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Home › PDUFA Calendar › BBIO

BBIO PDUFA Date: BBP-418

Updated ·next FDA decision on the calendar
FDA decision (PDUFA) target 2026-11-27 · BridgeBio Pharma Inc. · Limb Girdle Muscular Dystrophy Type 2i (LGMD2i)
More Rare Disease FDA decisions →All November 2026 PDUFA dates →

The story

BBP-418 is under FDA review to treat Limb Girdle Muscular Dystrophy Type 2i (LGMD2i). Balance sheet: about 25 months of cash, runway ~12+ months (company-stated, non-specific) (company-guided).
Full PDUFA calendar ->Every upcoming FDA decision date, by monthNRXP . 2026-07-29Same area: Neurology . KETAFREELNTH-florquinitau . 2026-08-13Same area: Neurology . Florquinitau (MK-6240)BTAI . 2026-11-14Same month decision . IGALMI® (dexmedetomidine)
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

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

$77.93$63.88
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-11-27
Drug / candidateBBP-418
IndicationLimb Girdle Muscular Dystrophy Type 2i (LGMD2i)
CompanyBridgeBio Pharma Inc.
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT05775848 · Fast Track Designation (FTD), Rare Pediatric Disease designation

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See the full 2026 PDUFA calendar →

FAQ

When is the BBIO PDUFA date?
The FDA PDUFA target date for BBIO (BridgeBio Pharma Inc.) is 2026-11-27 for BBP-418. Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is BBIO's drug BBP-418?
BBP-418 is BridgeBio Pharma Inc.'s candidate under FDA review for Limb Girdle Muscular Dystrophy Type 2i (LGMD2i).
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.