Otarmeni™ (lunsotogene parvec) Receives EMA Filing Acceptance for Genetic Hearing Loss

(NASDAQ: REGN) today announced the European Medicines Agency (EMA) has accepted for review under Accelerated Assessment the Marketing Authorization Application (MAA) for Otarmeni™ (lunsotogene parvec) ...

Lynozyfic® (linvoseltamab) Monotherapy Demonstrates Deep and Rapid Responses in All Treated Patients with Second-Line-Plus Systemic Amyloid Light Chain Amyloidosis

Normalization of free light chains occurred by day 15 across all doses 100% of patients achieved a hematologic complete response (CR) at the ...
Precision Medicine Online

EMA to Review Regeneron's Otarmeni for Rare Form of Genetic Hearing Loss

The EMA accepted Regeneron's marketing authorization application for the gene therapy and will review it under accelerated assessment.
Nasdaq

Regeneron Pharmaceuticals Reports Promising Phase 3 Trial Results for Libtayo in High-Risk Cutaneous Squamous Cell Carcinoma

Regeneron Pharmaceuticals announced promising results from the Phase 3 C-POST trial of Libtayo (cemiplimab), a PD-1 inhibitor for patients with high-risk cutaneous squamous cell carcinoma (CSCC) ...