Neurocrine Biosciences Inc - NBIX STOCK NEWS

Neurocrine Biosciences (NBIX) reported strong financial results for Q4 and full-year 2024, with INGREZZA net product sales reaching $615M in Q4 and $2.3B for the full year, showing 23% and 26% year-over-year growth respectively. The company received FDA approval for CRENESSITY, a first-in-class treatment for congenital adrenal hyperplasia.

Q4 2024 financial highlights include total revenues of $627.7M, GAAP net income of $103.1M ($1.00 per share), and non-GAAP net income of $173.4M ($1.69 per share). The company ended 2024 with $1.8B in cash and equivalents.

For 2025, NBIX provided guidance for INGREZZA net product sales between $2.5B-$2.6B. The company plans to initiate Phase 3 programs for osavampator in major depressive disorder and NBI-568 in schizophrenia in H1 2025.

Neurocrine Biosciences (NBIX) has scheduled its fourth quarter and year-end 2024 financial results conference call and webcast for February 6, 2025. The earnings press release will be issued at 1:00 PM PT, followed by a conference call at 1:30 PM PT. The company, a leading neuroscience-focused biopharmaceutical firm, focuses on developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders.

The company's portfolio includes FDA-approved treatments for tardive dyskinesia, Huntington's disease chorea, classic congenital adrenal hyperplasia, endometriosis, and uterine fibroids. Additionally, they maintain multiple compounds in mid- to late-phase clinical development across their core therapeutic areas.

Neurocrine Biosciences (NBIX) has initiated a Phase 3 registrational study for osavampator, a potential first-in-class adjunctive treatment for major depressive disorder (MDD). This announcement follows positive topline data from the Phase 2 SAVITRI™ study reported in April 2024, where the drug met its primary and secondary endpoints and showed good tolerability.

The drug aims to address a significant unmet need, as MDD affects over 21 million people in the United States, with more than one-third of patients experiencing debilitating symptoms that current treatments cannot fully address. The Phase 3 study will evaluate the drug's efficacy, safety, and tolerability as an adjunctive therapy to antidepressants.

Neurocrine Biosciences (NBIX) has amended its collaboration agreement with Takeda regarding osavampator, a potential first-in-class AMPA positive allosteric modulator for major depressive disorder (MDD). Under the new terms, Neurocrine gains exclusive worldwide development and commercialization rights for all indications, except in Japan, which Takeda will control.

The restructured agreement establishes that each company will be responsible for development costs in their respective regions and both parties will be eligible for royalty payments. Following a successful End-of-Phase 2 meeting with the FDA, Neurocrine plans to initiate the Phase 3 program for osavampator in the first half of this year.

Neurocrine Biosciences (NBIX) has appointed Andrew Ratz, Ph.D. as Senior Vice President of Drug Development, Delivery and Device. Dr. Ratz will lead the transformation of Neurocrine's Chemistry, Manufacturing and Controls organization to support the company's expanding R&D portfolio.

Dr. Ratz joins Neurocrine following a 28-year tenure at Eli Lilly, where he contributed to developing and registering over 25 products across multiple therapeutic areas. His most recent role was Senior Vice President and Head of Drug Delivery, Device and Connected Solutions, where he led the integrated design of devices, drug-device combination products, and packaging systems. He previously served as Senior Director of Process Chemistry and Chemical Engineering and Head of Global Outsourcing for Lilly's small molecule portfolio.

Neurocrine Biosciences (NBIX) announced the publication of a supplement focused on classic congenital adrenal hyperplasia (CAH) in The Journal of Clinical Endocrinology & Metabolism. The supplement, comprising eight review articles, provides comprehensive insights into the challenges and management of classic CAH due to 21-hydroxylase deficiency.

The publication features contributions from leading endocrinologists and researchers, covering topics such as pathophysiology, clinical manifestations, treatment challenges, and advances in treatment, including CRENESSITY™ (crinecerfont), the first oral treatment that directly reduces excess adrenocorticotropic hormone and adrenal androgen production.

The supplement aims to enhance healthcare professionals' understanding of CAH management and improve patient care through evidence-based approaches. It addresses various aspects including genetics, treatment challenges in different age groups, mental health issues, and barriers to management.

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.