BridgeBio signals 3 launches in next 7 months with BBP-418 November 27 PDUFA and infigratinib February 4, 2027 PDUFA (NASDAQ:BBIO)
Management highlighted FDA decision dates of November 27, 2026, for BBP-418, February 4, 2027, for infigratinib, and May 8, 2027, for encaleret. It expects traditional full approval for infigratinib and does not anticipate that a citizen petition will affect its review timeline or label.