Neurocrine Biosciences Inc. reports biopharmaceutical developments across neurological, psychiatric, endocrine and immunological disorders. Recurring updates include commercial and clinical information for INGREZZA for tardive dyskinesia and chorea associated with Huntington's disease, CRENESSITY for classic congenital adrenal hyperplasia, and approved therapies for endometriosis and uterine fibroids.
Company news also covers CAHtalyst clinical data, peer-reviewed publications on glucocorticoid dosing and the Tardive Dyskinesia Impact Scale, pipeline programs such as NBIP-'2118, financial results, healthcare conference participation, and governance or capital-structure matters tied to Neurocrine's public-company reporting.
Neurocrine Biosciences (Nasdaq: NBIX) announced that its Phase 3 KINECT-DCP study of valbenazine in pediatric and adult participants with dyskinetic cerebral palsy did not meet primary or key secondary endpoints (Dec. 22, 2025).
The 14-week, double-blind, placebo-controlled study—described as the largest trial ever completed in DCP—assessed improvement in chorea. Adverse events were reported as generally consistent with valbenazine's established safety profile. The company thanked patients, families, investigators, and site staff and said it will present full study results at an upcoming scientific meeting.
Neurocrine Biosciences (NASDAQ: NBIX) outlined a transformed R&D strategy at its 2025 R&D Day focused on neuroscience and endocrinology, aiming to deliver multiple first‑ and best‑in‑class medicines this decade. Key clinical milestones include topline Phase 3 data for osavampator and direclidine expected in 2027, additional direclidine and bipolar study readouts in 2028, and a CRF2 obesity program (NBIP-'2118) planned to enter Phase 1 in H1 2026. The company said its R&D engine targets at least four new Phase 1 and two Phase 2 programs per year and expects an approved medicine every two years by the end of the decade.
Neurocrine Biosciences (Nasdaq: NBIX) will hold its 2025 R&D Day on Tuesday, December 16, 2025 at 12:00 p.m. ET in San Diego. Management will highlight the company’s R&D transformation and its growing neuroscience pipeline and will feature a discussion with key opinion leader John Krystal, M.D. from Yale.
The event will be available via a live webcast on the company’s Investor website, with a replay and the R&D Day presentation posted approximately one hour after the event and archived for about one month.
Neurocrine Biosciences (Nasdaq: NBIX) announced publication of a peer‑reviewed narrative review in CNS Spectrums that consolidates pharmacologic, pharmacokinetic and >10 years of clinical research on two FDA‑approved VMAT2 inhibitors for tardive dyskinesia.
The review highlights a distinctive profile for INGREZZA (valbenazine), noting selective VMAT2 targeting, metabolism to a single potent metabolite, a therapeutic response at the lowest available 40 mg dose, simplified no‑titration dosing and extensive long‑term efficacy and tolerability data across diverse patient populations.
A supplemental reference guide accompanies the manuscript to support dosing, drug interaction and clinical decision considerations.
Neurocrine Biosciences (Nasdaq: NBIX) said members of its management team will present at two investor conferences: a Jefferies Global Healthcare Conference fireside chat on November 18, 2025 at 12:00 PM GMT (7:00 AM ET) in London, and a Piper Sandler 37th Annual Healthcare Conference fireside chat on December 2, 2025 at 9:30 AM ET in New York.
Both presentations will be live webcast via the company's Investors page at www.neurocrine.com. Replays will be posted about one hour after each event and will be archived for approximately one month.
Neurocrine Biosciences (Nasdaq: NBIX) announced top-line results from a Phase 2 signal-seeking study of NBI-1070770 in adults with major depressive disorder (MDD) on Nov 10, 2025.
The study enrolled 73 adults with inadequate response to at least one antidepressant. The compound did not meet the primary endpoint versus placebo. NBI-1070770 was reported to be generally well tolerated. Company management said it will continue data analyses to determine next steps.
Neurocrine Biosciences (Nasdaq: NBIX) reported third-quarter 2025 results on Oct 28, 2025: Total net product sales $790M (+28% YoY, +16% sequential).
INGREZZA sales were $687M (+12% YoY, +10% sequential) with record new patient starts; CRENESSITY sales were $98M with 540 new patient enrollment start forms and ~80% reimbursement coverage.
Third-quarter GAAP net income was $209.5M (EPS $2.04); non-GAAP net income was $222.1M (EPS $2.17). Cash and marketable securities totaled about $2.11B. Company reaffirmed full-year INGREZZA guidance of $2.5B–$2.55B and provided 2025 R&D and SG&A ranges.
Neurocrine Biosciences (NASDAQ: NBIX) presented a post‑hoc analysis from the Phase 3 KINECT 4 study showing that continuous treatment with INGREZZA 40 mg once daily produced rapid, sustained, clinically meaningful improvements in tardive dyskinesia (TD) over 48 weeks.
Key outcomes: mean AIMS total score change exceeded the minimally clinically important difference at all post‑baseline visits; 90% (18/20) of participants who completed 48 weeks on continuous 40 mg reached ≥50% AIMS improvement; patients who reduced from 80 mg to 40 mg showed similar benefit. Safety was consistent with the known profile, with most adverse events mild/moderate and the most common being sleepiness and tiredness. Findings were presented October 15–18, 2025 at the American Psychiatric Nurses Association conference.
Neurocrine Biosciences (NASDAQ: NBIX) will release its third quarter 2025 financial results and host a conference call and webcast on October 28, 2025. The press release is scheduled for 1:00 p.m. PT / 4:00 p.m. ET, followed by the conference call at 1:30 p.m. PT / 4:30 p.m. ET.
Dial-in numbers: Domestic 800-274-8461, International 203-518-9814 with Conference ID: NBIX. The webcast will be available on the company's Investors page at neurocrine.com, with a replay posted about one hour after the event and archived for ~one month.
Neurocrine Biosciences (Nasdaq: NBIX) announced on October 6, 2025 the appointment of Mike Sibley as Senior Vice President and General Manager of its Neuropsychiatry franchise.
Sibley will lead sales and marketing strategy for Neurocrine's neuropsychiatry products, including the INGREZZA franchise. He brings more than 20 years of commercial biopharma experience and joins after a nine-year tenure at Sanofi, most recently as General Manager for US Dermatology. Prior roles include positions at Galderma, J.P. Morgan Chase & Co., and Johnson & Johnson. Sibley holds a Bachelor of Arts in Economics from the University of Massachusetts, Amherst.