Astria Therapeutics Receives FDA Orphan Drug Designation for Navenibart (STAR-0215) 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 navenibart (STAR-0215) has been granted Orphan Drug Designation for the treatment of hereditary angioedema (HAE) by the U.S. Food and Drug Administration (FDA). 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.“Receiving orphan drug designation for navenibart is an important affirmation of our belief that there is a significant unmet need for people living with HAE,” said Jill C. Milne, Ph.D., Chief Executive Officer. “We believe navenibart has the potential to be the market-leading H
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ATXS
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- 11/13/24 - In-Line
ATXS
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- 11/14/24 - Form SC
- 11/14/24 - Form SC
- 11/14/24 - Form SC
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