Neurocrine Biosciences Inc Stock Price, News & Analysis

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.

Neurocrine Biosciences (NBIX) reported strong financial results for Q4 and full-year 2024, with INGREZZA net product sales reaching $615M in Q4 and $2.3B for the full year, showing 23% and 26% year-over-year growth respectively. The company received FDA approval for CRENESSITY, a first-in-class treatment for congenital adrenal hyperplasia.

Q4 2024 financial highlights include total revenues of $627.7M, GAAP net income of $103.1M ($1.00 per share), and non-GAAP net income of $173.4M ($1.69 per share). The company ended 2024 with $1.8B in cash and equivalents.

For 2025, NBIX provided guidance for INGREZZA net product sales between $2.5B-$2.6B. The company plans to initiate Phase 3 programs for osavampator in major depressive disorder and NBI-568 in schizophrenia in H1 2025.

Neurocrine Biosciences (NBIX) has scheduled its fourth quarter and year-end 2024 financial results conference call and webcast for February 6, 2025. The earnings press release will be issued at 1:00 PM PT, followed by a conference call at 1:30 PM PT. The company, a leading neuroscience-focused biopharmaceutical firm, focuses on developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders.

The company's portfolio includes FDA-approved treatments for tardive dyskinesia, Huntington's disease chorea, classic congenital adrenal hyperplasia, endometriosis, and uterine fibroids. Additionally, they maintain multiple compounds in mid- to late-phase clinical development across their core therapeutic areas.

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.