Neurocrine Biosciences Soars After FDA Approval for CAH Drug

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Neurocrine Biosciences Soars After FDA Approval for CAH Drug

Neurocrine Biosciences, Inc. (NASDAQ:NBIX) shares rose by 5.7% following the approval of CRENESSITY, a new treatment for congenital adrenal hyperplasia (CAH) by the U.S. Food and Drug Administration (FDA). CRENESSITY is the first drug designed to directly target and reduce excessive adrenocorticotropic hormone (ACTH) and adrenal androgen production in patients with this genetic disorder.

The FDA's approval of CRENESSITY, available in both capsule and oral solution forms, marks a significant advancement for those affected by classic CAH, a rare and lifelong condition affecting the adrenal glands. The announcement was made on Friday, and the drug is expected to be commercially available through a specialized pharmacy service, PANTHERx Rare, within a week.

Kyle W. Gano, Ph.D., CEO of Neurocrine Biosciences, emphasized the company's long-standing commitment to CAH research and expressed gratitude to the participants in clinical trials and researchers for their roles in bringing this new class of medication to the CAH community. CARES Foundation Executive Director Dina Matos acknowledged the drug's potential to improve the quality of life for CAH patients by reducing the need for high-dose steroid treatments.

Despite the positive reception of the FDA approval, analysts anticipate a gradual commercial launch. Evan David Seigerman from BMO Capital indicated that broad commercial access is not expected until the second half of 2025, citing various challenges, including a black box warning requiring careful oversight of glucocorticoid treatment adjustments.

Chris Shibutani from Goldman Sachs described the approval as a positive milestone for Neurocrine Biosciences, reaffirming the company's position among biotechnology firms successful in developing multiple drugs across different therapeutic areas. The analyst noted that measuring the initial launch trajectory may be challenging but stated that the company’s progress would be observed in the context of patient acquisition, access, and expansion of insurance coverage.