BioPharmSignal logoBioPharmSignal

Biotech News

Otarmeni™ (lunsotogene parvec-cwha) Approved by FDA as First and Only Gene Therapy for Genetic Hearing Loss; Regeneron to Provide Otarmeni for Free in the U.S.

Regeneron Pharmaceuticals (REGN)Regeneron PharmaceuticalsFDA / regulatory

Approval in severe-to-profound and profound OTOF -related hearing loss is based on pivotal results of the CHORD trial demonstrating 80% of participants achieved or surpassed a hearing level meeting the primary endpoint, and with longer follow-up, 42% achieved normal hearing that included whispers

Open original release

Related news

REGNRegeneron Pharmaceuticals2026-05-22 11:00 EST

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

ARGXArgenx2026-05-08 21:20 EST

argenx Announces U.S. FDA Approval Expanding VYVGART and VYVGART Hytrulo for Use in All Adult Patients Living with gMG

BMYBMYBristol-Myers Squibb Company2026-07-13 10:59 EST

U.S. Food and Drug Administration Accepts Bristol Myers Squibb's New Drug Application for Mezigdomide in Patients with Relapsed or Refractory Multiple Myeloma

INBXInhibrx2026-06-15 13:15 EST

Inhibrx Announces U.S. FDA Acceptance of BLA for Ozekibart in Patients with Conventional Chondrosarcoma

REGNRegeneron Pharmaceuticals2026-05-28 20:00 EST

Regeneron’s Ebola Antibody Recommended by World Health Organization for Investigational Use in Response to Current Bundibugyo Ebolavirus Outbreak

COGTCogent Biosciences2026-05-28 12:00 EST

Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GIST

GSKGSK plc2026-05-18 07:00 EST

GSK’s RSV vaccine, Arexvy, receives expanded approval in Japan for adults aged 18–59 at increased risk

BMYBMYBristol-Myers Squibb Company2026-05-08 10:59 EST

Bristol Myers Squibb Receives European Commission Approval of Sotyktu (deucravacitinib) for the Treatment of Active Psoriatic Arthritis in Adults

REPLReplimune Group2026-05-29 12:00 EST

Replimune Announces Planned RP1 BLA Resubmission Following Productive Discussion with FDA

IMVTImmunovant2026-07-23 20:05 EST

Immunovant to Report Financial Results for the First Quarter Ended June 30, 2026, and Provide Business Update on Thursday, August 6, 2026

View all latest news

Regeneron Pharmaceuticals

Regeneron is a biotechnology company built around antibody discovery, biologics development, and marketed therapies across eye disease, immunology, and oncology. The company’s platform and R&D engine make it one of the most scientifically respected names in public biotech.

Recent company news

REGNRegeneron Pharmaceuticals2026-06-04 11:00 EST

Regeneron to Highlight Progress Across Its Metabolic Disease, Ophthalmology and Rare Disease Pipelines at ADA and ENDO

REGNRegeneron Pharmaceuticals2026-05-28 20:00 EST

Regeneron’s Ebola Antibody Recommended by World Health Organization for Investigational Use in Response to Current Bundibugyo Ebolavirus Outbreak

REGNRegeneron Pharmaceuticals2026-05-22 11:00 EST

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

REGNRegeneron Pharmaceuticals2026-05-21 21:01 EST

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

REGNRegeneron Pharmaceuticals2026-05-18 11:00 EST

Regeneron Announces Strategic Collaboration with Parabilis Medicines to Advance Novel Antibody-Helicon™ Conjugates Across Multiple Therapeutic Areas

Stock data

Close
667.17 USD
Market cap
63.21B USD
Exchange
NASDAQ
Sector
Antibody Drugs, Biopharma
Location
United States