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.
Johnson & Johnson seeks approval for DARZALEX FASPRO in smoldering multiple myeloma
FDA Panel supports IceCure's ProSense Cryoablation for early-stage breast cancer
Dizal submits NDA to US FDA for sunvozertinib in treating NSCLC with EGFR exon 20 mutations
Naitive Technologies enters strategic agreement with Parvizi Surgical Innovation
Akura Medical's application for trial of Katana Thrombectomy System receives US FDA approval
FDA accepts Ionis Pharmaceuticals' donidalorsen New Drug Application
Kazia Therapeutics secures FDA meeting to explore paxalisib pathways for glioblastoma
Boston Scientific to acquire Cortex Inc in strategic expansion of electrophysiology portfolio
Formosa Pharmaceuticals signs licensing agreement with DÁVI Farmaceutica
Amphix Bio receives USD1m SBIR Phase II grant from National Science Foundation