Regeneron Announces EMA Accepts Otarmeni for Accelerated Review
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 5 days ago
0mins
Regeneron Pharmaceuticals announced the European Medicines Agency, EMA, has accepted for review under Accelerated Assessment, AA, the Marketing Authorization Application, MAA, for Otarmeni, an in vivo adeno-associated virus vector-based gene therapy for the treatment of biallelic OTOF variant-associated hearing loss. Otarmeni, formerly known as DB-OTO, previously received Orphan Designation from the EMA. If approved, Otarmeni will be the first gene therapy for OTOF-related hearing loss in the European Union, EU. The MAA is supported by data from the pivotal CHORD clinical trial, in which 24 participants received a single dose of Otarmeni via intracochlear infusion, either unilaterally or bilaterally. An earlier cut of results from the CHORD trial also supported the U.S. Food and Drug Administration's recent accelerated approval of Otarmeni in April 2026. Regulatory submissions are planned in additional markets, including Japan.
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Analyst Views on REGN
Wall Street analysts forecast REGN stock price to rise
22 Analyst Rating
16 Buy
6 Hold
0 Sell
Moderate Buy
Current: 634.620
Low
637.00
Averages
808.50
High
1057
Current: 634.620
Low
637.00
Averages
808.50
High
1057
About REGN
Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company. The Company invents, develops, manufactures, and commercializes medicines for people with serious diseases. Its products and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. The Company is accelerating drug development using its proprietary technologies, such as VelociSuite, which produces optimized fully human antibodies and new classes of bispecific antibodies. VelociSuite consists of VelocImmune, VelociGene, VelociMouse, VelociMab, Veloci-Bi, VelociT, VelociHum, and other related technologies. Its marketed products include EYLEA (aflibercept); Dupixent (dupilumab); Libtayo (cemiplimab); Ordspono (odronextamab); Kevzara (sarilumab); Itepekimab; Lynozyfic, and others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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See More
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- Rapid Response: The treatment led to a swift reduction in involved free light chain levels, demonstrating Lynozyfic's effectiveness in eliminating aberrant plasma cells, alongside notable improvements in renal and cardiac function, enhancing its clinical application potential.
- Safety Assessment: While some adverse events were noted, including cytokine release syndrome and infusion-related reactions, these were resolved, and unrelated patient deaths did not impact the overall safety profile, indicating good tolerability of the drug.
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- Clinical Trial Support: The application is backed by data from the pivotal CHORD clinical trial, which evaluated the safety, tolerability, and efficacy of Otarmeni in infants, children, and adolescents, indicating promising clinical outcomes.
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See More
