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.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval