NasdaqGS:BBIOBiotechs
Is FDA’s Encaleret NDA Acceptance Redefining the Investment Case For BridgeBio Pharma (BBIO)?
BridgeBio Pharma recently announced that the FDA has accepted for filing its New Drug Application for encaleret to treat autosomal dominant hypocalcemia type 1, assigning a PDUFA target action date of May 8, 2027, and indicating no advisory committee meeting is currently planned.
If approved, encaleret would be the first therapy specifically indicated for ADH1, targeting the underlying genetic cause and potentially obviating the need for chronic calcium and vitamin D supplementation in this...