Watch for the PDUFA decision on February 4, 2027, and any pre-approval inspection or AdCom announcement. Also monitor the MAA submission timeline to EMA in Q4 2026.
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Executive Summary
BridgeBio announced FDA acceptance and Priority Review of its NDA for oral infigratinib for children with achondroplasia, with a PDUFA target action date of February 4, 2027. The filing is a significant regulatory milestone for a potential first-in-class oral therapy, supported by Phase 3 data showing the largest annualized height velocity treatment effect reported in achondroplasia.
Key Facts
- FDA accepted NDA with Priority Review for oral infigratinib in achondroplasia; PDUFA date February 4, 2027.
- PROPEL 3 Phase 3 study met primary endpoint: LS mean treatment difference in AHV of +1.74 cm/yr; mean treatment difference +2.10 cm/yr (p<0.0001).
- First and only therapy to show statistically significant improvement in body proportionality and arm span in a Phase 3 achondroplasia trial.
- Oral infigratinib has Breakthrough Therapy, Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from FDA.
- BridgeBio plans to submit MAA to EMA in Q4 2026 and is prepared for U.S. launch upon approval.
- No discontinuations or serious adverse events related to study drug in PROPEL 3.
Financial Impact
No financial figures provided in the filing. The event is a regulatory milestone for a drug targeting ~55,000 patients in U.S. and EU, with potential to be first approved oral therapy in achondroplasia.
Risk Factors
- FDA may require additional data or deny approval despite Priority Review.
- Competition from other achondroplasia therapies (e.g., vosoritide) could limit market share.
- Commercial launch execution risk if approved.
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001140361-26-039334 |
| Document: ef20083591_ex99-1.htm | 0001140361-26-039334 |
| Document: 0001140361-26-039334-index-headers.html | 0001140361-26-039334 |
| Document: 0001140361-26-039334-index.html | 0001140361-26-039334 |
| Document: 0001140361-26-039334.txt | 0001140361-26-039334 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 27, 2026 today | SC 13G | $68.25 | awaiting T+20 | — | $69.37 (+1.64%) |
Oct 22, 2026 5d ago | Press Release | $68.12 | awaiting T+20 | — | $69.37 (+1.84%) |
Oct 13, 2026 14d ago | 8-K | $63.30 | awaiting T+20 | — | $69.37 (+9.59%) |
Oct 6, 2026 21d ago | Press Release | $66.96 | awaiting T+20 | — | $69.37 (+3.60%) |
Oct 5, 2026 22d ago | Press Release | $66.96 | awaiting T+20 | — | $69.37 (+3.60%) |
Oct 5, 2026 22d ago | Press Release | $66.14 | awaiting T+20 | — | $69.37 (+4.88%) |
Sep 18, 2026 5w ago | Press Release | $66.58 $67.94 | ▲ +2.04% | ▲ +2.95% | $69.37 (+4.19%) |
Aug 31, 2026 8w ago | 8-K | $76.59 $65.97 | ▼ −13.87% | ▼ −13.68% | $69.37 (−9.43%) |
Aug 26, 2026 8w ago | Press Release | $79.37 $66.28 | ▼ −16.49% | ▼ −16.72% | $69.37 (−12.60%) |
Aug 22, 2026 9w ago | Institutional Cluster | $81.07 $69.23 | ▼ −14.60% | ▼ −15.92% | $69.37 (−14.43%) |
US Market Status
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