FDA accepts BridgeBio's NDA for encaleret in ADH1
The agency set a PDUFA target action date of May 8, 2027, and does not currently plan an advisory committee meeting.
BridgeBio Pharma announced on July 22, 2026 that the FDA has accepted for filing its New Drug Application for encaleret for the treatment of individuals living with autosomal dominant hypocalcemia type 1 (ADH1).1 The company said that if approved, encaleret will be the first and only approved therapy specifically indicated for individuals living with ADH1, representing what BridgeBio called a potential blockbuster opportunity.1
The FDA has assigned a Prescription Drug User Fee Act target action date of May 8, 2027, and BridgeBio said it is prepared to launch encaleret upon approval.1 The agency also told the company it is not currently planning to hold an advisory committee meeting to discuss the application.1
The filing rests on the Phase 3 "CALIBRATE" trial. BridgeBio said the trial met all pre-specified primary and key secondary efficacy endpoints, which the company said supports the drug's potential as a disease-modifying therapy that targets the underlying genetic cause of ADH1.1 Additional results presented at the European Congress of Endocrinology 2026 and the Endocrine Society's 2026 annual meeting showed simultaneous restoration of blood and urine calcium, along with restoration of physiologic parathyroid hormone production.1
On the diagnostic landscape, as of April 2026, over 2,100 individuals had been diagnosed in the U.S. with autosomal dominant hypocalcemia since October 2023, based on claims data, which the company said suggests a growing marketplace and elevated diagnostic suspicion.1 BridgeBio also said it intends to file a Marketing Authorization Application with the European Medicines Agency for encaleret in ADH1 during the second half of 2026.1
On the pipeline, BridgeBio is currently enrolling "CALIBRATE-PEDS" (NCT07080385), a global registrational Phase 2/3 study of encaleret in pediatric ADH1.1 The company also plans to start "RECLAIM-HP," a global Phase 3 study of encaleret in chronic hypoparathyroidism, later this summer, building on earlier Phase 2 proof-of-concept findings on PTH-independent effects of encaleret on renal calcium handling.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.