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Home › PDUFA Calendar › REGN

REGN PDUFA Date: Garetosmab

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ Approved · the FDA decided this application on August 19, 2026, 12 days before its August 31, 2026 goal date. Decision page with the source and measured reaction.
FDA decision Approved August 19, 2026 · Regeneron Pharmaceuticals Inc. · Fibrodysplasia Ossificans Progressiva (FOP)
More Rare Disease FDA decisions →All August 2026 PDUFA dates →

The story

Garetosmab was approved by the FDA on August 19, 2026 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 decisionApproved August 19, 2026
FDA goal 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

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See the full 2026 PDUFA calendar →

FAQ

What did the FDA decide on REGN's Garetosmab?
The FDA decided REGN's (Regeneron Pharmaceuticals Inc.) application for Garetosmab on August 19, 2026: Approved. The FDA goal date for this application was 2026-08-31. Verify against the linked primary source.
What is REGN's drug Garetosmab?
Garetosmab is Regeneron Pharmaceuticals Inc.'s drug, approved by the FDA on August 19, 2026 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.