Neurocrine Biosciences Inc - NBIX STOCK NEWS

Neurocrine Biosciences (NBIX) reported positive Phase 2 data for NBI-1117568, an oral muscarinic M4 selective agonist for schizophrenia treatment. The once-daily 20 mg dose met the primary endpoint, showing a statistically significant 7.5-point improvement (p=0.011, 0.61 effect size) in the PANSS Total Score compared to placebo at Week 6. It also demonstrated an 18.2-point PANSS Total Score improvement from baseline.

The 20 mg dose met additional endpoints, including improvements in Clinical Global Impression of Severity Scale and Marder Factor Scores. NBI-'568 was generally safe and well-tolerated at all doses studied. The efficacy, safety, and tolerability results support advancement to Phase 3 in early 2025.

Neurocrine Biosciences (NBIX) will present at the Canaccord Genuity 44th Annual Growth Conference in Boston on August 14, 2024, at 3:30 p.m. Eastern Time. Kyle Gano, Chief Business Development and Strategy Officer, and Todd Tushla, Vice President of Investor Relations, will represent the company. The presentation will be webcast live and accessible on Neurocrine'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. Their portfolio includes FDA-approved treatments for tardive dyskinesia, Huntington's disease-associated chorea, endometriosis, and uterine fibroids. The company has a robust pipeline with multiple compounds in mid to late-phase clinical development.

Neurocrine Biosciences (NBIX) reported strong Q2 2024 financial results, with INGREZZA net product sales reaching $580 million, a 32% year-over-year increase. The company raised its 2024 INGREZZA sales guidance to $2.25 - $2.3 billion. Total revenues for Q2 were $590.2 million, up from $452.7 million in Q2 2023. GAAP net income was $65 million ($0.63 per share), while Non-GAAP net income was $169 million ($1.63 per share). The company maintains a strong cash position of $1.68 billion. Neurocrine also announced FDA Priority Review for crinecerfont in congenital adrenal hyperplasia and positive Phase 2 data for NBI-1065845 in major depressive disorder. CEO Kevin Gorman will retire in October, to be succeeded by Kyle Gano.

Neurocrine Biosciences (Nasdaq: NBIX) has launched INGREZZA® SPRINKLE (valbenazine) capsules, a new sprinkle formulation of their #1 prescribed VMAT2 inhibitor for tardive dyskinesia and Huntington's disease chorea. This new formulation aims to ease administration for patients with dysphagia or difficulty swallowing.

Key points:

• INGREZZA SPRINKLE offers the same dosing options (40 mg, 60 mg, 80 mg) as regular INGREZZA
• It can be sprinkled on soft food for easier consumption
• The cost is equivalent to regular INGREZZA
• Most patients pay $10 or less out-of-pocket through the INBRACE® Support Program

This launch addresses a significant need, as 37% of TD patients with moderate-to-severe symptoms report difficulty eating and drinking due to involuntary movements.

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.