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Home/News Feed/FDA accepts BridgeBio's NDA for encaleret to treat ADH1, with approval decision due May 2027
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FDA accepts BridgeBio's NDA for encaleret to treat ADH1, with approval decision due May 2027

Market News
22 Jul 2026
GlobeNewsWire
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Bullish
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BridgeBio Pharma announced the FDA has accepted its New Drug Application for encaleret, a potential first-ever approved treatment for autosomal dominant hypocalcemia type 1 (ADH1). The FDA's target decision date is May 8, 2027, and the drug showed strong efficacy and safety in trials without needing calcium or vitamin D supplements. BridgeBio is also advancing studies for pediatric ADH1 and chronic hypoparathyroidism, aiming to expand encaleret's use. Approval would mark a major breakthrough for ADH1 patients who currently lack indicated therapies.

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BridgeBio Pharma eyes growth with Q2 results and FDA review of new drug encaleret

BridgeBio Pharma eyes growth with Q2 results and FDA review of new drug encaleret

BridgeBio Pharma is set to report its Q2 earnings on August 10, 2026, with analysts expecting $220.91 million in revenue and a loss of $0.63 per share. The FDA recently accepted the New Drug Application for encaleret, targeting a rare genetic conditi...

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