BridgeBio Announces FDA Acceptance of NDA for Encaleret for ADH1- PDUFA target action date of May 8, 2027 - If approved, encaleret will be the first and only approved therapy specifically indicated for individuals living with ADH1 , representing a potential blockbuster opportunity for BridgeBio - Encaleret demonstrated consistent efficacy across all pre-specified primary and key secondary efficacy endpoints normalizing key markers of CaSR-driven disease biology without the need for calcium and vitamin D supplements, with a favorable safety and tolerability profile - BridgeBio is also currently enrolling CALIBRATE-PEDS, a registrational Phase 2/3 trial to study encaleret in pediatric ADH1 and intends to initiate the RECLAIM-HP Phase 3 registrational study of encaleret in chronic hypoparathyroidism later this summer; successful development could extend encaleret's utility to a broader patient population PALO ALTO, Calif., July 22, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced the FDA has accepted for filing its New Drug Application (NDA) for encaleret for the treatment of individuals living with autosomal dominant hypocalcemia type 1 (ADH1).
GlobeNewsWire7/22/2026Neutral