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.
Neurocrine Biosciences (NASDAQ: NBIX) reported significant additional results from the Phase 3 KINECT-HD study on valbenazine for treating chorea associated with Huntington Disease. The study met its primary endpoint with a marked improvement in chorea severity, evidenced by a 3.2 unit reduction in the TMC score (p<0.0001) compared to placebo. Secondary endpoints also favored valbenazine significantly. Treatment-emergent adverse events were mild to moderate, aligning with known safety profiles. The findings were presented at the Huntington Study Group meeting in Tampa, Florida.
Neurocrine Biosciences reported third-quarter 2022 net product sales of $376 million for INGREZZA, a 31% year-over-year increase.
The company raised its 2022 guidance for INGREZZA net sales to between $1.4 billion and $1.425 billion.
An sNDA for valbenazine to treat chorea in Huntington Disease was submitted to the FDA, expanding its therapeutic reach.
GAAP net income rose to $68.5 million or $0.69 per diluted share, reflecting strong performance driven by an expanding patient base and recent sales force enhancements.
Neurocrine Biosciences (Nasdaq: NBIX) has initiated a Phase 2 clinical study for NBI-1117568, a first-in-class muscarinic M4 selective agonist targeting adults with schizophrenia. The study will enroll about 200 patients across 15 U.S. sites, assessing efficacy and safety using the Positive and Negative Syndrome Scale (PANSS). NBI-1117568 aims to provide an improved safety profile and potentially different side effects compared to traditional antipsychotics, addressing a condition that affects approximately 20 million people worldwide.
Neurocrine Biosciences (NASDAQ: NBIX) presented the baseline characteristics of Parkinson's disease patients in the Opicapone Treatment Initiation Open-Label Study (OPTI-ON) at ANA2022. The study included 239 participants across 30 U.S. sites, focusing on the use of ONGENTYS as an adjunct treatment to carbidopa/levodopa. The mean age of participants was 67.7 years with a mean Parkinson's duration of 8.6 years. Findings will assess treatment patterns and safety, complementing data from pivotal trials. ONGENTYS, approved in April 2020, helps increase levodopa availability for better treatment outcomes.
On October 19, 2022, Neurocrine Biosciences (Nasdaq: NBIX) presented a retrospective study on the use of benztropine among patients prescribed antipsychotic medications at the 2022 APNA Annual Conference. The study analyzed data from January 2017 to March 2020, revealing significant polypharmacy in patients prescribed benztropine. Key findings indicated that 38% of patients used benztropine for over six months, suggesting a need for better management of anticholinergic medications. The Chief Medical Officer emphasized that while benztropine aids in acute treatment, it is not suitable for tardive dyskinesia.
Neurocrine Biosciences (Nasdaq: NBIX) will host its third quarter 2022 financial results conference call and webcast on November 1, 2022, at 5:00 a.m. PT (8:00 a.m. ET). The Q3 press release will be available earlier on the same day at 4:30 a.m. PT (7:30 a.m. ET). Investors can access the call via domestic 866-952-8559 or international 785-424-1881 dial-in numbers using conference ID NBIX. A replay will be available on the company’s website.
Neurocrine focuses on treatments for neurological and psychiatric disorders.
Neurocrine Biosciences (NASDAQ: NBIX) announced the appointment of Dr. Ingrid Delaet as its Chief Regulatory Officer, effective October 1, 2022. Dr. Delaet, previously the Vice President of Regulatory Affairs at Neurocrine since January 2021, will oversee regulatory affairs, quality assurance, medical writing, and program management. Her extensive background includes senior roles at Intercept Pharmaceuticals and Bristol-Myers Squibb. CEO Kevin Gorman noted her experience will significantly contribute to the company's goal of developing innovative treatments for neurological and neuropsychiatric disorders.
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.
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