The European Medicines Agency (EMA) has accepted Regeneron Pharmaceuticals' Marketing Authorization Application for Otarmeni (lunsotogene parvec), a gene therapy targeting biallelic OTOF variant-associated hearing loss, for accelerated assessment. Otarmeni, already approved in the U.S., could become the first gene therapy for this ultra-rare genetic hearing loss in the EU. The application is supported by positive data from the CHORD clinical trial involving children and adolescents. Regulatory submissions are planned for other markets, including Japan, signaling potential global availability soon.
Regeneron Pharmaceuticals is under investigation by Pomerantz LLP following disappointing Phase 3 trial results for its melanoma treatment, which failed to show significant improvement over existing therapy. The news led to a nearly 10% drop in Regen...
Regeneron's Lynozyfic (linvoseltamab) monotherapy achieved a 100% hematologic complete response in patients with second-line-plus systemic amyloid light chain (AL) amyloidosis in the Phase 1/2 LINKER-AL2 trial. The drug normalized free light chains b...
