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 neuroscience-focused biopharmaceutical company whose news flow centers on clinical data, product performance and pipeline progress in movement disorders, neuropsychiatry, endocrinology and metabolic disease. The company regularly issues updates on its flagship VMAT2 inhibitor INGREZZA (valbenazine) for tardive dyskinesia and chorea associated with Huntington’s disease, including head-to-head pharmacologic studies, long-term efficacy analyses and peer-reviewed publications.
NBIX news commonly features clinical trial readouts across its pipeline. Recent releases have covered Phase 3 and Phase 4 data for INGREZZA in tardive dyskinesia and Huntington’s disease chorea, a Phase 3 study of valbenazine in dyskinetic cerebral palsy, and Phase 2 results for investigational compounds such as NBI-1070770 in major depressive disorder. Investors and clinicians can also follow updates on late-stage programs including osavampator for major depressive disorder and direclidine for schizophrenia and bipolar mania, as well as next-generation VMAT2 inhibitors and CRF-based therapies for metabolic diseases like obesity.
Another major theme in Neurocrine Biosciences news is financial and corporate reporting. The company announces quarterly net product sales for INGREZZA and CRENESSITY, provides guidance ranges for research and development and selling, general and administrative expenses, and discusses its R&D strategy at events such as its annual R&D Day and healthcare investor conferences. Management presentations at large industry meetings, including the J.P. Morgan Healthcare Conference and other investor conferences, are also highlighted in press releases.
This NBIX news page aggregates these updates so readers can quickly review earnings announcements, clinical milestones, R&D strategy briefings, investor conference appearances and key scientific publications related to Neurocrine Biosciences. For anyone tracking developments in tardive dyskinesia, Huntington’s disease chorea, classic congenital adrenal hyperplasia, neuropsychiatric disorders or emerging CRF-based metabolic therapies, the news stream provides a concise view of the company’s ongoing activities and disclosures.
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.
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.