BridgeBio Doses First Patient as Phase 3 Encaleret Data Debuts

BridgeBio Pharma advanced its clinical pipeline by presenting Phase 3 trial data for encaleret in autosomal dominant hypocalcemia type 1 and dosing its first patient in a separate hypoparathyroidism study.

The regulatory milestones arrive as BridgeBio Pharma Inc. (NASDAQ: BBIO) trades at $66.39, down 1.10% from its previous close of $67.13 as of October 16, 2026, according to Finnhub market data.

Phase 3 CALIBRATE Trial Results

Results from the Phase 3 CALIBRATE trial demonstrated that encaleret successfully stimulated endogenous parathyroid hormone secretion to at or above the lower limit of normal in 91% of participants at 24 weeks. By comparison, 0% of patients on standard of care achieved the same physiological benchmark.

Symptom relief was also a primary endpoint measured during the evaluation. According to reporting from Investing.com, 100% of participants receiving encaleret reported improvements in at least one ADH1 symptom, compared to 46% of patients managed on standard of care.

Expanding Into Chronic Hypoparathyroidism

Following the ADH1 data release, BridgeBio dosed the first participant in RECLAIM-HP. RECLAIM-HP is a separate Phase 3 study designed to evaluate the efficacy and safety of encaleret in adults and adolescents diagnosed with chronic hypoparathyroidism.

Hypoparathyroidism is a rare endocrine disorder characterized by insufficient levels of parathyroid hormone, leading to low blood calcium and elevated phosphorus levels. Traditional management typically relies on calcium and active vitamin D supplements, which frequently fail to adequately control the condition and can cause renal complications over time.

Regulatory Review Timeline

Regulatory agencies in major markets are actively reviewing the therapy. The U.S. Food and Drug Administration accepted BridgeBio's new drug application for encaleret in ADH1, granting it Priority Review with a target action date of May 8, 2027.

Concurrently, a marketing authorization application has been submitted to the European Medicines Agency for review across member states, positioning the compound for potential commercialization across North America and Europe.