infigratinib — NDA/BLA submission
Q3 2026
The Company intends to submit an NDA to the FDA in the third quarter of 2026, and an MAA to the EMA in the second half of 2026.Source filing
BBIO biotech catalysts & pipeline
BRIDGEBIO PHARMA INC · Data as of 2026-09-08
Upcoming catalysts
oral infigratinib — Interim data
2H 2026
Phase 2 clinical trial update in 2H 2026Source filing
BBP-418 — PDUFA
Nov 27
BBP-418 for limb-girdle muscular dystrophy type 2I/R9, or LGMD2I/R9 (PDUFA date with Priority Review: November 27, 2026);Source filing
Depleter — IND submission
2027
Submit IND to the FDA in 2027Source filing
encaleret — PDUFA
May 7
encaleret for autosomal dominant hypocalcemia type 1, or ADH1 (PDUFA date with Priority Review: May 7, 2027);Source filing
acoramidis — Conference presentation
Nov 6–Nov 9
More data on Attruby will be shared at the American Heart Association (AHA) Congress in November 2025 and in medical congresses throughout 2026.Source filing