BridgeBio Posts Two Positive Phase 3 Results

BridgeBio reported positive Phase 3 results for two late‑stage candidates: encaleret and BBP‑418 (ribitol). In the Phase III CALIBRATE trial for autosomal dominant hypocalcemia type 1 (ADH1), encaleret met all primary and secondary endpoints — 76% of patients achieved target serum and urine calcium at 24 weeks versus 4% on standard care, 91% reached intact PTH, and the drug was well tolerated. Separately, the Phase 3 FORTIFY interim readout for BBP‑418 in limb‑girdle muscular dystrophy type 2I/R9 met all primary and secondary endpoints, including a 1.8× increase in glycosylated α‑dystroglycan at three months, an ~82% reduction in serum creatine kinase at 12 months, an ~0.27 m/s improvement in 100‑meter walking speed versus placebo, and roughly a 5% forced vital capacity benefit. Both agents showed favorable safety profiles consistent with prior studies. BridgeBio said it will engage regulators and aims to submit marketing applications for these candidates in the first half of 2026, and the results — together with recent commercial traction from Attruby — have driven a sharp rally in the company's shares. Analysts said the data bolster BridgeBio's case as a multi‑product biotech, though some observers cautioned execution and concentration risks remain.