Name in SEC filings: BridgeBio Pharma, Inc.
| Program | Event | Stage | Stated timing | Filing |
|---|---|---|---|---|
| BBP-418 | target date (company stated) | PDUFA | November 27, 2026 | 8-K · |
| infigratinib | submission | — | in the fourth quarter of 2026 | 8-K · |
| infigratinib | PDUFA target date (company stated) | PDUFA | February 4, 2027 | 8-K · |
| encaleret | PDUFA target date (company stated) | PDUFA | May 7, 2027 | 8-K · |
Source: ORION, orionbiotechai.com/company/BBIO, data as of Oct 17, 2026
https://www.orionbiotechai.com/company/BBIO
BBP-418 · PDUFA target date (company stated) · November 27, 2026
SEC sources last checked .
○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.
PDUFA target date (company stated)November 27, 2026
Stage: PDUFASEC filing · “PDUFA date”
Public float: $7,300,000,000 · as of · SEC filing
BBP-418 for limb-girdle muscular dystrophy type 2I/R9, or LGMD2I/R9 (PDUFA date with Priority Review: November 27, 2026)
8-K · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2026-11)
NDA/BLA submissionin the fourth quarter of 2026
Stage: —
Public float: $7,300,000,000 · as of · SEC filing
BridgeBio intends to submit a Marketing Authorization Application (MAA) for achondroplasia to the European Medicines Agency (EMA) in the fourth quarter of 2026.
SEC timing context:
ar; p<0.0001) and its key secondary endpoint of change from baseline in height Z-score (p<0.0001). In a pre-specified exploratory analysis in children younger than 8 years (more than half of participants), oral infigratinib became the first therapeutic option to show a statistically significant improvement in body proportionality against placebo in a randomized achondroplasia trial. Oral infigratinib was well tolerated, with no discontinuations or serious adverse events related to study drug. These data were published as an original research article in The New England Journal of Medicine and simultaneously presented at the International Congress of Children’s Bone Health (ICCBH) 2026 in a late-breaking oral presentation. The results can be found here. Additionally, BridgeBio also shared emerging data for oral infigratinib at ESPE about improvements beyond height for people with achondroplasia, including stabilizing sleep apnea measures, reducing rate of ear infections, and impacting body composition. The results can be found here. “For children and families living with achondroplasia, today’s news represents meaningful progress toward potentially expanding the range of available options,” said Michael Hughes, Chair of the Biotech Industry Liaison Committee at Little People of America. “Our community holds diverse priorities and perspectives, and what matters is that individuals and families have meaningful choices as they consider their own healthcare goals. This milestone brings us one step closer to potentially having another option for families to consider together with their healthcare providers. We appreciate BridgeBio’s continued engagement with the achondroplasia community and its efforts to incorporate community perspectives throughout the development process.” BridgeBio intends to submit a Marketing Authorization Application (MAA) for achondroplasia to the European Medicines Agency (EMA) in the fourth quarter of 2026.
8-K · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2026-12)
PDUFA target date (company stated)February 4, 2027
Stage: PDUFASEC filing · “PDUFA) target action date”
Public float: $7,300,000,000 · as of · SEC filing
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.
8-K · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-02)
PDUFA target date (company stated)May 7, 2027
Stage: PDUFASEC filing · “PDUFA date”
Public float: $7,300,000,000 · as of · SEC filing
encaleret for autosomal dominant hypocalcemia type 1, or ADH1 (PDUFA date with Priority Review: May 7, 2027)
8-K · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-05)
Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of .
| Program / event | Stated period and SEC wording | Disclosure in stated period |
|---|---|---|
| infigratinibSubmission | in the fourth quarter of 2026“BridgeBio intends to submit a Marketing Authorization Application (MAA) for achondroplasia to the European Medicines Agency (EMA) in the fourth quarter of 2026.” Filed · EX-99.1 | Still within period As of Oct 19, 2026 |
| infigratinibFDA decision | February 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.” Filed · EX-99.1 | Period not started The stated period has not started yet, so there is nothing to compare. |
| BBP-418FDA decision | November 27, 2026“BBP-418 for limb-girdle muscular dystrophy type 2I/R9, or LGMD2I/R9 (PDUFA date with Priority Review: November 27, 2026)” Filed · EX-99.1 | Period not started The stated period has not started yet, so there is nothing to compare. |
| encaleretFDA decision | May 7, 2027“encaleret for autosomal dominant hypocalcemia type 1, or ADH1 (PDUFA date with Priority Review: May 7, 2027)” Filed · EX-99.1 | Period not started The stated period has not started yet, so there is nothing to compare. |
| BBP-418FDA decision | November 27, 2026“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.” Filed · 10-Q | Period not started The stated period has not started yet, so there is nothing to compare. |
| encaleretFDA decision | May 8, 2027“The FDA accepted our NDA for filing and assigned a PDUFA target action date of May 8, 2027 for encaleret.” Filed · 10-Q | Period not started The stated period has not started yet, so there is nothing to compare. |
“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.
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