Neurocrine Biosciences Inc - NBIX STOCK NEWS

Neurocrine Biosciences (Nasdaq: NBIX) has announced its Q2 2024 financial results conference call and webcast scheduled for August 1, 2024, at 5:00 a.m. PT (8:00 a.m. ET). The press release will be issued at 4:00 a.m. PT (7:00 a.m. ET) on the same day. Domestic participants can dial 800-445-7795, while international callers can use 785-424-1699 with the conference ID 'NBIX'.

The webcast will be accessible via Neurocrine's website under the Investors section. A replay will be available an hour after the event and archived for a month. Neurocrine Biosciences is a neuroscience-focused biopharma company, offering FDA-approved treatments for various neurological and neuroendocrine disorders and has a strong pipeline of therapies in development.

Neurocrine Biosciences (Nasdaq: NBIX) announced that the U.S. FDA has accepted two New Drug Applications (NDAs) for crinecerfont, with Priority Review designations, for treating classic congenital adrenal hyperplasia (CAH) in children, adolescents, and adults. The FDA has set target action dates in late December 2024 and does not plan to hold an advisory committee meeting. Crinecerfont, a highly selective CRF1 antagonist, could become the first new CAH treatment in 70 years. The NDAs cover capsule and oral solution formulations. Crinecerfont has previously received Orphan Drug and Breakthrough Therapy designations, the latter based on positive Phase 3 study results. If approved, Neurocrine will activate its Rare Pediatric Disease Designation Priority Review Voucher, potentially benefiting from market exclusivity and tax incentives.

Neurocrine Biosciences and Diurnal presented new data on their neuroendocrinology pipeline at ENDO 2024. The CAHtalyst™ Phase 3 studies of crinecerfont for congenital adrenal hyperplasia (CAH) showed that crinecerfont effectively reduced high glucocorticoid (GC) doses and androgen levels in pediatric and adult patients. The studies met their primary and secondary endpoints, achieving significant reductions in GC dosing. Additionally, data from the CAHtalog™ Registry highlighted the negative impacts of high GC doses, including increased rates of obesity, hypertension, and metabolic complications. Real-world data suggested that current GC therapies have numerous adverse effects. The findings underscore the need for better treatment options for CAH.

Neurocrine Biosciences announced the publication of its CAHtalyst Pediatric Phase 3 study results in The New England Journal of Medicine, showcasing crinecerfont's efficacy in treating congenital adrenal hyperplasia (CAH). The study met both primary and key secondary endpoints, with crinecerfont successfully lowering androstenedione levels and allowing glucocorticoid dose reduction while maintaining androgen control. Notably, 30% of participants on crinecerfont achieved a physiologic glucocorticoid dose at 28 weeks, compared to 0% in the placebo group. The treatment also exhibited favorable trends in mitigating long-term effects of high-dose glucocorticoid and androgen excess, with improvements in body weight, insulin resistance, and hirsutism. Crinecerfont was generally well tolerated, with common adverse events including headache, fever, and vomiting.

Neurocrine Biosciences announced that the CAHtalyst™ Phase 3 study results of crinecerfont for treating adults with congenital adrenal hyperplasia (CAH) were published in the New England Journal of Medicine. The study met its primary and key secondary endpoints, showing significant reductions in glucocorticoid (GC) doses while maintaining androgen control. 62.7% of crinecerfont-treated participants achieved a physiologic GC dose versus 17.5% with placebo. Crinecerfont was generally well tolerated, with the most common adverse events being fatigue and headache. The study involved 182 participants, with over 95% completing the 24-week double-blind period.

Crinecerfont reduced androstenedione levels more than placebo, demonstrating its efficacy through a GC-independent mechanism. Participants saw improvements in metrics related to long-term GC therapy such as body weight and glucose tolerance. The treatment showed no major safety concerns, with few serious adverse events reported.

Neurocrine Biosciences (Nasdaq: NBIX) will participate in two investor conferences in June 2024. The company’s top executives, including CEO Kevin Gorman, Chief Business Development and Strategy Officer Kyle Gano, and CFO Matt Abernethy, will present at the Jefferies Global Healthcare Conference on June 5 in New York and the Goldman Sachs 45th Annual Global Healthcare Conference on June 13 in Miami. These live presentations will be webcast and accessible on the company's website, with replays available shortly after the events.

Neurocrine Biosciences announced that CEO Kevin Gorman will retire on October 11, 2024, and will be succeeded by Kyle Gano, the current Chief Business Development and Strategy Officer. Gano will also join the Board of Directors. Gorman, who founded the company in 1992, will remain on the Board. Under Gorman's leadership, Neurocrine has evolved into a fully integrated biopharmaceutical company with a robust pipeline and strong financial performance. Key achievements include the launch of INGREZZA and recent FDA submissions for crinecerfont. Neurocrine now has 17 clinical programs and aims to advance its mission in neurology, neuroendocrinology, and neuropsychology.

Neurocrine Biosciences announced the presentation of new Phase 3 CAHtalyst™ data at ENDO 2024, focusing on congenital adrenal hyperplasia (CAH) in both adults and children. The data includes results from randomized, double-blind, placebo-controlled trials evaluating crinecerfont's efficacy, safety, and tolerability. Additional presentations cover modified-release hydrocortisone (MRHC) studies for primary adrenal insufficiency and CAH, analyzing the impact of supraphysiologic glucocorticoid dosing and disease-related comorbidities. These findings have supported New Drug Application submissions to the FDA in April 2024.

The presentations will take place from June 1-4 in Boston, featuring key data and several posters highlighting the company's neuroendocrinology pipeline.

Neurocrine Biosciences announced the publication of a post hoc analysis from the Phase 3 KINECT-4 study on INGREZZA (valbenazine) capsules in the Journal of Clinical Psychopharmacology. The analysis assessed long-term outcomes for tardive dyskinesia (TD) and showed significant, sustained improvements in symptom severity over 48 weeks.

Highlights include a 55% improvement in symptoms by Week 4 on the starting dose, rising to 95% by Week 24, and 97% by Week 48. The study involved 103 participants who showed a mean AIMS score reduction of 10.5 by Week 48.

Overall, 86% of participants achieved at least a 50% improvement, with 52% reaching a 70% improvement threshold. Patient and healthcare professional ratings indicated over 88% of participants showed 'much' or 'very much' improved symptoms. INGREZZA was generally well-tolerated over the study period.