX40 antagonists, along with analyses of their potential impact on underserved patient populations.
Content spans trial design announcements, patent filings, executive commentary, and peer-reviewed research collaborations. All materials are vetted for accuracy and presented in chronological order to help users track the company's evolving position in the rare disease therapeutics market.
Bookmark this page for streamlined access to ATXS's latest scientific disclosures and corporate developments. Check regularly for updates on antibody engineering breakthroughs and preclinical validation studies shaping the future of immune disorder treatments.
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.
Astria Therapeutics (Nasdaq:ATXS) announced that navenibart (STAR-0215) has received FDA Orphan Drug Designation 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 and tolerability profile
- 90-96% reduction in monthly attack rates with one or two doses over six months
Astria believes navenibart could become the market-leading HAE treatment due to its efficacy and infrequent dosing. The company plans to share additional ALPHA-STAR trial results in Q4 and initiate a Phase 3 trial in Q1 2025. The FDA's Orphan Drug Designation provides development and commercial incentives for rare disease treatments affecting fewer than 200,000 people in the US.
Astria Therapeutics (Nasdaq:ATXS), a biopharmaceutical company focused on allergic and immunologic diseases, announced that leading HAE experts will present two posters at the Global Angioedema Forum (GAF) in Copenhagen, Denmark on October 4-5, 2024.
Dr. Aleena Banerji, Associate Professor of Medicine at Harvard Medical School, will present on the ALPHA-SOLAR trial of navenibart (STAR-0215) for HAE in an encore poster titled “Rationale and Design of the ALPHA-SOLAR Clinical Trial of STAR-0215” on October 4 at 6:00pm CEST.
Dr. William Lumry, Clinical Professor of Internal Medicine at the University of Texas Health Science Center, will present results from the Phase 1b/2 trial of navenibart (STAR-0215) in an encore poster titled “ALPHA-STAR, a Phase 1b/2 Clinical Trial of Single and Multiple Doses of STAR-0215 in Patients with Hereditary Angioedema: Initial Safety and Efficacy Outcomes” during a session titled “Emerging Treatment Options” on October 5 at 9:30am CEST.
Astria Therapeutics (Nasdaq:ATXS) has announced its upcoming presentation at the European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam on September 26, 2024. The company will showcase initial data from the ALPHA-STAR trial of navenibart, their treatment for hereditary angioedema.
Dr. Raffi Tachdjian from UCLA will present a poster titled 'ALPHA-STAR, a Phase 1b/2 Clinical Trial of Single and Multiple Doses of STAR-0215 in Patients with Hereditary Angioedema: Initial Safety and Efficacy Outcomes' during the e-poster showcase six at 4:20pm CEST. This presentation marks an important milestone for Astria Therapeutics in their development of therapies for allergic and immunologic diseases.
Astria Therapeutics (Nasdaq: ATXS), a biopharmaceutical company focused on allergic and immunologic diseases, has granted stock options to three new employees under its 2022 Inducement Stock Incentive Plan. The options, totaling 180,000 shares, were issued on September 3, 2024, with an exercise price of $11.46 per share, matching the closing price on the grant date.
These options will vest over four years, with 25% vesting after one year and the remainder vesting monthly over the following 36 months. The grants comply with Nasdaq Listing Rule 5635(c)(4) for inducement material to new employees. This plan is exclusively used for equity awards to individuals not previously employed by Astria.
Astria Therapeutics (NASDAQ:ATXS) is set to present two posters at the Bradykinin Symposium in Berlin on September 6, 2024. The presentations focus on navenibart (STAR-0215), a potential therapy for Hereditary Angioedema (HAE).
Dr. Chris Morabito, Chief Medical Officer, will present on the ALPHA-SOLAR trial, a long-term open-label study of navenibart in HAE patients. Kusumam Joseph, Senior Director of Medical Affairs, will share updated results from the Phase 1a trial of navenibart.
These presentations highlight Astria's progress in developing treatments for allergic and immunologic diseases, particularly HAE. The symposium provides a platform for Astria to showcase its advancements in bradykinin-related therapies to the scientific community.
Astria Therapeutics (Nasdaq: ATXS), a biopharmaceutical company specializing in allergic and immunologic diseases, has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference. The event is scheduled for September 5th in New York City.
This conference provides Astria Therapeutics with a platform to showcase its progress in developing life-changing therapies and potentially connect with investors and industry professionals. The company's attendance at such a prestigious healthcare conference highlights its commitment to advancing its research and development efforts in the field of allergic and immunologic diseases.
Astria Therapeutics (NASDAQ:ATXS) reported Q2 2024 financial results and provided a corporate update. Key highlights:
1. Navenibart (STAR-0215) for HAE treatment is on track for Phase 3 initiation in Q1 2025.
2. Preclinical results support STAR-0310 as a potential best-in-class OX40 inhibitor.
3. Cash position of $354.7 million as of June 30, 2024, expected to fund operations into mid-2027.
4. Q2 2024 net loss of $24.2 million ($0.43 per share) compared to $12.6 million ($0.45 per share) in Q2 2023.
5. R&D expenses increased to $20.7 million in Q2 2024 from $9.1 million in Q2 2023.
Astria Therapeutics (NASDAQ:ATXS) has chosen Ypsomed as its partner to develop an autoinjector for STAR-0215, a therapy for Hereditary Angioedema (HAE). The collaboration aims to support Astria's goal of offering patients a choice between infrequent three- and six-month administration options. Astria plans to launch STAR-0215 with both the Ypsomed YpsoMate autoinjector and a pre-filled syringe, pending regulatory approval. The autoinjector is considered ideal for STAR-0215 due to its ease of use, needle shielding feature, and quick injection with low risk of pain. This partnership aligns with Astria's vision of providing effective HAE attack protection while minimizing treatment burden.
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