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Neurocrine launches CRENESSITY for adrenal hyperplasia in US.

Neurocrine launches CRENESSITY for adrenal hyperplasia in US

San Diego, USA-based Neurocrine Biosciences (Nasdaq: NBIX) today announced the launch of its Crenessity (crinecerfont) in the USA.

Neurocrine Biosciences launches Crenessity in USA

PITTSBURGH, Dec. 23, 2024 /PRNewswire/ -- PANTHERx® Rare, a leader in rare disease product patient access and support services in the United States, is pleased to announce that it was selected by Neurocrine Biosciences, Inc. for the distribution of CRENESSITY™ (crinecerfont), an oral selective corticotropin-releasing factor type 1 (CRF1) receptor antagonist indicated to improve androgen control and enable a reduced glucocorticoid dose in patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH). CRENESSITY is the first non-steroidal treatment approved for classic CAH and a first-in-class therapy that provides a novel approach to treatment for this rare disorder.CAH is a rare, autosomal recessive genetic disorder that results from deficiency of one of the enzymes needed for adrenal hormone production. The most common cause of CAH is 21-hydroxylase (21-OHD) deficiency, which accounts for approximately 95% of cases.2 21-OHD deficiency prevents the body from producing cortisol, which is essential to respond to stress and illness. In about 75% of cases, aldosterone production is also affected, which impairs the body's ability to regulate salt and water levels, and thereby blood pressure.2,3 In response to low levels of cortisol and aldosterone, the hypothalamus-pituitary-adrenal (HPA) axis is activated, leading to overproduction of androgens.2 Excess androgen production can cause a variety of symptoms, including anxiety, acne, hirsutism, atypical genital development in affected females, fertility issues, early-onset puberty, and rapid growth followed by premature completion resulting in short stature.3 These symptoms can significantly impact both the physical and mental health of those affected with CAH."We are proud to partner with Neurocrine Biosciences for the distribution of CRENESSITY

Neurocrine Biosciences, Inc. Selects Pantherx®Rare Specialty Pharmacy For Distribution Of Crenessity™ (Crinecerfont)

CRENESSITY, a First-in-Class Treatment for Classic Congenital Adrenal Hyperplasia (CAH), is now commercially available in the U.S.CAH-trained pharmacists are available 24/7 to support patients with prescriptions exclusively through PANTHERx Rare, a specialty pharmacyNeurocrine Access Support is available to provide free, comprehensive access and support information to patients, caregivers and healthcare providersSAN DIEGO, Dec. 20, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced CRENESSITY™ (crinecerfont) is now commercially available in the United States. CRENESSITY was recently approved by the U.S. Food and Drug Administration as an adjunctive treatment to glucocorticoid replacement to control androgens in adult and pediatric patients four years of age and older with classic congenital adrenal hyperplasia (CAH).CRENESSITY, a potent and selective oral corticotropin-releasing factor type 1 receptor (CRF 1 ) antagonist, is a first-in-class therapy for classic CAH that directly reduces adrenocorticotropic hormone and downstream adrenal androgen production. It is the first and only classic CAH treatment that allows people to take lower doses of glucocorticoids while maintaining or improving their androgen levels."Individuals with CAH and their families have faced ongoing challenges with managing the condition with high-dose steroids alone for the past 70 years," said Kyle W

Neurocrine Biosciences Announces Commercial Availability Of Crenessity™ (Crinecerfont) For Children And Adults With Classic Congenital Adrenal Hyperplasia

- Neurocrine Obtains Exclusive Worldwide Development and Commercialization Rights Excluding Japan and Converts to Royalty-Bearing License for Osavampator- Takeda Reacquires Rights to Osavampator in JapanSAN DIEGO, Jan. 27, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced it has amended its agreement with Takeda to develop and commercialize osavampator (NBI-1065845/TAK-653). Under the amended agreement, Neurocrine will obtain exclusive rights for all indications to develop and commercialize osavampator, a potential first-in-class AMPA positive allosteric modulator in development for patients with inadequate response to treatment of major depressive disorder (MDD) in all territories worldwide except Japan, where Takeda will reacquire exclusive rights. Under the terms of the updated agreement, each company is responsible for development costs in their respective region, and both companies are eligible to receive royalty payments."This streamlined collaboration structure allows Neurocrine to focus on bringing this important medicine to patients as quickly as possible," said Kyle Gano, Ph.D., Chief Executive Officer at Neurocrine Biosciences. "With the recent successful completion of our End-of-Phase 2 meeting with FDA for osavampator, we look forward to beginning the Phase 3 program in the first half of this year.""With its long-standing expertise developing therapies for serious psychiatric disorders, Neurocrine is the ideal partner to develop osavampator," said Sarah Sheikh, M.Sc., B.M., B.Ch, MRCP, Head, Neuroscience Therapeutic Area Unit and Head, Global Development at Takeda

Neurocrine Biosciences Announces Amendment To Strategic Collaboration With Takeda To Develop And Commercialize Osavampator (Formerly Nbi-1065845/Tak-653)

SAN DIEGO, Jan. 21, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced publication of a classic congenital adrenal hyperplasia (CAH)-focused supplement in The Journal of Clinical Endocrinology & Metabolism (JCEM), sponsored by the company. The supplement, titled "Challenges and Opportunities in the Management of Classic Congenital Adrenal Hyperplasia Due to 21-Hydroxylase Deficiency Throughout the Lifetime," contains eight review articles that provide a comprehensive look at the clinical, psychosocial, treatment-related and day-to-day challenges faced by individuals with classic CAH. JCEM is a leader in disseminating research that supports healthcare providers, patients and caregivers in advancing the understanding and management of various endocrinology conditions, such as CAH."Our understanding of the genetics, pathophysiology, and complications of CAH has exploded over the last 20 years," said Dr. Richard Auchus, M.D., Ph.D., Principal Investigator, Professor of Pharmacology and Internal Medicine, Division of Metabolism, Endocrinology, and Diabetes at the University of Michigan

Neurocrine Biosciences Announces Classic Congenital Adrenal Hyperplasia Supplement Published Today In The Journal Of Clinical Endocrinology  Metabolism

Neurocrine Biosciences has introduced a new FDA-approved therapy for classic congenital adrenal hyperplasia (CAH), a rare endocrine disorder traditionally treated with steroids that cause various side effects.

Neurocrine's First New CAH Treatment in 70 Years Gets FDA Approval

CRENESSITY, the first new treatment available in 70 years to the classic congenital adrenal hyperplasia (CAH) community, offers a paradigm-shifting treatment approach. FDA approval supported by data from the largest-ever clinical trial program in pediatric and adult patients with classic CAH. CRENESSITY is expected to be commercially available in approximately one week

Neurocrine Biosciences Announces Fda Approval Of Crenessity™ (Crinecerfont), A First-In-Class Treatment For Children And Adults With Classic Congenital Adrenal Hyperplasia

Nxera and Neurocrine entered a collaboration and licensing agreement in 2021 to develop a portfolio of novel clinical and preclinical subtype-selective muscarinic M4, M1 and dual M1/M4 receptor agonists discovered by Nxera for the treatment of schizophrenia, dementia and other neuropsychiatric disorders.

Nxera Pharma Provides Update on Neurocrine's Progress with its Partnered Muscarinic Agonist Portfolio

SAN DIEGO, Jan. 6, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) will present at the 43rd Annual J.P. Morgan Healthcare Conference at 8:15 a.m. Pacific Time on Monday January 13, 2025 in San Francisco. Kyle Gano, Chief Executive Officer, will present at the conference.The live presentation will be webcast and may be accessed on the Company's website under Investors at www.neurocrine.com

Neurocrine Biosciences To Present At The 43Rd Annual J.P. Morgan Healthcare Conference

In other recent news, Neurocrine Biosciences has launched CRENESSITY, a new treatment for congenital adrenal hyperplasia (CAH), in the United States.

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