Neurocrine Biosciences Inc Stock Price, News & Analysis

Neurocrine Biosciences (NASDAQ: NBIX) has launched "ConnectING with Carnie™," a multimedia awareness campaign featuring Grammy-nominated singer Carnie Wilson. The campaign focuses on tardive dyskinesia (TD), an involuntary movement disorder caused by antipsychotic medications. While Wilson doesn't have TD herself, she will serve as an advocate to reduce stigma and encourage patients to seek treatment.

The initiative aims to empower individuals with TD to discuss their symptoms openly and explore treatment options, including INGREZZA® (valbenazine) capsules. The campaign will feature video interviews and resources on ConnectingWithCarnie.com, sharing stories from TD patients, care partners, and healthcare professionals about their experiences with the condition and its treatment.

Neurocrine Biosciences has launched a Phase 3 registrational program to test NBI-1117568, an oral muscarinic M4 selective orthosteric agonist, for treating adults with schizophrenia. This advancement follows successful Phase 2 results from August 2024.

The Phase 3 trial will be a global, double-blind, placebo-controlled study involving approximately 280 adult patients with schizophrenia experiencing acute symptom exacerbation. The study's primary goal is to measure reduction in the Positive and Negative Syndrome Scale (PANSS), with a secondary focus on the Clinical Global Impression of Severity (CGI-S) scale.

Phase 2 results showed promising outcomes with the 20 mg daily dose, including:

• A significant PANSS score reduction of 7.5 points versus placebo
• An 18.2-point reduction from baseline
• Improvements in secondary endpoints
• Good safety profile with minimal side effects

Neurocrine Biosciences (NBIX) has published a groundbreaking post-hoc analysis in The Journal of Clinical Psychiatry, demonstrating INGREZZA's long-term efficacy and safety in treating tardive dyskinesia (TD) in adults aged 65 and older.

The analysis, pooling data from two 48-week studies (KINECT 3 extension and KINECT 4), included 304 participants, with 55 (18.1%) aged ≥65 years. Key findings show that older adults achieved substantial TD symptom improvements within 8 weeks, sustained through 48 weeks:

• 95% of patients on INGREZZA 80mg showed ≥30% improvement in AIMS scores
• 95% on 80mg demonstrated CGI-TD improvements
• 90% on 80mg reported PGIC improvements

The safety profile remained consistent with no new treatment-emergent adverse events of clinical concern compared to younger adults. Common side effects included urinary tract infection and somnolence, each affecting 6 of 55 older participants.

Neurocrine Biosciences (NBIX) has scheduled its first quarter 2025 financial results conference call and webcast for May 5, 2025, at 1:30 p.m. Pacific Time. The company will release its Q1 2025 financial results via press release at 1:00 p.m. PT on the same day.

Neurocrine Biosciences is a neuroscience-focused biopharmaceutical company with FDA-approved treatments for various conditions including tardive dyskinesia, Huntington's disease chorea, congenital adrenal hyperplasia, endometriosis, and uterine fibroids. The company maintains a pipeline of compounds in mid- to late-phase clinical development across its core therapeutic areas.

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.