BridgeBio Pharma, Inc. 8K

BridgeBio Pharma, Inc. reported FDA acceptance of its NDA for encaleret for ADH1 with a May 8, 2027 PDUFA date, supporting a potential first-in-class approval and broader development program in related endocrine disorders.

BridgeBio Pharma, Inc. announced that the U.S. Food and Drug Administration has accepted for filing its New Drug Application for encaleret to treat autosomal dominant hypocalcemia type 1 (ADH1), with a Prescription Drug User Fee Act (PDUFA) target action date of May 8, 2027, and indicated it does not currently plan to hold an advisory committee meeting. The NDA is supported by the successful Phase 3 CALIBRATE trial, in which encaleret met all pre-specified primary and key secondary endpoints and demonstrated normalization of key CaSR-driven disease markers with a favorable safety profile, positioning the drug as a potential first and only approved therapy for ADH1 and a potential blockbuster opportunity for the company. BridgeBio is concurrently enrolling CALIBRATE-PEDS, a registrational Phase 2/3 trial in pediatric ADH1, planning to initiate the RECLAIM-HP Phase 3 trial in chronic hypoparathyroidism later in the summer of 2026, and intends to submit a Marketing Authorization Application to the European Medicines Agency for encaleret in ADH1 in the second half of 2026, potentially broadening encaleret’s market and patient reach.

Filing Facts

CIK

1743881

Ticker

BBIO

Form

8K

Source Type

fda

Accession

0001140361-26-029291

Alert Tier

7