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Bridge announces FDA acceptance of NDA for encaleret in ADH1; PDUFA May 8, 2027

Bridge announced FDA acceptance of its NDA for encaleret for ADH1 with a PDUFA target action date of May 8, 2027.Key Highlights:Original SEC Filing: BridgeBio Pharma, Inc. [ BBIO ] - 8-K - Jul. 22, 2026This is an AI-powered summary. It may contain inaccuracies. Consider verifying important informat…

Bridge announced FDA acceptance of its NDA for encaleret for ADH1 with a PDUFA target action date of May 8, 2027.

Key Highlights:

FDA accepted NDA for encaleret to treat autosomal dominant hypocalcemia type 1 (ADH1), PDUFA date May 8, 2027.
If approved, encaleret would be the first therapy specifically indicated for ADH1, a potential blockbuster opportunity.
CALIBRATE met all pre-specified primary and key secondary endpoints, normalizing CaSR-driven markers without calcium/vitamin D supplements.
FDA does not currently plan an advisory committee meeting; Bridge is prepared to launch upon approval.
Bridge plans EU MAA submission H2 2026 and is enrolling pediatric CALIBRATE-PEDS; RECLAIM-HP Phase 3 for hypoparathyroidism to start later this summer.

Original SEC Filing:

This is an AI-powered summary. It may contain inaccuracies. Consider verifying important information with the source. Please note this summary is solely based on documents filed with the SEC.