08:22 AM EDT, 07/01/2024 (MT Newswires) -- Neurocrine Biosciences ( NBIX ) said Monday that the US Food and Drug Administration has accepted two New Drug Applications with Priority review designations for for crinecerfont, to treat children, adolescents, and adults with classic congenital adrenal hyperplasia.
The company said the submitted applications for crinecerfont include a capsule formulation and an oral solution formulation, respectively.
The regulator has set the Prescription Drug User Fee target action dates of Dec. 29 and Dec. 30, respectively, and stated it is not currently planning to hold an advisory committee meeting to discuss these applications, the company said.