BBIO PDUFA Date: BBP-418 Updated August 19, 2026 ยท next FDA decision on the calendar FDA decision (PDUFA) target Nov 27, 2026 · BridgeBio Pharma · Limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9)
Key facts FDA PDUFA target date 2026-11-27
Drug / candidate BBP-418 (ribitol)
Indication Limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9)
Company BridgeBio Pharma
Market-cap tier Large
New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs .
See the full 2026 PDUFA calendar → All November 2026 PDUFA dates → FAQ When is the BBIO PDUFA date? The FDA PDUFA target date for BBIO (BridgeBio Pharma) is 2026-11-27 for BBP-418 (ribitol). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is BBIO's drug BBP-418? BBP-418 (ribitol) is BridgeBio Pharma's candidate under FDA review for Limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9).
Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.