Neurocrine Biosciences rises on FDA nod for CAH drug

Shares of Neurocrine (NASDAQ:NBIX ) Biosciences, Inc. (NASDAQ:NBIX) climbed 5.7% following the U.S. Food and Drug Administration’s approval of CRENESSITY, a new treatment for congenital adrenal hyperplasia (CAH). CRENESSITY is the first medication to directly target and reduce excess adrenocorticotropic hormone (ACTH) and adrenal androgen production in patients with this genetic disorder.

The FDA's green light for CRENESSITY, which is both a capsule and oral solution, marks a significant advancement for those affected by classic CAH, a rare and lifelong condition that impacts the adrenal glands. The approval was announced Friday, and the medication is slated to become commercially available within a week through PANTHERx Rare, a specialized pharmacy service.

Kyle W. Gano, Ph.D., CEO of Neurocrine Biosciences, highlighted the company's long-standing commitment to CAH research and expressed gratitude to the clinical trial participants and investigators for their roles in bringing this new class of medicine to the CAH community. Dina Matos, Executive Director of the CARES Foundation, also 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 of BMO Capital pointed out several challenges, including broad commercial access not expected until the second half of 2025 and the drug's black box warning requiring careful supervision of glucocorticoid therapy adjustments.

Chris Shibutani of Goldman Sachs noted the approval as a positive milestone for Neurocrine Biosciences, confirming its status among biotech firms successful in developing multiple drugs across different therapeutic areas. The analyst mentioned that while the initial launch trajectory may be difficult to quantify, the company's progress will be monitored in the context of patient capture and expansion of access and insurance coverage.

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Source: Investing.com