BridgeBio Pharma (BBIO) said Tuesday that it has submitted a new drug application to the US Food and Drug Administration for encaleret, a potential treatment for autosomal dominant hypocalcemia type 1 (ADH1), a rare genetic condition affecting calcium levels.

The filing is backed by results from a phase 3 trial, where the drug met all main and key secondary goals, the company said.

The study showed 76% of patients on encaleret achieved target serum and urine calcium levels, compared with just 4.4% on standard treatment, it said.

If approved, encaleret could be the first approved therapy specifically indicated for individuals living with ADH1, the company said.

BridgeBio said it is targeting a US launch in early 2027 and plans to file for approval in Europe later this year.