NEUROCRINE BIOSCIENCES (NBIX) Company Report

Neurocrine Biosciences announced the presentation of head-to-head data demonstrating that its drug, INGREZZA (valbenazine) capsules, achieved significantly higher vesicular monoamine transporter 2 (VMAT2) target occupancy compared to AUSTEDO XR (deutetrabenazine).
The study, presented at the American College of Neuropsychopharmacology 64th Annual Meeting, found that INGREZZA showed nearly two-fold higher VMAT2 occupancy than AUSTEDO XR after a single dose.
Specifically, the primary analysis showed a least squares mean VMAT2 occupancy of approximately 76.5% for INGREZZA compared with approximately 38.3% for AUSTEDO XR at therapeutic doses.
VMAT2 occupancy is a key measurement associated with drug response in involuntary movement disorders such as tardive dyskinesia and Huntington's disease chorea, for which INGREZZA is approved.

3 hours ago

Press Release

Neurocrine Biosciences Provides 2025 Insights and Outlines 2026 Strategic Priorities at J.P. Morgan Conference

NBIX

Guidance Update

Product Launch

New Projects/Investments

Neurocrine Biosciences provided 2025 insights, guiding INGREZZA net sales to $2.5 billion-$2.55 billion and reporting CRENESITY net sales of $166 million for the first nine months.
The company highlighted two overarching themes for 2026: strong and building momentum and strategic balanced diversification.
The first year of CRENESITY's launch exceeded expectations, demonstrating faster patient uptake, favorable reimbursement, and high patient persistence, achieving approximately 10% market penetration of the estimated 20,000 classic CAH patients in the U.S..
New two-year data for CRENESITY showed robust, sustained clinically meaningful benefits in adults and pediatric patients with classic CAH, including steroid reduction, weight loss in obese/overweight patients, and slowed bone age advancement in pre-pubertal children, alongside a favorable safety profile with 35,000 patient weeks of exposure.
Neurocrine's R&D engine is fully operational, targeting four new Phase I, two new Phase II, and a sustained Phase III portfolio of at least three programs annually, with plans to initiate six new Phase I programs in 2026 across neuropsychiatry, endocrinology, and immunology.

3 days ago

Transcript

Neurocrine Highlights Strong 2025 Performance and Strategic Diversification at J.P. Morgan Healthcare Conference

NBIX

Guidance Update

Product Launch

New Projects/Investments

Neurocrine provided 2025 net sales guidance for Ingrezza of $2.5-$2.55 billion and reported $166 million in net sales for Crinecerfont during its first nine months of commercialization.
The first year of launch for Crinecerfont exceeded expectations in uptake, reimbursement, and patient persistence, achieving approximately 10% market penetration among the estimated 20,000 classic CAH patients in the U.S..
The company is undergoing a sales force expansion for both Ingrezza and Crinecerfont and has diversified its portfolio to include four FDA-approved medicines and a pipeline of 12 programs in clinical development across various modalities.
Neurocrine's R&D engine aims to deliver one new medicine every two years by the end of the decade, with plans to initiate six new phase one programs and four new phase two trials in the current year.
Key upcoming catalysts include phase three readouts for Osovampator and Derecladine in 2027, alongside early phase one data for gene therapy and weight loss programs.

3 days ago

Transcript

Neurocrine Biosciences Provides 2025 Performance Update and Pipeline Progress

NBIX

Guidance Update

Product Launch

New Projects/Investments

Neurocrine Biosciences reported 2025 net sales guidance for Ingrezza of $2.5-$2.55 billion and $166 million in net sales for Crinecerfont during its first nine months of commercialization.
The company's R&D engine is fully operational, with 12 programs in clinical development (eight in Phase 1, two in Phase 2, and two in Phase 3), and aims to deliver one new medicine every two years by the end of the decade.
Crinecerfont's first year of launch for Classic Congenital Adrenal Hyperplasia (CAH) exceeded expectations, achieving approximately 10% penetration of the estimated 20,000 U.S. CAH patients.
New two-year open-label extension data for Crinecerfont demonstrated robust, sustained clinically meaningful benefits, including a predicted adult height increase of ~5.5 cm in a subset of pediatric patients and 5% or greater weight loss in ~40% of obese/overweight adult patients.
The pipeline is expanding into new therapeutic areas and modalities, including MBIP2118 for obesity and a next-generation Crinecerfont peptide (MPIP1435) for CAH, both in Phase 1 development.

3 days ago

Transcript

Neurocrine Biosciences provides update on Phase 3 study results

NBIX

New Projects/Investments

Neurocrine Biosciences announced that its Phase 3 KINECT®-DCP study evaluating valbenazine for dyskinetic cerebral palsy (DCP) did not meet primary or key secondary endpoints.
The study's primary objective was to assess improvement in chorea, a type of involuntary movement, in pediatric and adult participants with DCP.
Valbenazine is already FDA-approved for tardive dyskinesia (2017) and chorea associated with Huntington's disease (2023).
There are currently no approved treatments for people living with dyskinetic cerebral palsy.

Dec 22, 2025, 9:05 PM

Press Release

Neurocrine Biosciences Outlines R&D Strategy and Pipeline Progress at 2025 R&D Day

NBIX

New Projects/Investments

Neurocrine Biosciences is transitioning from a single-product biotech to a multi-product diversified biopharmaceutical company with two commercial products and 2,000 employees.
The company's neuropsychiatry portfolio is positioned to deliver multiple best- and first-in-class medicines by 2030, with key programs like Osirvampetor for major depressive disorder and Direclidine for schizophrenia, both with Phase 3 data expected in 2027. Osirvampetor demonstrated statistically significant efficacy in Phase 2, with a 7.5 MADRS score decrease at two months.
Neurocrine is expanding its CRF biology expertise with a two-pronged strategy, including follow-on CRF1 medicines and new CRF2 agonists for metabolic disorders like obesity, with MBIP-2118 entering the clinic in the first half of next year for weight loss with muscle preservation.
The transformed R&D engine has delivered 24 new development candidates over the past three years, exceeding its target, and aims for one launch product every other year. The early-phase pipeline currently includes 9 assets in Phase 1 and 15 additional development candidates in IND-enabling studies.

Dec 16, 2025, 5:00 PM

Transcript

Neurocrine Outlines 2026 R&D Strategy and Pipeline Progress

NBIX

New Projects/Investments

Product Launch

Neurocrine is implementing a "20 in 5" R&D strategy, targeting 20 new development candidates over five years and the launch of one new medicine every two years at steady state.
The company achieved its productivity goal in 2025 for the first time, with four new Phase 1 starts, two new Phase 2 starts, and three programs in Phase 3.
Strategic R&D pillars include leading the VMAT2 category with next-generation inhibitors and expanding CRF biology into new areas like metabolic diseases, leveraging a shift to multimodality (peptides, biologics).
Phase 3 studies for Osirvampetor, an AMPA potentiator for depression, are enrolling well, with top-level readouts anticipated in the 2027 time frame.
A novel, potent Q-weekly CRF2 agonist for metabolic disease, specifically obesity with muscle preservation, is slated to enter the clinic in the first half of next year (2026).

Dec 16, 2025, 5:00 PM

Transcript

Neurocrine Biosciences Outlines R&D Transformation and Pipeline Strategy at 2025 R&D Day

NBIX

New Projects/Investments

Guidance Update

Neurocrine Biosciences is transitioning to a multi-product biopharmaceutical company, targeting the delivery of one new medicine every two years and multiple best- and first-in-class medicines by 2030.
The company's transformed R&D engine has delivered 24 new development candidates in the past three years and is now at a steady state of four new phase I starts, two new phase II starts, and three programs in phase III annually.
Key pipeline updates include anticipated top-line data for Osavampator (major depressive disorder) phase III studies in 2027, and for Direclidine (schizophrenia and bipolar mania) phase III/II studies in 2027-2028.
Neurocrine is leveraging its expertise in CRF biology for new programs, including NBIP-'2118 for metabolic disorders, which will enter the clinic in the first half of 2026.

Dec 16, 2025, 5:00 PM

Transcript

Neurocrine Biosciences Discusses Product Performance, IRA Impact, and Growth Strategy

NBIX

Product Launch

M&A

Guidance Update

Neurocrine Biosciences reported strong performance for Ingrezza, projected to reach approximately $2.5 billion this year, and a successful launch for Crinecerfont, which has aided 10% of congenital adrenal hyperplasia (CAH) patients since its approval a year ago.
The company anticipates the Inflation Reduction Act (IRA) impact on Ingrezza to be very manageable from 2027 to 2029, with current formulary coverage secured for over 70% of Medicare lives and over 90% in Medicaid and commercial through 2026.
Neurocrine is expanding its Ingrezza and Crinecerfont sales teams in 2026 to drive growth, particularly targeting advanced practice providers who represent a rapidly expanding prescriber base in the VMAT2 category.
With $2 billion in cash and no debt, Neurocrine is actively seeking business development opportunities for commercial products that can leverage its existing infrastructure within the next three to five years, focusing on neuro, endocrine, and adjacent therapeutic areas.

Dec 2, 2025, 2:30 PM

Transcript

Neurocrine Biosciences Discusses Product Performance, IRA Impact, and Growth Strategy

NBIX

Product Launch

M&A

Guidance Update

Ingrezza is performing strongly, with sales around $2.5 billion this year, and has significant room for growth as only 10% of tardive dyskinesia patients are currently treated with VMAT2 inhibitors.
The launch of Crinecerfont for congenital adrenal hyperplasia (CAH) has been successful, helping 10% of CAH patients within a year of its December last year approval, with high patient persistency (over 90%).
Neurocrine views the impact of the Inflation Reduction Act (IRA) on Ingrezza as manageable from 2027 to 2029, expecting to maintain coverage and negotiate a favorable price for 2029 implementation.
The company is expanding its Ingrezza and Crinecerfont sales teams in 2026 to capitalize on market momentum and the growing base of VMAT2 prescribers, particularly advanced practice providers.
With $2 billion in cash and no debt, Neurocrine is actively considering business development opportunities, focusing on commercial products in neuro, endocrine, and adjacent spaces that could launch in the next three to five years.

Dec 2, 2025, 2:30 PM

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