Neurocrine Biosciences Inc - NBIX STOCK NEWS

Neurocrine Biosciences (NBIX) announced the publication of a narrative review discussing challenges in treating classic congenital adrenal hyperplasia (CAH) with traditional glucocorticoids (GCs) and potential benefits of new non-GC treatments. The review, published in Expert Review of Endocrinology & Metabolism, highlights how non-GC mechanisms could enable lower, more physiologic GC dosing while managing excess ACTH and androgens.

The publication emphasizes that chronic exposure to high-dose GC treatment can lead to severe cardiovascular, metabolic, and skeletal complications, affecting patients' mental health and quality of life. The FDA recently approved CRENESSITY™ (crinecerfont), the first and only classic CAH treatment that directly reduces excess ACTH and adrenal androgen production, allowing for GC dose reduction in patients four years and older.

Neurocrine Biosciences (NBIX) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. The presentation is scheduled for Monday, January 13, 2025, at 8:15 a.m. Pacific Time.

Chief Executive Officer Kyle Gano will deliver the company's presentation, which will be accessible through a live webcast on the company's website under the Investors section at www.neurocrine.com. For those unable to attend the live event, a replay will be made available approximately one hour after the presentation concludes and will remain accessible for about one month.

Neurocrine Biosciences (NBIX) announced the commercial availability of CRENESSITY™ (crinecerfont) in the United States. The drug, recently FDA-approved, is a first-in-class treatment for classic Congenital Adrenal Hyperplasia (CAH) in patients aged 4 and older. CRENESSITY is exclusively distributed through PANTHERx Rare pharmacy, with 24/7 CAH-trained pharmacist support.

As an adjunctive treatment to glucocorticoid replacement, CRENESSITY allows patients to take lower doses of glucocorticoids while maintaining or improving androgen levels. The company expects 90% of patients will have a monthly copay of $12 or less, supported by their comprehensive Neurocrine Access Support program.

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.