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 (NBIX) reported strong financial results for Q4 and fiscal year 2021, with total revenues of $1.133 billion, up from $1.046 billion in 2020. The company achieved net product sales of $1.1 billion for INGREZZA, reflecting 25% growth in Q4 year-over-year. Despite a GAAP net loss of $7 million in Q4, its non-GAAP net income was $4.3 million. For 2022, NBIX guided INGREZZA sales between $1.25 billion and $1.35 billion, indicating approximately 20% growth. The firm is advancing a diverse pipeline with 12 mid-to-late-stage clinical programs.
Neurocrine Biosciences (Nasdaq: NBIX) announced a conference call to discuss its 2021 fourth quarter and year-end financial results on February 11, 2022, at 5:00 a.m. PT (8:00 a.m. ET). The press release will precede this at 4:30 a.m. PT. Investors can access the call via domestic (800-895-3361) and international (785-424-1062) dial-in numbers, using Conference ID: NBIX. A replay will be available on Neurocrine's website following the event, highlighting the company's commitment to addressing neurological and psychiatric disorders through its diverse portfolio and ongoing clinical programs.
Neurocrine Biosciences (NBIX) reported preliminary net product sales of INGREZZA (valbenazine) for Q4 2021, totaling approximately $301 million, showing a 25% increase year-over-year. Total prescriptions rose by 32%. The company is on track to complete its commercial expansion by Q1 2022 and will provide full-year 2022 sales guidance on February 11, 2022. CEO Kevin Gorman highlighted the company's dedication to advancing a broad pipeline with 13 clinical programs expected to yield significant data in the next two years.
Neurocrine Biosciences (Nasdaq: NBIX) will present at the 40th Annual J.P. Morgan Healthcare Conference on Jan. 10, 2022, at 11:15 a.m. Eastern Time. CEO Kevin Gorman will lead the presentation. Investors can watch the live presentation via the company’s website, with a replay available about one hour post-event, archived for one month. Neurocrine focuses on developing treatments for neurological, endocrine, and psychiatric disorders, with an FDA-approved portfolio addressing conditions like tardive dyskinesia and Parkinson's disease.
Neurocrine Biosciences (Nasdaq: NBIX) announced positive top-line results from its Phase 3 KINECT-HD study for valbenazine, targeting chorea in Huntington disease. The study achieved its primary endpoint, showing a placebo-adjusted mean reduction of 3.2 units in the Total Maximal Chorea (TMC) score (p < 0.0001). Secondary endpoints were also significant. No new safety concerns were reported, and no suicidal ideation emerged. The company plans to submit a supplemental new drug application to the FDA in 2022. Chorea affects about 30,000 adults in the U.S.
Neurocrine Biosciences (NASDAQ: NBIX) has appointed Jude Onyia, Ph.D., as the new Chief Scientific Officer. Dr. Onyia brings over 25 years of pharmaceutical industry experience, having served at Capsida Biotherapeutics and Eli Lilly & Co. where he contributed to over 60 clinical candidates leading to seven approved medicines. His leadership is expected to enhance Neurocrine's drug discovery efforts, focusing on developing treatments for neurological and endocrine disorders. CEO Kevin Gorman expressed confidence in Dr. Onyia's vision to advance the company's mission of alleviating patient suffering.
Neurocrine Biosciences (Nasdaq: NBIX) has entered a strategic collaboration with Sosei Group Corporation to develop muscarinic receptor agonists for treating schizophrenia and other neuropsychiatric disorders. The agreement grants Neurocrine rights to a portfolio of M4, M1, and dual agonists, including the advanced program HTL-0016878, a selective M4 agonist. Neurocrine plans to submit an IND application and initiate Phase 2 studies in 2022. Sosei will receive a $100 million upfront payment and up to $2.6 billion in milestone payments, plus royalties on future sales.
Neurocrine Biosciences (Nasdaq: NBIX) announced participation in two key investor conferences. CEO Kevin Gorman and CFO Matt Abernethy will present at the Jefferies London Healthcare Conference on Nov. 16, 2021, at 1:00 p.m. GMT (8:00 a.m. ET). Additionally, CFO Abernethy and CMO Eiry Roberts will participate in the Evercore ISI 4th Annual HealthCONx Virtual Conference on Nov. 30, 2021, at 10:55 a.m. ET. Presentations will be webcast on the company’s website, with replays available for one month after each event.
Neurocrine Biosciences (Nasdaq: NBIX) reported strong Q3 2021 financial results, with total revenues of $296 million, a 14.5% increase from $258.5 million in Q3 2020. Net product sales of INGREZZA reached $287 million, reflecting heightened demand and successful commercial activities. GAAP net income stood at $22.5 million, or $0.23 per share, contrasting sharply with a net loss of $57.6 million in the prior year. R&D expenses increased due to investments in pipeline projects, while total cash reserves were approximately $1.3 billion. The company anticipates further clinical data releases within the next two years.
Neurocrine Biosciences (NASDAQ: NBIX) presented new data on INGREZZA (valbenazine) for treating tardive dyskinesia at the 2021 Psych Congress. Key findings include a pooled analysis showing significant improvement in elderly patients with tardive dyskinesia, development of the MIND-TD questionnaire for better patient-provider communication, and real-world insights on telehealth's impact during the COVID-19 pandemic. The data supports INGREZZA's efficacy and highlights the company's commitment to addressing tardive dyskinesia, which affects approximately 600,000 individuals in the U.S.
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