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Home › PDUFA Calendar › REGN

REGN PDUFA Date: Garetosmab

Updated ·next FDA decision on the calendar
FDA decision (PDUFA) target 2026-08-31 · Regeneron Pharmaceuticals Inc. · Fibrodysplasia Ossificans Progressiva (FOP)
More Rare Disease FDA decisions →All August 2026 PDUFA dates →

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.govNot listed
See the full 2026 PDUFA calendar →

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% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · large-cap cohortn=790 · median +0.0% · 50% up
under -30%: 2 of 790 (0%)<-30-30 to -15%: 2 of 790 (0%)-15 to -7%: 6 of 790 (1%)-7 to -3%: 29 of 790 (4%)-3 to +3%: 707 of 790 (89%)±3+3 to +7%: 35 of 790 (4%)+7 to +15%: 5 of 790 (1%)+15 to +30%: 2 of 790 (0%)over +30%: 2 of 790 (0%)>+30
Distribution of next-day % moves after the FDA decision for large-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.