BridgeBio Pharma Inc.
BridgeBio Announces FDA Acceptance of NDA for Encaleret for ADH1
Summary
BridgeBio Pharma, Inc. announced that the FDA has accepted its New Drug Application (NDA) for encaleret, a potential treatment for autosomal dominant hypocalcemia type 1 (ADH1). The FDA assigned a PDUFA target action date of May 8, 2027. If approved, encaleret could be the first and only therapy specifically indicated for ADH1, representing a significant market opportunity. BridgeBio is also progressing with clinical trials for encaleret in pediatric ADH1 and chronic hypoparathyroidism.
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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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