BridgeBio clears key FDA milestone for rare calcium disorder therapy encaleret

BridgeBio Pharma (Nasdaq: BBIO) has moved closer to bringing a first targeted treatment for autosomal dominant hypocalcemia type 1 (ADH1) to market after the US Food and Drug Administration (FDA) accepted its New Drug Application for encaleret.

The agency has set a Prescription Drug User Fee Act (PDUFA) target action date of May 8, 2027, and is not currently planning to hold an advisory committee meeting, the company said. If approved, encaleret could become the first therapy specifically indicated for ADH1, a rare genetic disorder caused by overactivity of the calcium-sensing receptor (CaSR).