Encaleret Phase 3 Data Show 100% Symptom Improvement in ADH1; RECLAIM-HP Doses First Patient
BBIO sits 24% above its 52-week low of $52.75.
Summary
BridgeBio presented 24-week Phase 3 CALIBRATE data showing encaleret restored endogenous PTH secretion in 91% of ADH1 patients versus 0% on standard of care, with 100% of treated participants reporting improvement in at least one symptom compared to 46% on SoC. The company also dosed the first patient in RECLAIM-HP, a registrational Phase 3 trial for chronic hypoparathyroidism. These results strengthen the case for encaleret's approval in ADH1, where an NDA is already under Priority Review with a PDUFA date of May 8, 2027. The data also support expansion into the larger chronic hypoparathyroidism market, estimated at over 200,000 patients in the US and EU. The bone turnover and patient-reported outcomes go beyond the previously reported primary endpoint, adding mechanistic and quality-of-life evidence that could differentiate encaleret from conventional therapy.
At the time of this announcement, BBIO was trading at $65.35 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $12.8B. The 52-week trading range was $52.75 to $93.42. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.