Friday, Regeneron Pharmaceuticals, Inc. (REGN) announced that Otarmeni has been accepted by European Medicines Agency for review under Accelerated Assessment the Marketing Authorization Application for the treatment of biallelic OTOF variant-associated hearing loss.
The application is backed by data from the pivotal CHORD clinical trial, evaluating the safety, tolerability and efficacy of Otarmeni in infants, children and adolescents with OTOF-related hearing loss.
If approved, Otarmeni will be the first gene therapy for OTOF-related hearing loss in the European Union.
Earlier, Otarmeni received Orphan Designation from the European Medicines Agency.
In the pre-market hours, REGN is trading at $645.00, up 0.38 percent on the Nasdaq.
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Business News
May 15, 2026 15:25 ET Apart from the confirmation of Kevin Warsh as the next Fed chair, the main news on the economics front this week included key price data from the U.S. and the first quarter economic growth figures from major economies. Both consumer prices and producer costs have started to reflect the effect of supply shocks due to the Middle East conflict. In Europe, GDP data was in focus, while inflation data from China dominated the news flow in Asia.