Welcome to our dedicated page for Neurocrine Biosciences news (Ticker: NBIX), a resource for investors and traders seeking the latest updates and insights on Neurocrine Biosciences stock.
Neurocrine Biosciences Inc. (Nasdaq: NBIX) is a premier neuroscience-focused biopharmaceutical company based in San Diego. Established in 1992, the company is committed to developing and commercializing innovative pharmaceutical products that address unmet medical needs. Neurocrine Biosciences specializes in treatments for neurological, neuroendocrine, and neuropsychiatric disorders, impacting some of the largest pharmaceutical markets worldwide, including segments dealing with endometriosis, irritable bowel syndrome, anxiety, depression, pain, diabetes, insomnia, and other related conditions.
The company’s extensive portfolio includes FDA-approved treatments such as INGREZZA for tardive dyskinesia and chorea associated with Huntington's disease, along with investigational candidates like elagolix, opicapone, and crinecerfont. Notable late-stage clinical programs are:
- Elagolix: A hormone-releasing antagonist for women's health, particularly in treating endometriosis and uterine fibroids in collaboration with AbbVie.
- Opicapone: A catechol-O-methyltransferase (COMT) inhibitor for Parkinson's disease patients.
- Ingrezza: For treating Tourette syndrome and other movement disorders.
Recently, Neurocrine announced the initiation of a Phase 1 clinical study for NBI-1076986, an investigational M4 subtype-selective muscarinic acetylcholine receptor antagonist aimed at treating movement disorders such as Parkinson's disease tremor and dystonia. This is part of their broader muscarinic receptor-focused portfolio, which includes a variety of small molecule M1, M1/M4, and M4 agonists acquired from Nxera Pharma.
Neurocrine's robust pipeline also includes the CAHtalyst™ studies, which focus on crinecerfont for congenital adrenal hyperplasia (CAH), demonstrating significant potential in reducing glucocorticoid doses while maintaining androgen control. Their recent presentations at the American Association of Clinical Endocrinology 2024 Annual Meeting and the European Congress of Endocrinology 2024 highlight their continuous advancements.
Financially, Neurocrine Biosciences maintains a strong position with a multi-billion-dollar product in INGREZZA, and a diverse pipeline of 17 clinical development programs. Notably, the company announced the retirement of CEO Kevin Gorman, Ph.D., with Kyle Gano, Ph.D., set to succeed him in October 2024, ensuring a seamless transition and continued focus on innovative treatments.
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Neurocrine Biosciences, Inc. (NBIX) supports Tardive Dyskinesia Awareness Week to advocate for routine screening and monitoring of TD, a movement disorder caused by antipsychotic medication affecting approximately 600,000 people in the U.S. annually.
Neurocrine Biosciences presented CAHtalyst™ Pediatric Study Baseline Characteristics and CAHtalog™ Registry Data at PES 2024, highlighting the need for novel treatments in children and adolescents with Congenital Adrenal Hyperplasia (CAH). The data showcased the challenges in long-term CAH management, emphasizing the limitations of current treatment approaches and the difficulties in disease management as patients age into adulthood. Additionally, positive top-line data from previous Phase 3 clinical studies supported two New Drug Applications submitted to the FDA in April 2024.
Neurocrine Biosciences reported first-quarter 2024 financial results, with INGREZZA net product sales of $506 million, representing 23% growth year-over-year. They also announced FDA approval for INGREZZA SPRINKLE capsules and submitted New Drug Applications for crinecerfont. Positive Phase 2 data for NBI-1065845 in major depressive disorder was highlighted, along with strong financial performance and a robust pipeline, positioning the company as a neuroscience leader.
Neurocrine Biosciences, Inc. announced the U.S. FDA approval of INGREZZA SPRINKLE (valbenazine) capsules for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease. This new oral granules formulation provides an alternative administration option for patients with swallowing difficulties. INGREZZA SPRINKLE offers three effective dosages and can be easily sprinkled on soft food for oral administration.
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