BridgeBio submits FDA application for rare disease drug encaleret

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BridgeBio Submits NDA to FDA for Encaleret for Individuals Living with ADH1

May 12, 2026 7:30 AM EDT

- Phase 3 CALIBRATE primary results were presented in an oral presentation at the 2026 ECE, demonstrating the rapid and durable benefit of encaleret across key clinical parameters in ADH1 

- All pre-specified primary and key secondary efficacy endpoints were met in the Phase 3 CALIBRATE trial; 76% of participants administered... More