BridgeBio Pharma, Inc. BBIO
BridgeBio Pharma, Inc. (Nasdaq: BBIO) is a cardio-renal-metabolic drug developer. Its lead program, Attruby (acoramidis), is in Phase 3 for transthyretin amyloid cardiomyopathy. Its next catalyst on record is encaleret: FDA action on ADH1 NDA (May 2027).
Upcoming catalysts
- May 2027encaleret — FDA action on ADH1 NDA
PDUFA target 2027-05-08 (per 10-Q)
Next further out: oral infigratinib — BridgeBio intends to submit MAA for oral infigratinib in achondroplasia to EMA in fourth quarter of 2026. (Q4 2026). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Attruby (acoramidis) | ATTR-CM | small molecule | Approved |
| BBP-418 | LGMD2I/R9 | small molecule | Phase 3 |
| encaleret | ADH1 | small molecule | Phase 3 |
| infigratinib | achondroplasia | small molecule | Phase 3 |
| encaleret | hypoparathyroidism | small molecule | Phase 3 |
Recent results and decisions
- Oct 6, 2026accepted FDA accepted the NDA for oral infigratinib in pediatric achondroplasia with Priority Review and a PDUFA date of Feb 4, 2027.
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.
Filing - Oct 6, 2026met PROPEL 3 met its primary endpoint: annualized height velocity +2.10 cm/yr vs placebo at Week 52 (p<0.0001); previously reported, now published in NEJM.
PROPEL 3 met its primary endpoint and key secondary endpoints, delivering the strongest efficacy package reported to date in achondroplasia
Filing - Aug 10, 2026submitted NDA for oral infigratinib in achondroplasia submitted to FDA; PDUFA date not yet set; U.S. launch expected mid-2027.
The Company submitted an NDA to the FDA for oral infigratinib in achondroplasia and is on track to submit an MAA to the EMA in the fourth quarter of 2026.
Filing
15 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 cardio-renal-metabolic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.