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REGN PDUFA Date: Otoferlin gene therapy (DB-OTO)

FDA decision (PDUFA) target 2026-06-30 · Regeneron Pharmaceuticals Inc. · Genetic hearing loss

REGN run-up into the PDUFA (last ~120 days)

$792.16$600.66
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-06-30
Drug / candidateOtoferlin gene therapy (DB-OTO)
IndicationGenetic hearing loss
CompanyRegeneron Pharmaceuticals Inc.
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT05788536 · Fast Track Designation (FTD), Orphan Drug Designation (ODD), Regenerative Medicine Advanced Therapy, Rare Pediatric Disease designation

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FAQ

When is the REGN PDUFA date?
The FDA PDUFA target date for REGN (Regeneron Pharmaceuticals Inc.) is 2026-06-30 for Otoferlin gene therapy (DB-OTO). Dates are company/FDA-sourced and can slip — verify against primary filings.
What is REGN's drug Otoferlin gene therapy (DB-OTO)?
Otoferlin gene therapy (DB-OTO) is Regeneron Pharmaceuticals Inc.'s candidate under FDA review for Genetic hearing loss.
What typically happens to a large-cap stock into a PDUFA date?
Historically, large-cap names had a median decision-day move around ±1% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.