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.
Price Chart
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.
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
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3292712 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Aug 31, 2026 4w ago | 8-K | $76.59 $65.97 | ▼ −13.87% | ▼ −13.68% | $67.47 (−11.90%) |
Aug 26, 2026 5w ago | Press Release | $79.37 $66.28 | ▼ −16.49% | ▼ −16.72% | $67.47 (−14.99%) |
Aug 22, 2026 5w ago | Institutional Cluster | $81.07 $69.23 | ▼ −14.60% | ▼ −15.92% | $67.47 (−16.77%) |
Aug 17, 2026 6w ago | 8-K | $79.89 $72.38 | ▼ −9.40% | ▼ −7.87% | $67.47 (−15.54%) |
Aug 13, 2026 7w ago | Press Release | $79.86 $72.38 | ▲ +9.37% | ▲ +7.38% | $67.47 (+15.51%) |
Aug 10, 2026 7w ago | 8-K | $84.67 $76.08 | ▼ −10.15% | ▼ −9.09% | $67.47 (−20.31%) |
Aug 10, 2026 7w ago | Press Release | $84.67 $76.08 | ▼ −10.15% | ▼ −9.09% | $67.47 (−20.31%) |
Jul 13, 2026 11w ago | Insider Cluster | $83.08 $84.67 | ▲ +1.91% | ▼ −1.27% | $67.47 (−18.78%) |
Jun 28, 2026 13w ago | Press Release | $72.01 $84.02 | ▲ +16.68% | ▲ +16.96% | $67.47 (−6.30%) |
Jun 24, 2026 14w ago | 144 | $69.69 $82.93 | ▲ +19.00% | ▲ +18.47% | $67.47 (−3.18%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Try SecBot Free Coming soon: SecBot Pro with alerts, watchlists, and API access