BBIO BridgeBio Pharma, Inc.
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Executive Summary
BridgeBio announced NDA submission to the FDA for encaleret in ADH1, supported by positive Phase 3 CALIBRATE data showing 76% of patients achieved target calcium levels vs 4% on standard of care (p<0.0001). If approved, encaleret would be the first approved therapy for ADH1, with a potential U.S. launch in early 2027 and an estimated diagnosed patient population of ~2,000 in the U.S.
Actionable Insight
NDA submission with strong Phase 3 data de-risks encaleret's approval path for ADH1. Watch for FDA acceptance and priority review decision, which could accelerate timeline. Expansion into chronic hypoparathyroidism (RECLAIM-HP) represents a larger market opportunity. Monitor for any FDA advisory committee meeting or CRL risk.
Key Facts
- NDA submitted to FDA for encaleret in autosomal dominant hypocalcemia type 1 (ADH1)
- Phase 3 CALIBRATE trial met all primary and key secondary endpoints
- 76% of encaleret patients achieved target serum and urine calcium vs 4% on conventional therapy (p<0.0001)
- Encaleret restored endogenous PTH in 91.1% of patients vs 0% on standard of care at Week 24
- No discontinuations in encaleret arm; favorable safety profile
- Potential first approved therapy for ADH1; U.S. launch anticipated early 2027
- Nearly 2,000 diagnosed ADH patients in U.S. since Oct 2023 based on claims data
- MAA submission to EMA planned for H2 2026
- Phase 2/3 pediatric study (CALIBRATE-PEDS) enrolling; Phase 3 chronic hypoparathyroidism study (RECLAIM-HP) planned for Summer 2026
- Fast Track and Orphan Drug designations from FDA; Orphan in EU and Japan
Financial Impact
First-to-market therapy for ADH1 with ~2,000 diagnosed U.S. patients; potential expansion to chronic hypoparathyroidism (larger market). No revenue guidance provided.
Risk Factors
- FDA may not accept NDA or may issue Complete Response Letter
- ADH1 is ultra-rare (~2,000 diagnosed patients) limiting peak revenue potential
- Competition from existing calcium/vitamin D therapies and potential future entrants
- Regulatory delays or additional clinical data requirements
- Commercial execution risk in a rare disease with small prescriber base
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3292712 |
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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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| $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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