Neurocrine Biosciences Inc - NBIX STOCK NEWS

Neurocrine Biosciences (NBIX) has received FDA approval for CRENESSITY™ (crinecerfont), the first new treatment in 70 years for classic congenital adrenal hyperplasia (CAH). The drug is approved as an adjunctive treatment to glucocorticoid replacement for patients aged 4 and older.

The approval is supported by the largest-ever CAH clinical trial program, with significant results in both pediatric and adult studies. In pediatric trials, CRENESSITY showed 4x greater steroid dose reduction versus placebo. In adult trials, 63% of patients achieved glucocorticoid dose reduction while maintaining or improving androgen levels, compared to 18% on placebo.

The drug will be commercially available within a week through PANTHERx Rare pharmacy, with most patients expected to pay $10 or less monthly.

Neurocrine Biosciences (NBIX) has announced its participation in two major investor conferences this December. The company will present at The 7th Annual Evercore HealthCONx Conference on December 3 at 10:50 a.m. ET in Coral Gables, Florida, and Citi's 2024 Global Healthcare Conference on December 4 at 1:45 p.m. ET in Miami.

The presentations will be accessible via webcast on Neurocrine's website, with replays available for approximately one month. The company, focused on neuroscience and biopharmaceuticals, develops treatments for neurological, neuroendocrine, and neuropsychiatric disorders, with FDA-approved treatments for conditions including tardive dyskinesia, Huntington's disease chorea, endometriosis, and uterine fibroids.

Neurocrine Biosciences (NBIX) presented new KINECT-HD study data showing INGREZZA (valbenazine) demonstrated consistent efficacy in reducing chorea across 19 subgroups of Huntington's disease patients. The analysis revealed significant improvements compared to placebo, with a least-squares mean difference of -3.2 in chorea reduction. The study also showed improvements in emotional health aspects, including reduced anger (-1.7 vs -0.2 placebo), feeling overwhelmed (-1.7 vs -0.4), and anxiety (-1.4 vs -0.5). Safety assessments indicated no worsening in anxiety symptoms, depression, or suicidal ideation with INGREZZA treatment.

Neurocrine Biosciences (NBIX) has announced its participation in three major investor conferences this November 2024. The company's leadership team will present at the UBS Global Healthcare Conference on November 12 in Rancho Palos Verdes, the Stifel Healthcare Conference on November 18 in New York, and the Jefferies London Healthcare Conference on November 19 in London.

The presentations will be accessible via webcast on Neurocrine's website, with replays available for approximately one month. Neurocrine Biosciences is a neuroscience-focused biopharmaceutical company developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders, with FDA-approved treatments for conditions including tardive dyskinesia and Huntington's disease chorea.

Neurocrine Biosciences (NBIX) presented data from over 300 patients treated with INGREZZA® for tardive dyskinesia, showing significant improvements across multiple measures. The Phase 3 and 4 studies demonstrated improvements in functional, social, emotional, and health-related quality of life metrics. Notable improvements were observed in self-consciousness (-1.24), embarrassment (-1.19), and mouth noises (-1.05). In real-world practice, 93.9% of patients experienced TD improvement, with 94.2% showing enhanced functional status. The study also reported improved antipsychotic adherence in 52.2% of patients with available data.

Neurocrine Biosciences (NBIX) presented promising long-term data for INGREZZA® (valbenazine) at Psych Congress 2024, showing 59.2% of participants achieved tardive dyskinesia remission at Week 48. The KINECT®-4 study, involving 103 participants, demonstrated that 65% of patients in the 40mg dose group and 57.8% in the 80mg dose group reached remission threshold. Notably, 10% of participants achieved complete resolution with a total AIMS score of 0. The study defined remission as having minimal or no symptoms across all body regions measured by the Abnormal Involuntary Movement Scale.

Neurocrine Biosciences (NBIX) reported strong Q3 2024 financial results, with INGREZZA net product sales reaching $613 million, representing a 26% year-over-year growth. The company raised its 2024 INGREZZA sales guidance to $2.30-$2.32 billion. Total revenues for Q3 2024 were $622.1 million, with GAAP net income of $129.8 million ($1.24 per share). The Board authorized a $300 million share repurchase plan. The company maintains a strong balance sheet with $1.87 billion in cash and marketable securities. Growth was driven by strong patient demand and improved gross-to-net dynamics across tardive dyskinesia and Huntington's disease chorea indications.

Neurocrine Biosciences (Nasdaq: NBIX) has announced its schedule for the third quarter 2024 financial results conference call and webcast. The event is set for October 30, 2024, with the press release at 4:00 a.m. PT and the conference call at 5:00 a.m. PT. Investors can access the webcast on the company's website, with a replay available for approximately one month.

Neurocrine Biosciences is a neuroscience-focused biopharmaceutical company dedicated to developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders. The company's portfolio includes FDA-approved treatments for tardive dyskinesia, Huntington's disease-associated chorea, endometriosis, and uterine fibroids. They also have multiple compounds in mid- to late-phase clinical development across their core therapeutic areas.

Neurocrine Biosciences (Nasdaq: NBIX) presented interim results from the KINECT®-HD2 study of INGREZZA® (valbenazine) for treating chorea in Huntington's disease. The study showed robust and sustained improvements in chorea through Week 104, regardless of antipsychotic use. Key findings include:

- Improved chorea as early as Week 2 (-3.4 TMC score change) with 40 mg dose
- Sustained efficacy from Week 8 (-5.7) to Week 104 (-5.2) with up to 80 mg dose
- Over 50% of participants rated symptoms as 'much improved' or 'very much improved' from Week 6 onwards
- At Week 104, 75.9% of participants self-reported improvement, with 73.6% clinician-assessed improvement

The most common side effects were falls, somnolence, and fatigue. This study is significant as it's the first to include patients taking antipsychotics in a VMAT2 inhibitor trial for Huntington's disease chorea.