Associated tags: FDA, DSM-IV codes, Brain, Neurocrine Biosciences, Parkinson's disease, Patient, AbbVie, Tardive dyskinesia, SAN, Pharmaceutical industry
Locations: TURKEY, NORTH AMERICA, TD, CHICAGO, EUROPEAN UNION, DENMARK, BOSTON, MASSACHUSETTS, FLORIDA, CALIFORNIA
Disorder,
Common,
Risk,
GC,
Overweight,
Trial of the century,
Adrenocorticotropic hormone,
Hyperlipidemia,
Associate,
Deficit spending,
Hydrocortisone,
Neurocrine Biosciences,
White matter,
Food,
Oklahoma State University–Stillwater,
Cognition,
Psychology,
Testosterone,
Male,
Literature,
Brain,
DSM-IV codes,
A4,
SAN,
GCS,
CAH,
Acne,
Safety,
Glucocorticoid,
Research,
Depression,
Congenital adrenal hyperplasia,
Osteopenia,
Anxiety,
Division,
Hirsutism,
Androstenedione,
Psychiatry,
Psychosis,
Hypertension,
Metabolism,
Poster,
Pharmaceutical industry The CAHtalyst Adult study baseline data demonstrate the potential long-term consequences of current CAH treatments, with many patients in young adulthood experiencing disorders found more commonly in people decades older, including osteopenia, hypertension and hyperlipidemia.
Key Points:
- The CAHtalyst Adult study baseline data demonstrate the potential long-term consequences of current CAH treatments, with many patients in young adulthood experiencing disorders found more commonly in people decades older, including osteopenia, hypertension and hyperlipidemia.
- These new data were presented at oral presentations and poster sessions at the American Association of Clinical Endocrinology 2024 Annual Meeting in New Orleans.
- Despite supraphysiologic GC dosing, levels of adrenocorticotropic hormone, 17-hydroxyprogesterone and androstenedione (A4) were elevated at baseline, with levels of testosterone (females) and A4/testosterone (males) also elevated.
- The data from both studies supported two New Drug Applications submitted to the U.S. Food and Drug Administration in April 2024.
NBI-1117567 is an investigational, oral, muscarinic M1 preferring (M1/M4) selective agonist discovered by Nxera that may have the potential to treat symptoms of cognition in patients with neurological and neuropsychiatric conditions.
Key Points:
- NBI-1117567 is an investigational, oral, muscarinic M1 preferring (M1/M4) selective agonist discovered by Nxera that may have the potential to treat symptoms of cognition in patients with neurological and neuropsychiatric conditions.
- The clinical development milestone achieved with this compound as announced does not trigger a milestone payment from Neurocrine to Nxera under the terms of the 2021 agreement between the companies.
- Milestone payments, under the agreement, are payable upon the achievement of multiple, defined development events for each program.
- Nxera will announce the receipt of any milestone payments in accordance with TSE reporting requirements.
SAN DIEGO, May 7, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) will present at the BofA Securities 2024 Health Care Conference at 11:20 a.m. Pacific Time (2:20 p.m. Eastern Time) on Tuesday May 14, 2024 in Las Vegas.
Key Points:
- SAN DIEGO, May 7, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) will present at the BofA Securities 2024 Health Care Conference at 11:20 a.m. Pacific Time (2:20 p.m. Eastern Time) on Tuesday May 14, 2024 in Las Vegas.
- Kevin Gorman, Chief Executive Officer, Matt Abernethy, Chief Financial Officer, and Kyle Gano, Chief Business Development and Strategy Officer, will present at the conference.
- The live presentation will be webcast and may be accessed on Neurocrine Biosciences' website under Investors at www.neurocrine.com .
- A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.
Safety,
Patient,
Neurocrine Biosciences,
CAH,
Abstract,
Hydrocortisone,
Congenital adrenal hyperplasia,
ECE,
Adrenal crisis,
Treatment,
Adrenocorticotropic hormone,
Capsule,
SAN,
Incidence,
Pharmaceutical industry SAN DIEGO, May 7, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that it will present key information from its neuroendocrinology pipeline, including baseline characteristics data from its CAHtalyst™ Program of crinecerfont in congenital adrenal hyperplasia (CAH), as well as data from its modified-release hydrocortisone studies in primary adrenal insufficiency and CAH, at the European Congress of Endocrinology 2024 meeting in Sweden, May 11–14.
Key Points:
- SAN DIEGO, May 7, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that it will present key information from its neuroendocrinology pipeline, including baseline characteristics data from its CAHtalyst™ Program of crinecerfont in congenital adrenal hyperplasia (CAH), as well as data from its modified-release hydrocortisone studies in primary adrenal insufficiency and CAH, at the European Congress of Endocrinology 2024 meeting in Sweden, May 11–14.
- Neurocrine Biosciences will be presenting several abstracts and posters at ECE 2024, including:
Baseline Characteristics of Children and Adolescents with Classic Congenital Adrenal Hyperplasia Enrolled in CAHtalyst Pediatric, a Phase 3 Study of Crinecerfont, a Corticotropin-Releasing Factor Type 1 Receptor Antagonist
Baseline Characteristics of Adults with Classic Congenital Adrenal Hyperplasia Enrolled in CAHtalyst Adult, a Phase 3 Study of Crinecerfont, a Corticotropin-Releasing Factor Type 1 Receptor Antagonist
CHAMPAIN study: Initial Results from a Phase II Study of Efficacy, Safety and Tolerability of Modified-Release Hydrocortisones: Chronocort® (Efmody®) versus Plenadren, in Primary Adrenal Insufficiency,
Biochemical Control with Dose Reduction in Chronic Glucocorticoid Therapy over 4 Years: A Phase III Extension Study of Chronocort (Efmody®) in the Treatment of Congenital Adrenal Hyperplasia (CAH)
Incidence of Adrenal Crisis in Congenital Adrena Hyperplasia (CAH) Patients During a Prospective Monitored Long-Term study of Modified-Release Hydrocortisone (MRHC) Capsules, (Efmody)
Frustration,
Tardive dyskinesia,
Neurocrine Biosciences,
Risk,
Mental Health Awareness Month,
Neurocrine,
Bipolar disorder,
DSM-IV codes,
Somatic symptom disorder,
Schizophrenia,
Policy,
Mental health,
Patient,
Movement disorder,
Diagnosis,
MBC,
Mental,
SAN,
Nursing 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.
Key Points:
- 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 Awareness Week increases dialogue around the physical, social and emotional consequences the uncontrollable movements of TD can have on individuals who are trying to manage their mental health," said Josie Cooper, Executive Director of the Movement Disorders Policy Coalition.
- "We are committed to partnering with all stakeholders during TD Awareness Week and beyond to advocate for routine screenings for patients at risk for TD."
- To learn more about TD, living with TD and how to treat TD, visit TalkAboutTD.com .
Weill Cornell Medical Center,
Hyperplasia,
Weill Cornell Medicine,
Patient,
Neurocrine Biosciences,
Clinical Pediatrics,
CAH,
Safety,
GC,
Androstenedione,
Food,
Male,
Congenital adrenal hyperplasia,
Observation,
Obesity,
Disease,
D.O,
Hirsutism,
Diagnosis,
Poster,
Associate,
Adrenocorticotropic hormone,
Natural history,
SAN,
Pharmaceutical industry SAN DIEGO, May 3, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today presented the CAHtalyst™ Pediatric Phase 3 clinical study baseline characteristics data for children and adolescents with congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency enrolled in the study, along with CAHtalog™ Registry data assessing glucocorticoid treatment patterns in pediatric and adult patients with CAH.
Key Points:
- SAN DIEGO, May 3, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today presented the CAHtalyst™ Pediatric Phase 3 clinical study baseline characteristics data for children and adolescents with congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency enrolled in the study, along with CAHtalog™ Registry data assessing glucocorticoid treatment patterns in pediatric and adult patients with CAH.
- These new data were presented at the Pediatric Endocrine Society 2024 Annual Meeting in Chicago.
- Baseline characteristics of the subjects who enrolled in the CAHtalyst Pediatric Phase 3 study were presented (Poster# 56).
- Neurocrine Biosciences also presented glucocorticoid treatment patterns from a recent cohort of pediatric and adult patients participating in the CAHtalog Registry (Poster# 51).
FDA,
Capsule,
Dysphagia,
Neurocrine Biosciences,
Huntington's disease,
Food,
Tardive dyskinesia,
HD,
Patient,
Chemistry,
Caregiver,
VMAT2,
Chorea,
SAN,
Pharmaceutical industry SAN DIEGO, April 30, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration has approved INGREZZA® SPRINKLE (valbenazine) capsules, a new oral granules formulation of INGREZZA® (valbenazine) capsules prescribed for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease.1 INGREZZA SPRINKLE provides an alternative administration option for those who experience dysphagia or have difficulty swallowing.
Key Points:
- SAN DIEGO, April 30, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration has approved INGREZZA® SPRINKLE (valbenazine) capsules, a new oral granules formulation of INGREZZA® (valbenazine) capsules prescribed for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease.1 INGREZZA SPRINKLE provides an alternative administration option for those who experience dysphagia or have difficulty swallowing.
- "We developed INGREZZA SPRINKLE to make administration easier for patients who have difficulty swallowing or prefer not to take a capsule," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences.
- "We are pleased to offer the proven efficacy of INGREZZA in reducing uncontrollable movements in a new formulation."
- ‡,†
The U.S. Food and Drug Administration (FDA) approval was based on chemistry, manufacturing, and controls information and data demonstrating the bioequivalence and tolerability of INGREZZA SPRINKLE compared to INGREZZA capsules.
SAN DIEGO, April 16, 2024 (GLOBE NEWSWIRE) -- Sentia Medical Sciences Inc. today announced that they have further extended a research collaboration with Neurocrine Biosciences, Inc. (Nasdaq: NBIX) aimed at discovering novel, long-acting corticotropin-releasing factor (CRF) receptor antagonist peptide therapeutics.
Key Points:
- SAN DIEGO, April 16, 2024 (GLOBE NEWSWIRE) -- Sentia Medical Sciences Inc. today announced that they have further extended a research collaboration with Neurocrine Biosciences, Inc. (Nasdaq: NBIX) aimed at discovering novel, long-acting corticotropin-releasing factor (CRF) receptor antagonist peptide therapeutics.
- Under the terms of the research collaboration extension, Sentia and Neurocrine will continue to work together to discover novel peptide antagonists targeting CRF and advance them to development candidate stage, after which Neurocrine would be solely responsible for all further development, manufacturing, regulatory and commercial activities.
- As part of the collaboration, Sentia will continue to receive committed research funding from Neurocrine to support discovery efforts.
- “We are delighted to further extend this important collaboration focused on the discovery and development of novel peptide therapeutics to address HPA-driven diseases and other potential indications with disrupted CRF physiology” said Dominic P. Behan, Ph.D., D.Sc., Chief Executive Officer of Sentia Medical Sciences.
long-term) dosing in future clinical trials.
Key Points:
- long-term) dosing in future clinical trials.
- The achievement of this important safety development milestone triggers a $15 million payment to Nxera from Neurocrine.
- These candidates have potential to address a range of neurological and neuropsychiatric conditions and include:
Matt Barnes, EVP, President of Nxera Pharma UK and Head of R&D, commented: “We are delighted that NBI-1117568 has successfully achieved this important safety development milestone.
- These results will support the safe, long-term use of this novel clinical candidate, which is consistent with a desired product profile for schizophrenia and other neurological diseases where patients often need therapy over many years.
Retrieved on:
Wednesday, April 24, 2024
Glucocorticoid,
Neurocrine Biosciences,
CAH,
Adrenal insufficiency,
Neurocrine,
Research,
Parent,
Life,
Congenital adrenal hyperplasia,
CRF1,
Patient,
Caregiver,
SAN,
Pharmaceutical industry provides a platform for the congenital adrenal hyperplasia (CAH) community to find educational information, share experiences and learn about current research.
Key Points:
- provides a platform for the congenital adrenal hyperplasia (CAH) community to find educational information, share experiences and learn about current research.
- SAN DIEGO, April 24, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the launch of WHAT THE C@H?!
- , an educational initiative that aims to close the gap in the need for helpful information about congenital adrenal hyperplasia (CAH) and acknowledges the frustrations and challenges experienced by the community in managing the condition.
- "We hope this educational initiative, which was informed by insights from the community, is helpful to those navigating and managing this difficult condition."
