Neurocrine Biosciences Inc Stock Price, News & Analysis

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.

Neurocrine Biosciences, along with Diurnal, presented data from their CAHtalyst™ Phase 3 studies and CHAMPAIN Phase 2 study at the European Congress of Endocrinology 2024. The CAHtalyst studies focused on congenital adrenal hyperplasia (CAH) in children and adults, revealing limitations in current treatments. Despite high doses of glucocorticoids, participants showed elevated adrenal androgen levels and comorbidities like obesity and advanced bone age.

CHAMPAIN Phase 2 study of modified-release hydrocortisone (MRHC) in adults with primary adrenal insufficiency showed that 45 out of 49 participants achieved physiological morning cortisol levels after four weeks, compared to only 2 on Plenadren.

The Phase 3 extension study of MRHC in CAH patients demonstrated a reduction in median daily hydrocortisone dose and an increase in responders achieving targeted hormone levels.

These findings highlight the potential of MRHC in improving hormonal control and reducing glucocorticoid use in CAH and adrenal insufficiency patients.

Neurocrine Biosciences presented data from the CAHtalyst™ Adult Study, highlighting the need for new treatment options in congenital adrenal hyperplasia (CAH) patients. Baseline characteristics revealed the long-term consequences of current treatments, with patients experiencing disorders typically found in older individuals. A literature review showed an increased risk of psychiatric and cognitive symptoms in CAH patients receiving high glucocorticoid doses. These findings were presented at the AACE 2024 Annual Meeting.

Neurocrine Biosciences, Inc. (Nasdaq: NBIX) has initiated a Phase 1 clinical study for the investigational compound NBI-1076986 targeting movement disorders. The study aims to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy adults. This compound, an M4 subtype-selective muscarinic acetylcholine receptor antagonist, shows promise for treating conditions like Parkinson's disease tremor and dystonia.

Neurocrine Biosciences, Inc. (Nasdaq: NBIX) has initiated a Phase 1 clinical study for NBI-1117567, an oral muscarinic agonist, to evaluate its safety and efficacy in healthy adults. The compound aims to treat neurological and neuropsychiatric conditions, potentially improving cognition in patients with psychosis.

Neurocrine Biosciences, Inc. (NBIX) will present at the BofA Securities 2024 Health Care Conference, featuring top executives discussing the company's commitment to developing life-changing treatments for neurological disorders. The conference will be webcasted live and a replay will be available on the company's website. Neurocrine Biosciences has a strong portfolio of FDA-approved treatments and a robust pipeline in late-stage development.

Neurocrine Biosciences, Inc. (Nasdaq: NBIX) will present key information at the European Congress of Endocrinology 2024, including baseline characteristics data from CAHtalyst™ Program of crinecerfont in CAH, and data from modified-release hydrocortisone studies in primary adrenal insufficiency and CAH. The presentations will cover pediatric and adult baseline characteristics data in congenital adrenal hyperplasia, Phase 2 Clinical Study Data for Modified-Release Hydrocortisone, Phase 3 Extension Study Data for Modified-Release Hydrocortisone in CAH, and more.

Neurocrine Biosciences, Inc. (NBIX) supports Tardive Dyskinesia Awareness Week to advocate for routine screening and monitoring of TD, a movement disorder caused by antipsychotic medication affecting approximately 600,000 people in the U.S. annually.

Neurocrine Biosciences presented CAHtalyst™ Pediatric Study Baseline Characteristics and CAHtalog™ Registry Data at PES 2024, highlighting the need for novel treatments in children and adolescents with Congenital Adrenal Hyperplasia (CAH). The data showcased the challenges in long-term CAH management, emphasizing the limitations of current treatment approaches and the difficulties in disease management as patients age into adulthood. Additionally, positive top-line data from previous Phase 3 clinical studies supported two New Drug Applications submitted to the FDA in April 2024.