Neurocrine Biosciences Inc Stock Price, News & Analysis

Neurocrine Biosciences (NBIX) has appointed Dr. Sanjay Keswani as Chief Medical Officer (CMO), effective June 2, 2025. Dr. Keswani, bringing over 20 years of pharmaceutical industry experience, will lead clinical development and medical affairs activities.

Dr. Keswani succeeds Dr. Eiry W. Roberts, who served as CMO for seven years and will transition to a strategic advisory role. His previous positions include CEO of ImmunoBrain, SVP and R&D Head at Hoffman La Roche, and VP at Bristol-Myers Squibb.

During her tenure, Dr. Roberts led key developments including INGREZZA indication expansion and the crinecerfont program resulting in FDA approval of CRENESSITY. She also oversaw successful Phase 2 studies for osavampator and NBI-1117568, both advancing to registrational programs this year.

Neurocrine Biosciences (NBIX) presented new real-world data comparing therapeutic dose attainment between INGREZZA and deutetrabenazine in tardive dyskinesia treatment. The retrospective study (2022-2024) analyzed 3,527 INGREZZA patients, 2,166 deutetrabenazine BID patients, and 326 deutetrabenazine XR patients.

Key findings showed that 100% of INGREZZA patients reached therapeutic doses from day one, while only 47.5% of deutetrabenazine BID and 54.3% of deutetrabenazine XR patients achieved therapeutic doses within six months. Among deutetrabenazine patients who reached therapeutic doses, nearly 10% couldn't maintain them.

The study also revealed that INGREZZA patients experienced fewer dose changes (33.7%) compared to deutetrabenazine patients (BID: 48.1%; XR: 54.0%) after the first month of treatment.

Neurocrine Biosciences (NBIX) has presented new long-term data from the KINECT® 4 study showing significant remission rates in tardive dyskinesia patients treated with INGREZZA® (valbenazine). The 48-week study involved 103 participants and demonstrated that 59.2% achieved remission, with consistent results across different doses and psychiatric conditions.

The study showed remarkable AIMS score improvements, with patients on 40 mg doses seeing scores decrease from 12.4 to 2.1, and those on 80 mg doses improving from 15.1 to 2.5. Specifically, 58.6% of participants on the 40 mg dose and 59.5% on the 80 mg dose achieved remission. The treatment proved effective across different psychiatric diagnoses, with 57.7% of schizophrenia/schizoaffective disorder patients and 62.5% of mood disorder patients reaching remission thresholds.

Neurocrine Biosciences (NBIX) has presented new data from the KINECT®-HD study demonstrating significant improvements in chorea symptoms with INGREZZA® (valbenazine) capsules in Huntington's disease patients. The post-hoc analysis, presented at the 2025 American Association of Neuroscience Nurses Symposium, showed consistent benefits across body regions.

The Phase 3 clinical trial involved 125 patients randomized to receive either INGREZZA (n=64) at doses of 40mg, 60mg, or 80mg, or placebo (n=61) over 12 weeks. The study measured chorea severity using the UHDRS® Total Maximal Chorea score across seven body regions.

Key findings revealed:

• More participants showed meaningful chorea improvements with INGREZZA versus placebo across all affected body regions
• Statistically significant improvements were observed in upper and lower extremities (P<0.05)
• Greatest improvements were seen in arms and legs, which had the highest severity at baseline

Neurocrine Biosciences (NBIX) has announced its participation in the Stifel 2025 Virtual CNS Forum scheduled for Tuesday, March 18, 2025, at 1:30 p.m. Eastern Time. CEO Kyle Gano and CMO Eiry Roberts will lead the presentation, which will be accessible via webcast on the company's investor relations website.

Neurocrine Biosciences is a prominent neuroscience-focused biopharmaceutical company specializing in treatments for neurological, neuroendocrine, and neuropsychiatric disorders. The company's portfolio includes FDA-approved treatments for multiple conditions including tardive dyskinesia, Huntington's disease-associated chorea, classic congenital adrenal hyperplasia, endometriosis, and uterine fibroids. Their pipeline features several compounds in mid to late-phase clinical development.

Neurocrine Biosciences (NBIX) has initiated a Phase 1 clinical study of NBI-1140675, their new second-generation VMAT2 inhibitor, in healthy adults. The study will evaluate the compound's safety, tolerability, pharmacokinetics and pharmacodynamics.

NBI-1140675 is an oral, selective small molecule inhibitor designed for treating neurological and neuropsychiatric conditions. It joins NBI-1065890 as the company's second VMAT2 inhibitor in Phase 1 trials.

This development builds on Neurocrine's track record with valbenazine, their first VMAT2 inhibitor, which received FDA approval for tardive dyskinesia treatment in 2017 and for Huntington's disease chorea in 2023. Valbenazine is currently in Phase 3 trials for schizophrenia and dyskinetic cerebral palsy.

Neurocrine Biosciences (NBIX) has reported positive top-line data from its Phase 4 KINECT-PRO™ study of INGREZZA® for tardive dyskinesia (TD). The study, involving 59 patients over 24 weeks, demonstrated significant improvements in patients' quality of life and functionality, regardless of TD severity or underlying psychiatric conditions.

The trial evaluated patients using multiple validated scales, including the Tardive Dyskinesia Impact Scale, showing meaningful improvements in physical, social, and emotional impacts. Patients received daily INGREZZA doses of 40mg, 60mg, or 80mg, with 52 participants completing the full 24-week period.

Key findings showed sustained improvements across all patient-reported outcome measures, with benefits observed as early as four weeks at the lowest dose. The study reported consistent safety profile with no new concerns identified. This marks the first study demonstrating patient-reported impact of a vesicular monoamine transporter 2 inhibitor specifically for TD treatment.

Neurocrine Biosciences (NBIX) has announced its participation in two major investor conferences this March. The company's leadership team will present at the TD Cowen 45th Annual Health Care Conference on March 4, 2025, in Boston, and the Leerink Global Healthcare Conference on March 11, 2025, in Miami.

The presentations will be accessible via live webcasts on the company's investor relations website, with replays available for approximately one month after the events. Neurocrine Biosciences is a neuroscience-focused biopharmaceutical company specializing in treatments for neurological, neuroendocrine, and neuropsychiatric disorders. Their portfolio includes FDA-approved treatments for conditions such as tardive dyskinesia, Huntington's disease chorea, congenital adrenal hyperplasia, endometriosis, and uterine fibroids.

Neurocrine Biosciences (NBIX) has announced a new $500 million share repurchase program, following the completion of a $300 million accelerated repurchase program from October 2024 to February 2025. The new authorization allows for various repurchase methods, including open-market transactions, privately negotiated deals, and accelerated share repurchases.

The company's Board Chairman, William Rastetter, stated this decision aligns with their capital allocation strategy, which balances revenue growth through investment in commercial products INGREZZA and CRENESSITY, advancement of R&D pipeline, and returning capital to shareholders.