BridgeBio Pharma Inc.
BridgeBio Submits NDA to FDA for Encaleret for ADH1 Treatment
Summary
BridgeBio Pharma, Inc. has submitted a New Drug Application (NDA) to the FDA for encaleret, a potential treatment for autosomal dominant hypocalcemia type 1 (ADH1). The NDA submission is based on the successful results of the Phase 3 CALIBRATE trial, which met all primary and key secondary efficacy endpoints. The trial demonstrated that 76% of participants achieved target serum and urine calcium levels with encaleret, compared to 4.4% on standard of care. BridgeBio anticipates a U.S. launch in early 2027 and plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the second half of 2026.
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About BridgeBio Pharma Inc.
BridgeBio Pharma Inc. is a cutting-edge biotechnology company focused on discovering, developing, and delivering transformative medicines for patients with genetic diseases. The company's primary purpose is to bridge the gap in medical research and bring breakthrough therapies to those with rare and often overlooked genetic disorders. By utilizing a targeted approach, BridgeBio Pharma Inc. works across multiple sectors including dermatology, oncology, cardiology, neurology, and endocrinology. The company partners with academic institutions, research organizations, and industry leaders to harness the latest scientific advancements in genomics and biotechnology. Established with a mission to translate genetic research into real-world medical solutions, BridgeBio Pharma Inc. plays a significant role in the biopharmaceutical market. It is heavily involved in the early and late stages of drug development, positioning itself as a key player in the quest to address unmet medical needs. This focus on genetic-centric therapies underlines its importance in the rapidly evolving landscape of biotechnology and personalized medicine.
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