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BridgeBio Pharma Inc. (NASDAQ:BBIO) released topline results from the CALIBRATE Phase 3 study of encaleret in autosomal dominant hypocalcemia type 1 (ADH1) on Wednesday. ADH1 is a genetic disorder causing low blood calcium with inappropriately low parathyroid hormone (PTH) levels. BBIO stock is at important technical levels. See what is driving the move here Autosomal dominant hypocalcemia is characterized by low levels of calcium in the blood (hypocalcemia) Encaleret is an investigational, orally-administered, negative allosteric modulator of the calcium-sensing receptor (CaSR). Also Read: BridgeBio’s Acoramidis Cuts Risk Within Weeks In Rare Heart Condition Data The primary endpoint was the proportion of participants randomized to receive encaleret achieving both serum calcium and urine calcium. 76% of encaleret-treated participants (34 of 45) achieved the primary endpoint compared to 4% for these participants (2 of 45) while on conventional therapy. The pre-specified key secondary analyses comparing encaleret to standard of care included a between-group comparison on the proportion of participants achieving both target albumin-corrected serum and urine calcium, and comparisons of intact PTH above the lower limit of the reference range. None of the encaleret responders at Week 24 required conventional therapy during Period 31. Encaleret was well-tolerated. Of the 67 randomized participants, 65 (97%) elected to continue in the ongoing long-term extension of the study. What Next? The company intends to submit its New Drug Application (NDA) to the FDA in the first half of 2026, and a Marketing Authorization Application to the European Medicines Agency to follow. In addition, BridgeBio plans to initiate a registrational trial of encaleret in pediatric ADH1 in the first quarter of 2026 and a Phase 3 study of encaleret in adults with chronic hypoparathyroidism in 2026. BBIO Price Action: BridgeBio Pharma shares were up 4.72% at $67.54 at the time of publication on Wednesday. The stock is trading at a new 52-week high, according to Benzinga Pro data. Read Next: Elon Musk Touts Tesla’s Autonomous Driving Tech Despite Robotaxi Rollback, NHTSA Probe: ‘Might Spread Faster Than Any Technology Ever Photo by PeopleImages.com – Yuri A via Shutterstock
