SignalFDA/Bio
Encaleret Increased Bone Turnover and Improved Participant-Reported Symptoms in the Phase 3 CALIBRATE Trial in ADH1
Phase 3 CALIBRATE trial data show encaleret increased bone turnover and improved symptoms in ADH1.
Context
What happened: BridgeBio Pharma (Nasdaq: BBIO) presented Phase 3 CALIBRATE data showing encaleret increased bone turnover and improved participant-reported ADH1 symptoms, and dosed the first participant in the Phase 3 RECLAIM-HP study.
Key numbers: 100% of encaleret participants reported improvement in at least one ADH1 symptom versus 46% on
Why it matters: The investigator said the bone turnover findings suggest encaleret addresses the underlying biology of ADH1, not just blood calcium. FDA acceptance with Priority Review and an EMA MAA submission advance the regulatory path for encaleret.
Market: +0.6% by next close ($65.75 on Oct 12), -17.0% YTD
What changed
BridgeBio Pharma (Nasdaq: BBIO) presented Phase 3 CALIBRATE data showing encaleret increased bone turnover and improved participant-reported ADH1 symptoms, and dosed the first participant in the Phase 3 RECLAIM-HP study.
Why it matters
The investigator said the bone turnover findings suggest encaleret addresses the underlying biology of ADH1, not just blood calcium. FDA acceptance with Priority Review and an EMA MAA submission advance the regulatory path for encaleret.
Market: +0.6% by next close ($65.75 on Oct 12), -17.0% YTD