Regeneron (REGN) Says EMA Accepted Review for Otarmeni Application

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) is one of the 10 Best Debt-Free S&P 500 Stocks to Buy Now.

On May 22, 2026, Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) announced that the European Medicines Agency accepted for review under Accelerated Assessment the Marketing Authorization Application for Otarmeni, an in vivo adeno-associated virus vector-based gene therapy for biallelic OTOF variant-associated hearing loss. Otarmeni, formerly known as DB-OTO, previously received Orphan Designation from the EMA. If approved, Otarmeni would become the first gene therapy for OTOF-related hearing loss in the European Union. The application is supported by data from the pivotal CHORD trial, where 24 participants received a single dose of Otarmeni through intracochlear infusion.

On May 19, 2026, Canaccord analyst John Newman lowered the firm’s price target on Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) to $875 from $1,057 and maintained a Buy rating on the shares. Newman updated the model after the Phase 3 study of fianlimab+cemiplimab versus pembrolizumab failed to hit statistical significance on the primary endpoint of progression-free survival, calling it a surprising and disappointing event.

Regeneron (REGN) Says EMA Accepted Review for Otarmeni Application

Wolfe Research analyst Alexandria Hammond also lowered the firm’s price target on Regeneron to $860 from $900 and maintained an Outperform rating. Hammond said the company’s LAG-3 trial missed its primary endpoint, while noting that commercial execution will be important and that second-half 2026 catalysts may be underappreciated.

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) discovers, develops, manufactures, and commercializes medicines to treat various diseases worldwide.

While we acknowledge the risk and potential of REGN as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. If you are looking for an AI stock that is more promising than REGN and that has 10,000% upside potential, check out our report about the cheapest AI stock.

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