BBIO BridgeBio Pharma, Inc.
Price Chart
Executive Summary
BridgeBio announced FDA acceptance of its NDA with Priority Review for BBP-418 (LGMD2I/R9), with a PDUFA date of November 27, 2026. The FDA is not planning an advisory committee meeting, and the company is poised to launch upon approval. This is a major regulatory milestone for a first-in-class therapy addressing a significant unmet need in a rare, progressive muscular dystrophy.
Actionable Insight
The Priority Review acceptance and absence of an AdCom are strong positive signals. Monitor for any FDA review updates or potential manufacturing/CMC questions ahead of the November 27 PDUFA. The stock may re-rate upward as approval probability increases. Watch for any competitive developments or regulatory setbacks in Europe.
Key Facts
- FDA accepted NDA for BBP-418 with Priority Review; PDUFA target action date November 27, 2026.
- FDA not currently planning an advisory committee meeting to discuss the application.
- BBP-418 met all primary and secondary endpoints in Phase 3 FORTIFY trial at 12-month interim analysis.
- If approved, BBP-418 would be the first and only approved therapy for LGMD2I/R9 and the first approved treatment for any form of LGMD.
- Approximately 7,000 individuals in the U.S. and Europe live with LGMD2I/R9 and other addressable α-dystroglycanopathies.
- BBP-418 has Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from FDA; may qualify for a Priority Review Voucher upon approval.
- Company intends to initiate clinical studies in patients under 12 years old and in LGMD2M/R13 and LGMD2U/R20.
Financial Impact
First-in-class therapy for ~7,000 patients in U.S./Europe; potential for significant revenue if approved, with pricing typical for rare disease drugs (often $100K-$500K+/year). No financial terms disclosed.
Risk Factors
- FDA could issue a Complete Response Letter (CRL) at PDUFA date, particularly on CMC or safety grounds.
- Commercial uptake depends on pricing, reimbursement, and physician adoption for a novel therapy in a small patient population.
- Clinical data from ongoing pediatric and additional indication studies could reveal safety or efficacy issues.
- Competition from other LGMD therapies in development could emerge.
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3301817 |
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May 27, 2026
13d ago
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Press Release
| $66.44 $63.88 | ▼ −3.85% | ▼ −5.06% | $67.37 (+1.40%) |
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May 26, 2026
14d ago
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Insider Cluster
| $66.44 $65.48 | ▲ +1.44% | ▲ +1.91% | $67.37 (−1.40%) |
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May 21, 2026
19d ago
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144
| $69.12 $65.36 | ▼ −5.44% | ▼ −7.10% | $67.37 (−2.53%) |
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May 19, 2026
21d ago
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Insider Cluster
| $68.22 $68.45 | ▲ +0.34% | ▼ −1.47% | $67.37 (−1.25%) |
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May 12, 2026
28d ago
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Press Release
| $65.95 $65.32 | ▼ −0.96% | ▼ −1.03% | $67.37 (+2.15%) |
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May 11, 2026
29d ago
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Press Release
| $64.68 $65.32 | ▲ +0.99% | ▲ +1.07% | $67.37 (+4.16%) |
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May 8, 2026
4w ago
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S-3ASR
| $67.39 $69.66 | ▲ +3.37% | ▲ +1.90% | $67.37 (−0.03%) |
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May 7, 2026
4w ago
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Press Release
| $67.39 $69.66 | ▲ +3.37% | ▲ +1.90% | $67.37 (−0.03%) |
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May 6, 2026
4w ago
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Press Release
| $68.09 $65.95 | ▼ −3.14% | ▼ −4.27% | $67.37 (−1.06%) |
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May 5, 2026
5w ago
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Press Release
| $68.78 $65.95 | ▼ −4.11% | ▼ −6.10% | $67.37 (−2.05%) |
US Market Status
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