Garetosmab - (OPTIMA)

April 29, 2026: Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported Q1 2026 results and provided pipeline/regulatory updates. Key recent catalysts included FDA and EC approvals for Dupixent (dupilumab) for chronic spontaneous urticaria (CSU) in children aged 2–11; Japan MHLW approval for Dupixent in adults with moderate-to-severe bullous pemphigoid (EU application under review); and FDA approval of Dupixent for allergic fungal rhinosinusitis (AFRS) in patients ≥6 years. The FDA also approved extending EYLEA HD (aflibercept 8 mg) dosing intervals up to every 20 weeks (5 months) for wet AMD and DME after one year of successful response. For the EYLEA HD pre-filled syringe (PFS), Regeneron resubmitted an application for Catalent Indiana filling, and the FDA did not act by the April 2026 PDUFA date on a second contract manufacturer PFS application; the company expects a regulatory decision on one or both in Q2 2026.

In April 2026, the FDA granted accelerated approval to Otarmeni (lunsotogene parvec; formerly DB-OTO) for severe-to-profound hearing loss due to OTOF variants; Regeneron will provide it free in the U.S.

Upcoming/readouts/filings: Phase 3 fianlimab + cemiplimab vs pembrolizumab in 1L metastatic melanoma results expected in Q2 2026; adjuvant melanoma Phase 3 continues (second interim and possible final analyses anticipated 2H 2026); Phase 2 NSCLC data did not support Phase 3. Regeneron submitted an NDA for cemdisiran in myasthenia gravis (voucher used); acceptance anticipated Q2 2026 and FDA decision expected Q4 2026. FDA accepted for priority review the garetosmab BLA in FOP with an August 2026 target action date (EU review ongoing). Phase 3 trials were initiated for REGN7508/REGN9933 (Factor XI) and for mibavademab in monogenic obesity.