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Neurocrine Biosciences Inc. (Nasdaq: NBIX) is a premier neuroscience-focused biopharmaceutical company based in San Diego. Established in 1992, the company is committed to developing and commercializing innovative pharmaceutical products that address unmet medical needs. Neurocrine Biosciences specializes in treatments for neurological, neuroendocrine, and neuropsychiatric disorders, impacting some of the largest pharmaceutical markets worldwide, including segments dealing with endometriosis, irritable bowel syndrome, anxiety, depression, pain, diabetes, insomnia, and other related conditions.
The company’s extensive portfolio includes FDA-approved treatments such as INGREZZA for tardive dyskinesia and chorea associated with Huntington's disease, along with investigational candidates like elagolix, opicapone, and crinecerfont. Notable late-stage clinical programs are:
- Elagolix: A hormone-releasing antagonist for women's health, particularly in treating endometriosis and uterine fibroids in collaboration with AbbVie.
- Opicapone: A catechol-O-methyltransferase (COMT) inhibitor for Parkinson's disease patients.
- Ingrezza: For treating Tourette syndrome and other movement disorders.
Recently, Neurocrine announced the initiation of a Phase 1 clinical study for NBI-1076986, an investigational M4 subtype-selective muscarinic acetylcholine receptor antagonist aimed at treating movement disorders such as Parkinson's disease tremor and dystonia. This is part of their broader muscarinic receptor-focused portfolio, which includes a variety of small molecule M1, M1/M4, and M4 agonists acquired from Nxera Pharma.
Neurocrine's robust pipeline also includes the CAHtalyst™ studies, which focus on crinecerfont for congenital adrenal hyperplasia (CAH), demonstrating significant potential in reducing glucocorticoid doses while maintaining androgen control. Their recent presentations at the American Association of Clinical Endocrinology 2024 Annual Meeting and the European Congress of Endocrinology 2024 highlight their continuous advancements.
Financially, Neurocrine Biosciences maintains a strong position with a multi-billion-dollar product in INGREZZA, and a diverse pipeline of 17 clinical development programs. Notably, the company announced the retirement of CEO Kevin Gorman, Ph.D., with Kyle Gano, Ph.D., set to succeed him in October 2024, ensuring a seamless transition and continued focus on innovative treatments.
For more comprehensive insights and updates, visit Neurocrine Biosciences and follow them on LinkedIn, X (formerly Twitter), and Facebook.
Neurocrine Biosciences (NBIX) reported strong Q3 2024 financial results, with INGREZZA net product sales reaching $613 million, representing a 26% year-over-year growth. The company raised its 2024 INGREZZA sales guidance to $2.30-$2.32 billion. Total revenues for Q3 2024 were $622.1 million, with GAAP net income of $129.8 million ($1.24 per share). The Board authorized a $300 million share repurchase plan. The company maintains a strong balance sheet with $1.87 billion in cash and marketable securities. Growth was driven by strong patient demand and improved gross-to-net dynamics across tardive dyskinesia and Huntington's disease chorea indications.
Neurocrine Biosciences (Nasdaq: NBIX) has announced its schedule for the third quarter 2024 financial results conference call and webcast. The event is set for October 30, 2024, with the press release at 4:00 a.m. PT and the conference call at 5:00 a.m. PT. Investors can access the webcast on the company'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. The company's portfolio includes FDA-approved treatments for tardive dyskinesia, Huntington's disease-associated chorea, endometriosis, and uterine fibroids. They also have multiple compounds in mid- to late-phase clinical development across their core therapeutic areas.
Neurocrine Biosciences (Nasdaq: NBIX) presented interim results from the KINECT®-HD2 study of INGREZZA® (valbenazine) for treating chorea in Huntington's disease. The study showed robust and sustained improvements in chorea through Week 104, regardless of antipsychotic use. Key findings include:
- Improved chorea as early as Week 2 (-3.4 TMC score change) with 40 mg dose
- Sustained efficacy from Week 8 (-5.7) to Week 104 (-5.2) with up to 80 mg dose
- Over 50% of participants rated symptoms as 'much improved' or 'very much improved' from Week 6 onwards
- At Week 104, 75.9% of participants self-reported improvement, with 73.6% clinician-assessed improvement
The most common side effects were falls, somnolence, and fatigue. This study is significant as it's the first to include patients taking antipsychotics in a VMAT2 inhibitor trial for Huntington's disease chorea.
Neurocrine Biosciences (Nasdaq: NBIX) will participate in the TD Cowen 4th Annual Novel Mechanisms in Neuropsychiatry Virtual Summit on September 26, 2024. Chief Business Development and Strategy Officer and CEO-elect Kyle Gano and Vice-President of Investor Relations Todd Tushla will present at 11:00 a.m. Eastern Time. The presentation will be webcast live and accessible on the company's website.
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 (Nasdaq: NBIX) announced that its ERUDITE™ Phase 2 clinical study of luvadaxistat (NBI-1065844) failed to meet its primary endpoint for improving cognitive impairment in schizophrenia patients. This second Phase 2 trial did not replicate the positive results seen in the earlier INTERACT™ study, possibly due to variability in cognitive measures and baseline characteristic imbalances. The company has decided to halt further development of luvadaxistat and will instead focus on advancing NBI-1117568 for schizophrenia and NBI-1065845 for major depressive disorder into Phase 3 clinical development. Despite the setback, Neurocrine Biosciences remains committed to developing potential treatments for unmet needs in neuropsychiatry.
Neurocrine Biosciences (NBIX) is set to participate in the 2024 Cantor Global Healthcare Conference on September 17, 2024, at 3:05 p.m. Eastern Time in New York. The company's presentation will feature Kyle Gano (Chief Business Development and Strategy Officer and CEO-elect), Matt Abernethy (Chief Financial Officer), and Todd Tushla (Vice-President of Investor Relations).
The event will be webcast live on Neurocrine's website and archived for approximately one month. Neurocrine Biosciences is a leading 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, along with a robust pipeline of compounds in mid to late-phase clinical development.
Neurocrine Biosciences (NBIX) has announced its participation in two major investor conferences this September. The company will present at the Morgan Stanley 22nd Annual Global Healthcare Conference in New York on September 4, 2024, at 3:20 p.m. ET, and the 2024 Wells Fargo Healthcare Conference in Boston on September 5, 2024, at 8:45 a.m. ET.
Key executives, including CEO Kevin Gorman, Chief Business Development and Strategy Officer Kyle Gano, and CFO Matt Abernethy, will represent the company. Both presentations will be webcast live and accessible on Neurocrine's website, with replays available for approximately one month.
Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders. Their portfolio includes FDA-approved treatments and a robust pipeline of compounds in clinical development.
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.