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 (NBIX) is a leading neuroscience-focused biopharmaceutical company developing innovative therapies for complex neurological, endocrine, and neuropsychiatric disorders. This comprehensive news hub provides investors and healthcare professionals with timely updates on clinical developments, regulatory milestones, and strategic initiatives driving the company's mission to address unmet medical needs.
Stay informed with verified updates spanning FDA decisions, clinical trial results, research collaborations, and market expansion efforts. Our curated news collection covers essential developments including movement disorder therapies like Ingrezza® for tardive dyskinesia, endocrine disorder treatments, and emerging pipeline candidates in neuropsychiatry.
Key focus areas include updates on late-stage clinical programs, partnership announcements with academic institutions, and analyses of therapeutic innovations targeting conditions from Huntington's disease chorea to congenital adrenal hyperplasia. All content is rigorously sourced to ensure accuracy and relevance for both professional investors and medical stakeholders.
Bookmark this page for centralized access to Neurocrine Biosciences' latest scientific advancements, financial disclosures, and treatment development progress. Check regularly for objective reporting on one of biopharma's most innovative neuroscience-focused enterprises.
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.
On October 19, 2022, Neurocrine Biosciences (Nasdaq: NBIX) presented a retrospective study on the use of benztropine among patients prescribed antipsychotic medications at the 2022 APNA Annual Conference. The study analyzed data from January 2017 to March 2020, revealing significant polypharmacy in patients prescribed benztropine. Key findings indicated that 38% of patients used benztropine for over six months, suggesting a need for better management of anticholinergic medications. The Chief Medical Officer emphasized that while benztropine aids in acute treatment, it is not suitable for tardive dyskinesia.
Neurocrine Biosciences (Nasdaq: NBIX) will host its third quarter 2022 financial results conference call and webcast on November 1, 2022, at 5:00 a.m. PT (8:00 a.m. ET). The Q3 press release will be available earlier on the same day at 4:30 a.m. PT (7:30 a.m. ET). Investors can access the call via domestic 866-952-8559 or international 785-424-1881 dial-in numbers using conference ID NBIX. A replay will be available on the company’s website.
Neurocrine focuses on treatments for neurological and psychiatric disorders.
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