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.
For more comprehensive insights and updates, visit Neurocrine Biosciences and follow them on LinkedIn, X (formerly Twitter), and Facebook.
On September 19, 2022, Neurocrine Biosciences (Nasdaq: NBIX) shared data at the Psych Congress 2022, showcasing the long-term efficacy of INGREZZA (valbenazine) in treating tardive dyskinesia (TD). The post hoc analysis from the KINECT 4 study revealed that patients' response rates to treatment increased significantly over 48 weeks. Specifically, AIMS improvement rates rose from 39% at week 8 to 86% at week 48. Adverse events were mainly urinary tract infections (8.5%) and headaches (5.2%). This data underscores INGREZZA's lasting benefits for patients suffering from TD.
Neurocrine Biosciences (NASDAQ: NBIX) announced survey findings highlighting the need for enhanced education on managing tardive dyskinesia (TD) symptoms. The data, presented at the MDS International Congress from September 15-18, 2022, in Madrid, revealed that the prevalence of TD is often underestimated. Key findings include an increase in clinicians opting for pharmacologic therapies and acknowledging patient complaints regarding social anxiety. The company emphasizes the importance of managing TD while addressing underlying psychiatric disorders.
On September 15, 2022, Neurocrine Biosciences presented data on ONGENTYS® (opicapone) at the MDS International Congress in Madrid, Spain. The findings indicate that a once-daily 50 mg dose of ONGENTYS alongside levodopa/carbidopa can reduce soluble-catechol-O-methyltransferase (S-COMT) activity by over 80%, leading to more consistent levodopa exposure in Parkinson’s disease patients. The analysis was based on two previous Phase 1 studies, showcasing significant reductions in S-COMT variability. Survey results on clinician education needs in managing Parkinson’s OFF episodes were also discussed.
Neurocrine Biosciences (Nasdaq: NBIX) will present at the Morgan Stanley 20th Annual Global Healthcare Conference on September 13, 2022, at 10:35 a.m. Eastern Time in New York. CEO Kevin Gorman and CFO Matt Abernethy will lead the presentation. The event will be webcast live, accessible via the company's website, with a replay available one hour post-event and archived for a month. Neurocrine is committed to developing treatments for complex neurological, neuroendocrine, and neuropsychiatric disorders, boasting several FDA-approved therapies.
Neurocrine Biosciences reported second quarter net product sales of $350 million for INGREZZA, a 32% increase year-over-year. The company raised 2022 net sales guidance to $1.35 - $1.40 billion due to strong performance driven by better diagnosis of tardive dyskinesia. However, the essential tremor study missed its endpoints, prompting a halt in further development for that indication. The company reported a GAAP net loss of $16.9 million for the quarter. Despite this, non-GAAP earnings were robust, at $82 million for the quarter. Total cash and equivalents stand at approximately $1.1 billion.
Neurocrine Biosciences (Nasdaq: NBIX) will release its Q2 2022 financial results on August 4, 2022, post-market close. A conference call and webcast are scheduled for 1:30 PM Pacific Time the same day, where executives will discuss the results and provide company updates. Participants can join the call at 800-895-3361 (US) or 785-424-1062 (International), using conference ID: NBIX. The event will be available for replay approximately one hour after conclusion, archived for one month on the company's website.
Neurocrine Biosciences has reported significant findings from a Phase 2 study of crinecerfont in adolescents with classic congenital adrenal hyperplasia (CAH). The study, presented at ENDO 2022, showed substantial reductions (up to 76.2%) in key hormones after 14 days of treatment. This investigational, non-steroidal treatment aims to manage CAH without the side effects of glucocorticoids. Two Phase 3 studies are ongoing for both pediatric and adult patients. The treatment was well tolerated with no serious adverse events. This advancement may address a critical unmet need in CAH management.
Neurocrine Biosciences (Nasdaq: NBIX) will present at the Goldman Sachs 43rd Annual Global Healthcare Conference on June 15, 2022, at 10:40 a.m. Pacific Time in Rancho Palos Verdes, CA. CEO Kevin Gorman and CFO Matt Abernethy will represent the company. The live presentation will be webcast on the company's website, with a replay available one hour after the event and archived for one month. Neurocrine focuses on developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders, including FDA-approved treatments for conditions like tardive dyskinesia and Parkinson's disease.
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