European Commission Grants Orphan Medicinal Product Designation for Navenibart, Astria Therapeutics’ Investigational Therapy for the Treatment of Hereditary Angioedema
Astria Therapeutics, Inc. (ATXS)
Company Research
Source: Business Wire
BOSTON--(BUSINESS WIRE)--Astria Therapeutics, Inc. (Nasdaq:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced that the European Commission (EC) 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 to provide long-acting attack prevention for HAE. Initial results from the Phase 1b/2 ALPHA-STAR clinical trial of navenibart have demonstrated a favorable safety and tolerability profile and a reduction of monthly attack rates by 90-96% when dosed once or twice over six months.“We are very pleased to receive Orphan Medicinal Product Designation for navenibart in Europe,” said Jill C. Milne, Ph.D., Chief Executive Officer. “We believe that OMPD status, in combination with the FDA’s designation of navenibart as an orphan drug in the United States, reinforces both t
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ATXS
Earnings
- 11/13/24 - In-Line
ATXS
Sec Filings
- 11/14/24 - Form SC
- 11/14/24 - Form SC
- 11/14/24 - Form SC
- ATXS's page on the SEC website