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.
Overview
Neurocrine Biosciences Inc is a neuroscience-focused, product-based biopharmaceutical company dedicated to discovering, developing, and commercializing innovative treatments that address significant unmet medical needs. Combining deep expertise in neurology, endocrinology, and neuropsychiatry, the company has established itself in creating therapies for conditions ranging from tardive dyskinesia and Huntington's disease chorea to endocrine disorders like congenital adrenal hyperplasia and conditions related to reproductive health. Through robust research and strategic development, Neurocrine Biosciences leverages state-of-the-art scientific approaches and clinical insights to provide treatments that target complex pathologies with precision.
Core Competencies and Therapeutic Focus
Neurocrine Biosciences stands at the nexus of innovative drug discovery and clinical excellence. Its core therapeutic areas revolve around:
- Neurological Disorders: Developing treatments that target abnormal involuntary movements and other neurological conditions by modulating key neurotransmitter systems.
- Neuroendocrine and Endocrine Disorders: Researching and launching products addressing hormonal imbalances and disorders such as congenital adrenal hyperplasia and endometriosis, where traditional therapies have long been challenged.
- Neuropsychiatric Conditions: Investigating the interconnections between brain and body to develop therapies that alleviate symptoms associated with cognitive impairment, mood disorders, and related conditions.
Product Portfolio and Pipeline
With a diversified portfolio, Neurocrine Biosciences has successfully brought several therapeutics to market while continuously advancing a pipeline of innovative drug candidates. Its flagship products focus on alleviating severe movement disorders; for example, its products for tardive dyskinesia and chorea associated with Huntington's disease utilize mechanisms that adjust dopamine signaling via selective inhibition of vesicular monoamine transporters. Additionally, the company has pioneered new therapeutic approaches for conditions historically managed with high-dose steroids, offering promising alternatives that target the underlying neuroendocrine pathways. This balanced product and pipeline strategy exemplifies its commitment to addressing very specific niches within the broader pharmaceutical market.
Research, Development, and Scientific Rigor
Emphasizing advanced research methodologies, Neurocrine Biosciences consistently applies its unique scientific insights to unravel the complexities of brain and body interactions. The company’s research and development efforts are grounded in clinical evidence and rigorous scientific validation, ensuring that each therapy is backed by robust data from well-designed studies. This dedication to scientific rigor not only enhances the credibility of its products but also ensures adherence to the highest safety and efficacy standards, a cornerstone of its operational ethos.
Market Position and Competitive Edge
Operating in a highly specialized niche within the biopharmaceutical sector, Neurocrine Biosciences differentiates itself with a deep commitment to patient-centric innovation and complex disease understanding. The company’s extensive experience over several decades, combined with its targeted research, underscores its authority in neurotherapeutics. Rather than taking a broad-market approach, it focuses on disease areas with significant unmet needs, building a competitive edge through tailored therapeutic solutions and a strong commitment to clinical excellence.
Conclusion
In summary, Neurocrine Biosciences Inc is a prime example of a modern, scientifically driven biopharmaceutical company that employs its deep understanding of neuroscience and endocrinology to develop treatments for conditions that have long challenged conventional medical approaches. Its blend of clinical innovation, rigorous research, and targeted treatment strategies positions it as a trusted name in addressing some of the most complex neurologically and endocrinologically related diseases. For investors and medical professionals alike, the company represents an enduring commitment to relieving suffering through brave science and thoughtful, evidence-based solutions.
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.
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.