Neurocrine Biosciences Gets FDA Breakthrough Therapy Status for Genetic Disorder Treatment
By Ben Glickman
Neurocrine Biosciences has received breakthrough therapy designation for its treatment for congenital adrenal hyperplasia from the U.S. Food and Drug Administration.
The San Diego-based biotechnology company said Tuesday it was on track to submit a new drug application for crinecerfont in the treatment of congenital adrenal hyperplasia, a genetic disorder, in 2024.
The company announced it was on track to advance two gene therapies into the clinic in 2025, and expects to have more than 20 development candidates by 2027.
Chief Medical Officer Eiry Roberts said the FDA designation for crinecerfont was an acknowledgement of the seriousness of congenital adrenal hyperplasia and the unmet need faced by patients.
Breakthrough therapy designation is given by the FDA to speed up development of treatments for serious conditions that show preliminary evidence of effectiveness.
Write to Ben Glickman at ben.glickman@wsj.com
(END) Dow Jones Newswires
December 05, 2023 16:38 ET (21:38 GMT)
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