BridgeBio says FDA accepts encaleret NDA for ADH1, sets May 8, 2027 PDUFA date

Reuters2026/07/22 11:31

By:Reuters

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BridgeBio’s FDA accepted for filing its NDA for encaleret to treat autosomal dominant hypocalcemia type 1.
PDUFA target action date set for May 8, 2027; the FDA is not currently planning an advisory committee meeting.
The company plans to submit an EMA marketing application in 2H 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BridgeBio Pharma Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202607220730PRIMZONEFULLFEED9766064) on July 22, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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BridgeBio says FDA accepts encaleret NDA for ADH1, sets May 8, 2027 PDUFA date

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