- Favorable Trends in Endpoints Reflecting Supraphysiologic Glucocorticoid Dosing and Androgen Excess - Crinecerfont was Generally Well Tolerated - CAHtalyst™ Pediatric Study Met Primary and Key Secondary Endpoints, with Crinecerfont Treatment Decreasing Androstenedione Levels and Enabling Glucocorticoid Dose Reduction While Maintaining Androstenedione Control - 30% of Crinecerfont Participants Achieved a Physiologic Glucocorticoid Dose at Week 28 while Maintaining Androgen Control versus 0% of Placebo Part ...

Crinecerfont is an investigational, oral, selective corticotropin-releasing factor type 1 receptor (CRF1) antagonist being developed to reduce and control excess adrenocorticotropic hormone (ACTH) and adrenal androgens through a GC-independent mechanism for the treatment of CAH. "The CAHtalyst Adult Phase 3 study demonstrated the ability of crinecerfont to substantially reduce glucocorticoid doses to more physiologic levels while maintaining or improving androgen control," said Eiry W. Roberts, M.D., Chief ...

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis* and uterine fibroids* ...

Core Points - Neurocrine Biosciences announced the retirement of CEO Kevin Gorman, effective October 11, 2024, with Kyle Gano appointed as CEO-elect [1][2] - Under Dr. Gorman's leadership since 2008, Neurocrine has developed a strong financial position and a mature pipeline, including the successful commercial product INGREZZA® [2][3] - The company has submitted two New Drug Applications for crinecerfont to the FDA for treating classic congenital adrenal hyperplasia [2] - Neurocrine currently has 17 clinical development programs focusing on neurology, neuroendocrinology, and neuropsychology [2] Company Overview - Neurocrine Biosciences is a neuroscience-focused biopharmaceutical company dedicated to developing treatments for under-addressed neurological, neuroendocrine, and neuropsychiatric disorders [6] - The company has a diverse portfolio that includes FDA-approved treatments for tardive dyskinesia and chorea associated with Huntington's disease, as well as a robust pipeline in mid- to late-phase clinical development [6] - INGREZZA is the only once-daily selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved for treating adults with tardive dyskinesia and chorea associated with Huntington's disease [7][8] Leadership Transition - Dr. Gorman expressed confidence in Dr. Gano's ability to lead the company into its next growth phase, highlighting their long-standing collaboration [3] - Dr. Gano has over 23 years of experience at Neurocrine, with a focus on business and corporate development, and has played a key role in the company's strategic collaborations and FDA-approved medicines [4][5] - The Board of Directors is optimistic about Dr. Gano's leadership and vision for the future of Neurocrine [3]

- CAHtalyst™ Phase 3 Baseline Characteristics Highlight Limitations of Current CAH Treatment Paradigm in Children, Adolescents and Adults - Phase 2 Study for Modified-Release Hydrocortisone in Adults with Adrenal Insufficiency Demonstrated Participants Achieved Physiological Morning Cortisol Levels after 4 Weeks - Phase 3 Extension Study Data for Modified-Release Hydrocortisone in Adults with CAH Demonstrated Reduction in Median Daily Hydrocortisone Dose and an Increase in Responders at Levels ≤ 25 mg/day S ...

CAHtalyst™ Study Baseline Characteristics Highlight the Need for New Treatment Options to Reduce Adrenal Androgens and Supraphysiologic Glucocorticoid Dosing in CAH Adult Patients Comprehensive Literature Review Identified Potential Psychological and Cognitive Impact of High Glucocorticoid Doses in CAH Patients SAN DIEGO, May 9, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that it will present CAHtalyst™ Adult Phase 3 clinical study baseline characteristics for adults w ...

SAN DIEGO, May 9, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of its Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1076986 in healthy adult participants. NBI-1076986 is an investigational, oral, M4 subtype-selective muscarinic acetylcholine receptor antagonist for the potential treatment of movement disorders that was discovered and developed by Neurocrine ...

Tokyo, Japan and Cambridge, UK, 9 May 2024 – Nxera Pharma ("the Company" or "Nxera"; TSE: 4565) notes that its partner Neurocrine Biosciences Inc. (("Neurocrine", NASDAQ:NBIX), a leading neuroscience-focused biopharmaceutical company, announced that it has initiated its Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1117567 in healthy adult participants – see Neurocrine press announcement here. NBI-1117567 is ...

SAN DIEGO, May 8, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced the initiation of its Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1117567 in healthy adult participants. NBI-1117567 is an investigational, oral, M1/M4 (M1 preferring) selective muscarinic agonist for the potential treatment of neurological and neuropsychiatric conditions. "Neurocrine Biosciences has the lar ...

Approximately 600,000 people in the United States live with tardive dyskinesia (TD), and about 65% have not yet been diagnosed1-3 The diagnosis rate can be improved by increasing routine TD screenings in people treated with antipsychotic medication4   SAN DIEGO, May 6, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today renewed its commitment to increasing awareness and advancing care for people living with TD during Tardive Dyskinesia Awareness Week, May 5-11. TD is a persistent, invol ...