Neurocrine Biosciences Gets FDA Breakthrough Therapy Status for Genetic Disorder Treatment
06 December 2023 - 8:53AM
Dow Jones News
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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