Biopharmaceutical company Astria Therapeutics Inc (NASDAQ: ATXS) announced on Monday that it has been granted Orphan Drug Designation by the U.S. FDA for navenibart (STAR-0215), its monoclonal antibody inhibitor of plasma kallikrein, aimed at treating hereditary angioedema (HAE).

Navenibart is designed to prevent HAE attacks through long-acting administration.

Early results from the Phase 1b/2 ALPHA-STAR trial showed a 90-96% reduction in monthly attack rates with once or twice dosing over six months.

The FDA's Orphan Drug program supports therapies targeting rare diseases, providing development incentives to sponsors.

Navenibart also holds Fast Track Designation, positioning it for rapid regulatory progress.