BridgeBio Submits NDA to FDA for Encaleret, a Potential First-in-Class Therapy for ADH1

summarizeSummary

BridgeBio Pharma submitted a New Drug Application (NDA) to the FDA for encaleret, a potential first-in-class treatment for autosomal dominant hypocalcemia type 1 (ADH1), following successful Phase 3 clinical trials.

check_boxKey Events · Product Development and Regulatory · BBIO

• NDA Submitted for Encaleret

  BridgeBio Pharma has submitted a New Drug Application (NDA) to the FDA for encaleret, an investigational therapy for autosomal dominant hypocalcemia type 1 (ADH1).

• Successful Phase 3 CALIBRATE Trial

  The Phase 3 CALIBRATE trial met all pre-specified primary and key secondary efficacy endpoints, demonstrating rapid and durable benefits in mineral homeostasis for ADH1 patients.

• Potential First-in-Class Therapy

  Encaleret, if approved, could be the first approved therapy specifically indicated for individuals living with ADH1, addressing the underlying genetic cause of the disease.

• Anticipated Early 2027 U.S. Launch

  BridgeBio anticipates a U.S. launch for encaleret in early 2027, with potential eligibility for priority review by the FDA.

auto_awesomeAnalysis · BBIO · Life Sciences

BridgeBio Pharma has submitted a New Drug Application (NDA) to the FDA for encaleret, a significant step towards commercialization for autosomal dominant hypocalcemia type 1 (ADH1). This submission follows highly positive Phase 3 CALIBRATE trial results, where encaleret demonstrated rapid and durable benefits, meeting all primary and key secondary efficacy endpoints. If approved, encaleret would be the first targeted therapy for ADH1, addressing the underlying genetic cause and potentially launching in early 2027. This milestone significantly de-risks a key pipeline asset and expands the company's potential market opportunity, with plans to also initiate a Phase 3 study for chronic hypoparathyroidism.