ApprovalApr 23, 2026187 days ago
FDA grants accelerated approval to Otarmeni for OTOF genetic hearing loss
The FDA approved Regeneron’s Otarmeni (lunsotogene parvec-cwha, DB-OTO) for OTOF-related genetic hearing loss on Apr 23, 2026. The company can now sell it in that market.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
DetailsRegulatory approval
- Company
- Regeneron Pharmaceuticals, Inc. REGN
- Drug
- Otarmeni (lunsotogene parvec-cwha, DB-OTO)
- For
- OTOF-related genetic hearing loss
- Stage
- Pivotal (CHORD) · a study designed to support approval
- When
- Apr 23, 2026
- Source note
- Otarmeni (lunsotogene parvec-cwha) became the first gene therapy approved under the FDA Commissioner's National Priority Voucher program, cleared for severe-to-profound sensorineural hearing loss from biallelic OTOF variants based on week-24 pure tone audiometry from the CHORD trial. Regeneron said it will provide the therapy free in the U.S.
- Checked
- Checked by a person when it was added
Check the sourcesdon’t take our word for it
- Source: stocktitan.net ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- REGN headlines on this site
Regeneron Pharmaceuticals, Inc.
2 upcoming · 5 past catalysts
More from REGN
The FDA is expected to decide in Nov 2026 (no exact date yet) whether to approve Regeneron’s cemdisiran (C5 siRNA) for Generalized myasthenia gravis (anti-AChR antibody-positive). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
More details
- Entry
- PDUFA target action date for cemdisiran in generalized myasthenia gravis · FDA decision due (PDUFA date)
- Drug
- cemdisiran (C5 siRNA)
- For
- Generalized myasthenia gravis (anti-AChR antibody-positive)
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- Nov 2026 · the company gave a window, not a day
- Source note
- FDA accepted the NDA under Priority Review (priority review voucher used) with a target action date in November 2026; announced June 22, 2026. Would be the first siRNA approved in gMG, dosed subcutaneously every 12 weeks.
- Checked
- Checked by a person when it was added
- Verify it
- Source: investor.regeneron.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- REGN headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page