BBP-418 PDUFA date: FDA decision expected November 27, 2026
The FDA is expected to decide on BBP-418 from BridgeBio Oncology Therapeutics, Inc. by the PDUFA target action date of November 27, 2026. AI-extracted from news: BridgeBio signals 3 launches in next 7 months with BBP-418 November 27 PDUFA and infigratinib Februa
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: seekingalpha.com · Data checked November 12, 2026. How we check dates. Confirm dates against the company's or the FDA's announcement before acting.
Get an email when this FDA date moves or the decision lands
Track BridgeBio Oncology Therapeutics, Inc. (BBOT) and we email you when an FDA date moves, 7 days and 1 day before the decision when the exact day is known, and when it is announced. Free account, no card.
Questions about this FDA decision
- When is the PDUFA date for BBP-418?
- The FDA's PDUFA target action date for BBP-418 is November 27, 2026. The FDA can act before that date, and the review can be extended.
- Which company is developing BBP-418?
- BridgeBio Oncology Therapeutics, Inc. (BBOT).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).