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 (NBIX) has initiated a Phase 3 registrational study for osavampator, a potential first-in-class adjunctive treatment for major depressive disorder (MDD). This announcement follows positive topline data from the Phase 2 SAVITRI™ study reported in April 2024, where the drug met its primary and secondary endpoints and showed good tolerability.
The drug aims to address a significant unmet need, as MDD affects over 21 million people in the United States, with more than one-third of patients experiencing debilitating symptoms that current treatments cannot fully address. The Phase 3 study will evaluate the drug's efficacy, safety, and tolerability as an adjunctive therapy to antidepressants.
Neurocrine Biosciences (NBIX) has amended its collaboration agreement with Takeda regarding osavampator, a potential first-in-class AMPA positive allosteric modulator for major depressive disorder (MDD). Under the new terms, Neurocrine gains exclusive worldwide development and commercialization rights for all indications, except in Japan, which Takeda will control.
The restructured agreement establishes that each company will be responsible for development costs in their respective regions and both parties will be eligible for royalty payments. Following a successful End-of-Phase 2 meeting with the FDA, Neurocrine plans to initiate the Phase 3 program for osavampator in the first half of this year.
Neurocrine Biosciences (NBIX) has appointed Andrew Ratz, Ph.D. as Senior Vice President of Drug Development, Delivery and Device. Dr. Ratz will lead the transformation of Neurocrine's Chemistry, Manufacturing and Controls organization to support the company's expanding R&D portfolio.
Dr. Ratz joins Neurocrine following a 28-year tenure at Eli Lilly, where he contributed to developing and registering over 25 products across multiple therapeutic areas. His most recent role was Senior Vice President and Head of Drug Delivery, Device and Connected Solutions, where he led the integrated design of devices, drug-device combination products, and packaging systems. He previously served as Senior Director of Process Chemistry and Chemical Engineering and Head of Global Outsourcing for Lilly's small molecule portfolio.
Neurocrine Biosciences (NBIX) announced the publication of a supplement focused on classic congenital adrenal hyperplasia (CAH) in The Journal of Clinical Endocrinology & Metabolism. The supplement, comprising eight review articles, provides comprehensive insights into the challenges and management of classic CAH due to 21-hydroxylase deficiency.
The publication features contributions from leading endocrinologists and researchers, covering topics such as pathophysiology, clinical manifestations, treatment challenges, and advances in treatment, including CRENESSITY™ (crinecerfont), the first oral treatment that directly reduces excess adrenocorticotropic hormone and adrenal androgen production.
The supplement aims to enhance healthcare professionals' understanding of CAH management and improve patient care through evidence-based approaches. It addresses various aspects including genetics, treatment challenges in different age groups, mental health issues, and barriers to management.
Neurocrine Biosciences (NBIX) announced the publication of a narrative review discussing challenges in treating classic congenital adrenal hyperplasia (CAH) with traditional glucocorticoids (GCs) and potential benefits of new non-GC treatments. The review, published in Expert Review of Endocrinology & Metabolism, highlights how non-GC mechanisms could enable lower, more physiologic GC dosing while managing excess ACTH and androgens.
The publication emphasizes that chronic exposure to high-dose GC treatment can lead to severe cardiovascular, metabolic, and skeletal complications, affecting patients' mental health and quality of life. The FDA recently approved CRENESSITY™ (crinecerfont), the first and only classic CAH treatment that directly reduces excess ACTH and adrenal androgen production, allowing for GC dose reduction in patients four years and older.
Neurocrine Biosciences (NBIX) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. The presentation is scheduled for Monday, January 13, 2025, at 8:15 a.m. Pacific Time.
Chief Executive Officer Kyle Gano will deliver the company's presentation, which will be accessible through a live webcast on the company's website under the Investors section at www.neurocrine.com. For those unable to attend the live event, a replay will be made available approximately one hour after the presentation concludes and will remain accessible for about one month.
Neurocrine Biosciences (NBIX) announced the commercial availability of CRENESSITY™ (crinecerfont) in the United States. The drug, recently FDA-approved, is a first-in-class treatment for classic Congenital Adrenal Hyperplasia (CAH) in patients aged 4 and older. CRENESSITY is exclusively distributed through PANTHERx Rare pharmacy, with 24/7 CAH-trained pharmacist support.
As an adjunctive treatment to glucocorticoid replacement, CRENESSITY allows patients to take lower doses of glucocorticoids while maintaining or improving androgen levels. The company expects 90% of patients will have a monthly copay of $12 or less, supported by their comprehensive Neurocrine Access Support program.
Neurocrine Biosciences (NBIX) has received FDA approval for CRENESSITY™ (crinecerfont), the first new treatment in 70 years for classic congenital adrenal hyperplasia (CAH). The drug is approved as an adjunctive treatment to glucocorticoid replacement for patients aged 4 and older.
The approval is supported by the largest-ever CAH clinical trial program, with significant results in both pediatric and adult studies. In pediatric trials, CRENESSITY showed 4x greater steroid dose reduction versus placebo. In adult trials, 63% of patients achieved glucocorticoid dose reduction while maintaining or improving androgen levels, compared to 18% on placebo.
The drug will be commercially available within a week through PANTHERx Rare pharmacy, with most patients expected to pay $10 or less monthly.
Neurocrine Biosciences (NBIX) has announced its participation in two major investor conferences this December. The company will present at The 7th Annual Evercore HealthCONx Conference on December 3 at 10:50 a.m. ET in Coral Gables, Florida, and Citi's 2024 Global Healthcare Conference on December 4 at 1:45 p.m. ET in Miami.
The presentations will be accessible via webcast on Neurocrine's website, with replays available for approximately one month. The company, focused on neuroscience and biopharmaceuticals, develops treatments for neurological, neuroendocrine, and neuropsychiatric disorders, with FDA-approved treatments for conditions including tardive dyskinesia, Huntington's disease chorea, endometriosis, and uterine fibroids.
Neurocrine Biosciences (NBIX) presented new KINECT-HD study data showing INGREZZA (valbenazine) demonstrated consistent efficacy in reducing chorea across 19 subgroups of Huntington's disease patients. The analysis revealed significant improvements compared to placebo, with a least-squares mean difference of -3.2 in chorea reduction. The study also showed improvements in emotional health aspects, including reduced anger (-1.7 vs -0.2 placebo), feeling overwhelmed (-1.7 vs -0.4), and anxiety (-1.4 vs -0.5). Safety assessments indicated no worsening in anxiety symptoms, depression, or suicidal ideation with INGREZZA treatment.