BBIO biotech catalysts & pipeline

BRIDGEBIO PHARMA INC · Data as of 2026-10-25

Upcoming catalysts

oral infigratinib — NDA/BLA submission

Q4 2026

BridgeBio intends to submit a Marketing Authorization Application (MAA) for achondroplasia to the European Medicines Agency (E MA) in the fourth quarter of 2026.

Source 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 2027

Source filing

oral infigratinib — PDUFA

Feb 4

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 4, 2027, and BridgeBio is prepared to launch oral infigratinib upon approval.

Source 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

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