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 March 3, 2023, Neurocrine Biosciences (NASDAQ: NBIX) presented data at the AAGP 2023 Annual Meeting in New Orleans, focusing on the long-term treatment of tardive dyskinesia (TD) in older and elderly patients using INGREZZA (valbenazine). The findings showed that over 80% of patients aged 65+ achieved a clinically meaningful reduction in TD symptoms after 48 weeks of treatment. The study highlighted significant improvements in AIMS total scores and psychiatric stability across both age groups. The results are expected to inform treatment decisions for older adults at risk of TD.
On February 14, 2023, at 12:00 p.m. Eastern Time, Neurocrine Biosciences (NASDAQ: NBIX) will present at the virtual SVB Securities Global Biopharma Conference. The presentation will be led by CEO Kevin Gorman and CFO Matt Abernethy. Interested parties can access the live webcast on the company’s website under the Investors section. A replay will be available approximately one hour post-event and archived for one month. Neurocrine Biosciences focuses on developing treatments for under-addressed neurological, neuroendocrine, and neuropsychiatric disorders, with a diverse portfolio and 12 mid-to-late-stage clinical programs.
Neurocrine Biosciences reported fourth quarter net product sales of $399 million for INGREZZA, contributing to full-year sales of $1.44 billion. The company projects net product sales guidance for 2023 between $1.67 - $1.77 billion. Key developments include the completion of enrollment in registrational studies for crinecerfont, aimed at treating congenital adrenal hyperplasia, with top-line results expected in the second half of 2023. Financial highlights show a GAAP net income of $89 million for Q4 2022, a significant improvement over the $7 million loss in Q4 2021. Total cash and marketable securities stood at $1.29 billion as of December 31, 2022.
Neurocrine Biosciences (Nasdaq: NBIX) has scheduled its fourth quarter and year-end 2022 financial results conference call and webcast for February 6, 2023. The press release will be issued at 4:30 a.m. PT and the call will begin at 5:00 a.m. PT (8:00 a.m. ET). The conference call can be accessed domestically at 866-952-8559 and internationally at 785-424-1743, using conference ID NBIX. A replay will be available approximately an hour after the event and archived for a month. Neurocrine focuses on developing treatments for neurological and endocrine disorders, with several FDA-approved therapies in its portfolio.
Neurocrine Biosciences (Nasdaq: NBIX) will present at the 41st Annual J.P. Morgan Healthcare Conference on January 9, 2023, at 11:15 a.m. PT in San Francisco. CEO Kevin Gorman will lead the presentation, which can be accessed via a live webcast on the company's website, www.neurocrine.com. A replay will be available approximately one hour post-event and archived for a month. Neurocrine focuses on developing treatments for neurological and neuroendocrine disorders, with FDA-approved therapies for tardive dyskinesia, Parkinson's disease, endometriosis, and uterine fibroids in its portfolio.
Neurocrine Biosciences (Nasdaq: NBIX) has announced that the FDA has accepted its supplemental New Drug Application for valbenazine, targeting chorea associated with Huntington disease, with a PDUFA action date set for August 20, 2023. This sNDA includes data from the KINECT-HD Phase 3 study and ongoing KINECT-HD2 study, involving over 150 patients. Valbenazine aims to provide a new treatment option for the estimated 40,000 adults in the U.S. affected by Huntington disease, characterized by abnormal involuntary movements.
Neurocrine Biosciences (Nasdaq: NBIX) announced that its investigational drug NBI-827104 did not achieve its primary endpoint in the Phase 2 STEAMBOAT study for treating pediatric patients with epileptic encephalopathy characterized by continuous spike-and-wave during sleep. The study aimed to measure the drug's efficacy against placebo in reducing the spike-wave index after 6 weeks. Despite the setback, the drug was well tolerated, and the company plans to analyze the data for future steps in development.
Neurocrine Biosciences (NBIX) reported data from a genetic screening study involving over 17,000 children with SCN8A-related epilepsies, highlighting the phenotypic spectrum and seizure burden experienced. The findings were shared at the AES 2022 Annual Meeting in Nashville. The study revealed that 0.2% of patients had pathogenic SCN8A variants, with a mean seizure onset age of 1.4 years. Neurocrine is conducting a Phase 2 clinical trial for NBI-921352, aimed at treating SCN8A developmental and epileptic encephalopathy. The company has received FDA designations for this investigational therapy.
On November 8, 2022, Neurocrine Biosciences (Nasdaq: NBIX) announced participation in two investor conferences. The management team, including CEO Kevin Gorman, CFO Matt Abernethy, and Kyle Gano, will present at the Jefferies London Healthcare Conference on November 15 at 1:30 PM GMT. Additionally, Gorman and Abernethy will speak at the 5th Annual Evercore HealthCONx Virtual Conference on December 1 at 12:35 PM ET. Both events will be webcasted and are accessible on the company's website.
On November 3, 2022, Neurocrine Biosciences (Nasdaq: NBIX) presented findings at the ASCP 2022 Annual Meeting regarding the in vitro dissolution performance of INGREZZA (valbenazine) capsules. The study revealed that crushing the capsule contents, irrespective of the strength (40 mg or 80 mg), did not affect dissolution performance, showcasing rapid drug release. This data supports the medication's accessibility for patients with tardive dyskinesia who face difficulties swallowing capsules. Additionally, the company will share long-term data on valbenazine's effectiveness in elderly patients.
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