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REGN PDUFA Date: Garetosmab

FDA decision (PDUFA) target 2026-08-31 · Regeneron Pharmaceuticals Inc. · Fibrodysplasia Ossificans Progressiva (FOP)
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The story

Garetosmab is under FDA review to treat Fibrodysplasia Ossificans Progressiva (FOP).
Full PDUFA calendar ->Every upcoming FDA decision date, by monthNVO-sogroya . 2026-06-30Same area: Rare / Genetic . Sogroya (somapacitan)RARE-dtx401-aav-gene . 2026-08-23Same area: Rare / Genetic . DTX401 AAV gene therapy (pariglasgene MRNA . 2026-08-05Same month decision . mRNA-1010
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

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 date2026-08-31
Drug / candidateGaretosmab
IndicationFibrodysplasia Ossificans Progressiva (FOP)
CompanyRegeneron Pharmaceuticals Inc.
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.gov—
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FAQ

When is the REGN PDUFA date?
The FDA PDUFA target date for REGN (Regeneron Pharmaceuticals Inc.) is 2026-08-31 for Garetosmab. Dates are company/FDA-sourced and can slip — verify against primary filings.
What is REGN's drug Garetosmab?
Garetosmab is Regeneron Pharmaceuticals Inc.'s candidate under FDA review for Fibrodysplasia Ossificans Progressiva (FOP).
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.