SAN DIEGO - Neurocrine (NASDAQ:NBIX) Biosciences, Inc. (NASDAQ:NBIX), a $13.66 billion biopharmaceutical company with an EXCELLENT financial health rating according to InvestingPro, announced today the commercial availability of CRENESSITY™ (crinecerfont) in the United States for patients with classic congenital adrenal hyperplasia (CAH). The oral medication, approved by the U.S. Food and Drug Administration (FDA), is designed to be used alongside glucocorticoids to better control androgen levels in adults and children aged four and above.
CRENESSITY, a first-in-class corticotropin-releasing factor type 1 receptor (CRF1) antagonist, aims to reduce the high doses of glucocorticoids traditionally required by CAH patients, potentially improving their androgen levels. The FDA's approval was supported by the CAHtalyst™ Pediatric and Adult studies, which are the largest clinical trial programs to date for classic CAH.
Kyle W. Gano, Ph.D., CEO of Neurocrine Biosciences, emphasized the company's commitment to supporting patients' access to CRENESSITY through a comprehensive assistance program. This program includes a dedicated Care Coordinator to help navigate insurance processes and financial assistance options, with the expectation that 90% of patients will have a monthly copay of $12 or less.
The medication is exclusively available through PANTHERx Rare, a specialty pharmacy with CAH-trained pharmacists available around the clock for support. CRENESSITY comes in capsule and oral solution form, with dosages tailored to patient age and weight.
The press release notes that CAH is a rare genetic condition affecting adrenal steroid hormone production, with serious potential complications if left untreated. Traditional treatment has involved high doses of glucocorticoids, which can lead to significant side effects.
Neurocrine Biosciences, a neuroscience-focused biopharmaceutical company, has a portfolio of FDA-approved treatments and a pipeline of mid- to late-phase clinical development compounds.
This news is based on a press release statement from Neurocrine Biosciences, Inc.
In other recent news, Neurocrine Biosciences has been gaining attention following the U.S. Food and Drug Administration’s approval of CRENESSITY, a new treatment for congenital adrenal hyperplasia (CAH). The approval of this drug, which is the first medication to directly target and reduce excess adrenocorticotropic hormone (ACTH) and adrenal androgen production, has been seen as a significant advancement for those affected by CAH. Despite this, analysts, including Evan David Seigerman of BMO Capital, anticipate a gradual commercial launch due to various challenges.
In response to these developments, several firms, including Goldman Sachs and H.C. Wainwright, have maintained their Buy ratings on Neurocrine Biosciences. Goldman Sachs also adjusted its price target for the company's shares, increasing it to $182 from $177. In contrast, BMO Capital maintained its Market Perform rating with a steady price target of $121.00, citing initial hurdles for the drug's adoption.
Piper Sandler confirmed its Overweight rating on Neurocrine Biosciences with a price target of $160.00, based on a survey of pediatric endocrinologists indicating significant demand for the newly approved drug, especially among pediatric and adolescent patients. These recent developments highlight the company's ongoing commitment to developing effective treatments for neurological and endocrine-related diseases and disorders.
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