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 amyloidosis (ATTR-CM). Its next catalyst on record is BBP-418: PDUFA target action date (November 27, 2026).
Upcoming catalysts
- November 27, 2026BBP-418 — PDUFA target action date
The FDA accepted our NDA for filing, granted Priority Review and assigned a Prescription Drug User Fee Act ("PDUFA") target action date of November 27, 2026, for BBP-418.
- November 27, 2026BBP-418 — BBP-418 for LGMD2I/R9 has a PDUFA date of November 27, 2026, with Priority Review.
BBP-418 for LGMD2I/R9 has a November 27, 2026 PDUFA date, with Priority Review.
- November 2026BBP-418 — FDA action on NDA (priority review)
On May 27, 2026, the FDA accepted our NDA for filing, granted Priority Review and assigned a Prescription Drug User Fee Act ("PDUFA") target action date of November 27, 2026 for BBP-418.
- November 2026BBP-418 — BBP-418 for LGMD2I/R9 has a November 27, 2026 PDUFA date with Priority Review.
BBP-418 for LGMD2I/R9 has a November 27, 2026 PDUFA date, with Priority Review.
- February 4, 2027Infigratinib — PDUFA target action date
The FDA accepted our NDA for filing, granted Priority Review and assigned a PDUFA target action date of February 4, 2027, for infigratinib.
- February 4, 2027oral infigratinib — Oral infigratinib for achondroplasia has a PDUFA date of February 4, 2027, with Priority Review.
Oral infigratinib for achondroplasia has a February 4, 2027 PDUFA date, with Priority Review.
- February 2027Oral infigratinib — Oral infigratinib for achondroplasia has a February 4, 2027 PDUFA date with Priority Review.
Oral infigratinib for achondroplasia has a February 4, 2027 PDUFA date, with Priority Review.
- May 8, 2027Encaleret — PDUFA target action date
The FDA accepted our NDA for filing, granted Priority Review and assigned a PDUFA target action date of May 8, 2027, for encaleret.
- May 8, 2027encaleret — Encaleret for ADH1 has a PDUFA date of May 8, 2027, with Priority Review.
Encaleret for ADH1 has a May 8, 2027 PDUFA date, with Priority Review
- May 2027encaleret — FDA action on ADH1 NDA
PDUFA target 2027-05-08 (per 10-Q)
- May 2027Encaleret — Encaleret for ADH1 has a May 8, 2027 PDUFA date with Priority Review.
Encaleret for ADH1 has a May 8, 2027 PDUFA date, with Priority Review, and the MAA is under EMA review with potential EU approval in the second half of 2027.
Next further out: infigratinib — The MAA for infigratinib in achondroplasia is under EMA review with potential EU approval in the second half of 2027. (H2 2027). 9 catalysts 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 |
| Infigratinib | Hypochondroplasia | small molecule | Phase 2 |
| Acoramidis | Primary prevention in asymptomatic TTR variant carriers | small molecule | Phase 2 |
Recent results and decisions
- Oct 29, 2026started First participant dosed in RECLAIM-HP, the Phase 3 study for encaleret in chronic hypoparathyroidism.
The first participant was dosed in RECLAIM-HP, the Phase 3 study for encaleret in chronic hypoparathyroidism.
Filing - Oct 29, 2026started First participant dosed in ASCEND-ATTR, the Phase 3b/4 study to prospectively test disease reversal with Attruby.
The first participant was dosed in ASCEND-ATTR, the Phase 3b/4 study to prospectively test disease reversal with Attruby.
Filing - Oct 29, 2026n/a BBP-418 for LGMD2I/R9 has PDUFA date of November 27, 2026, with Priority Review.
BBP-418 for LGMD2I/R9 has a November 27, 2026 PDUFA date, with Priority Review.
Filing
24 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.