BridgeBio Pharma, Inc. (BBIO) on Tuesday said it has submitted a New Drug Application to the U.S. Food and Drug Administration for encaleret as a potential treatment for autosomal dominant hypocalcemia type 1 (ADH1), a rare genetic disorder characterized by low blood calcium levels.
The company said the Phase 3 CALIBRATE trial met all primary and key secondary efficacy endpoints, supporting encaleret's potential as a disease-modifying therapy by targeting the underlying genetic cause of ADH1.
If approved, encaleret would become the first therapy specifically indicated for patients living with ADH1, BridgeBio added.
The company expects a U.S. launch in early 2027 and also plans to initiate the RECLAIM-HP Phase 3 clinical study of encaleret in chronic hypoparathyroidism in summer 2026.
BridgeBio shares closed at $64.68 on Monday, down 4.02%.
For comments and feedback contact: editorial@rttnews.com
Economic News
What parts of the world are seeing the best (and worst) economic performances lately? Click here to check out our Econ Scorecard and find out! See up-to-the-moment rankings for the best and worst performers in GDP, unemployment rate, inflation and much more.
September 04, 2026 15:08 ET The job report and foreign trade data were the main economic news from the U.S. in the first week of September. Elsewhere in North America, the Canadian central bank announced its latest policy decision. Inflation data from Eurozone was the highlight in Europe. The latest interest rate decision by the Reserve Bank of New Zealand drew attention in Asia.