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 May 12, 2022, Neurocrine Biosciences announced that the FDA granted Orphan Drug Designation for valbenazine to treat chorea associated with Huntington disease (HD). This follows the Phase 3 KINECT-HD study results, which evaluated valbenazine's efficacy and safety in adults with HD. The company's CEO emphasized its commitment to developing treatments for rare diseases. Currently, the KINECT-HD2 open-label study is ongoing to assess long-term safety of valbenazine. The supplemental new drug application (sNDA) is anticipated later this year, aiming to provide new options for HD patients.
Neurocrine Biosciences (NBIX) reported Q1 2022 net product sales of $303 million for INGREZZA, marking a 32% increase year-over-year. Total revenues reached $310.6 million, up from $236.6 million a year earlier. The company reiterated its full-year sales guidance for INGREZZA between $1.25 - $1.35 billion, anticipating 20% growth. GAAP net income was $13.9 million, down from $32.1 million in Q1 2021. Increased R&D and SG&A expenses were noted, correlating with expanded clinical programs and salesforce efforts.
Neurocrine Biosciences (Nasdaq: NBIX) will present at the Bank of America Securities 2022 Healthcare Conference on May 10, 2022, at 11:20 a.m. PT in Las Vegas. CEO Kevin Gorman and CFO Matt Abernethy will represent the company. The presentation will be available via live webcast on the company's website, with a replay accessible after one hour post-event for about a month. Neurocrine focuses on developing treatments for neurological and neuropsychiatric disorders, with a range of FDA-approved therapies and ongoing clinical programs.
Neurocrine Biosciences (Nasdaq: NBIX) announced its first quarter 2022 financial results conference call and webcast scheduled for May 4, 2022, at 5:00 a.m. PT (8:00 a.m. ET). The Q1 2022 press release will be made available at 4:30 a.m. PT (7:30 a.m. ET) on the same day. Investors can join via a domestic dial-in number (800-895-3361) or international dial-in number (785-424-1062), using the conference ID: NBIX. The webcast link will be accessible on the Neurocrine Biosciences website, with a replay available for one month.
Neurocrine Biosciences announced that valbenazine met its primary endpoint in the Phase 3 KINECT-HD study, showing a significant improvement in chorea severity in Huntington disease patients compared to placebo (p<0.0001). Improvements were evident as early as Week 2. Response rates for clinical and patient global impressions also favored valbenazine. The company plans to submit a supplemental new drug application to the FDA in 2022. The safety profile was consistent with prior studies, with no serious adverse events reported.
Neurocrine Biosciences (Nasdaq: NBIX) announced on March 28, 2022, that its collaboration partner, Mitsubishi Tanabe Pharma Corporation, received regulatory approval from the Japanese Ministry of Health for DYSVAL® (valbenazine) capsules 40 mg, aimed at treating tardive dyskinesia (TD). This approval signifies a key milestone in their partnership established in March 2015, under which MTPC covers all costs related to development and commercialization in Japan and select Asian markets. Neurocrine will earn tiered royalties on future sales, bolstering its financial outlook.
Neurocrine Biosciences (Nasdaq: NBIX) will present new research on treatment patterns and unmet needs for congenital adrenal hyperplasia (CAH) at the AMCP 2022 annual meeting in Chicago from March 29 to April 1. The studies highlight the challenges in managing classic CAH, for which no non-steroidal FDA-approved treatments exist. Current treatment relies on glucocorticoids, posing risks of complications. The company is developing crinecerfont, a non-steroidal CRF1 receptor antagonist, advancing two Phase 3 studies for both adults and children with classic CAH.
Neurocrine Biosciences (Nasdaq: NBIX) announced the presentation of its movement disorders program and telemedicine research at the AAN Annual Meeting from April 2-7, 2022, in Seattle. The research reveals a significant gap in evidence regarding telemedicine's effects on individuals with serious mental illnesses and movement disorders, indicating the need for further studies. The company will also showcase data on INGREZZA (valbenazine) and ONGENTYS (opicapone) in treating tardive dyskinesia and Parkinson's disease, respectively, highlighting ongoing commitments to patient care and treatment outcomes.
Neurocrine Biosciences will present at the Stifel 2022 CNS Days virtual conference on March 28, 2022, at 3:30 p.m. Eastern Time. The presentation will be led by Eiry Roberts, Chief Medical Officer, and Kyle Gano, Chief Business Development and Strategy Officer. Attendees can access the live webcast on the company's website under the Investors section. A replay will be available about one hour post-event and archived for a month. Neurocrine specializes in therapies for neurological and neuroendocrine disorders, with an array of FDA-approved treatments and clinical programs.
Neurocrine Biosciences (Nasdaq: NBIX) announced participation in upcoming investor conferences. CEO Kevin Gorman will present at the Cowen 42nd Annual Virtual Health Care Conference on March 8, 2022, at 9:10 a.m. ET. He and CFO Matt Abernethy will also present at the Barclays Global Healthcare Conference on March 16, 2022, at 3:50 p.m. ET in Miami. Additionally, Kyle Gano will speak at the 1st Annual Needham Virtual Neuroscience Forum on the same day at 1:50 p.m. ET. Webcasts will be available on the company's website.
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