Neurocrine Biosciences

Neurocrine Biosciences, Inc. is a neuroscience-focused, biopharmaceutical company. It discovers, develops and intends to commercialize drugs for the treatment of neurological and endocrine related diseases and disorders. The firm's product includes INGREZZA. The company was founded by Kevin C. Gorman and Wylie W. Vale in January 1992 and is headquartered in San Diego, CA.

Earnings data Q1 2021

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Neurocrine Biosciences reports strong Q4 performance and eyes growth

Neurocrine Biosciences delivered strong performance in Q4 2022, with robust INGREZZA sales and a positive outlook for 2023, supported by significant investments in SG&A and R&D.
The company's focus on expanding into long-term care, advancing pipeline assets, and collaborations for innovative treatments positions it well for growth and addressing unmet needs.
While facing challenges in managing increased spending and market dynamics, Neurocrine remains optimistic about opportunities in expanding treatment reach, market penetration, and advancing clinical programs.

Neurocrine Biosciences reports strong Q1 performance and eyes international expansion

Neurocrine Biosciences had a strong Q1 performance with record sales, upcoming milestones, and disciplined expense management.
The company faces challenges in certain therapeutic categories but is optimistic about addressing unmet needs and expanding internationally.
Opportunities lie in innovative science, market positioning, and portfolio expansion, positioning Neurocrine for future growth.
Addressing concerns around drug interactions, dosing strategies, and trial risks will be crucial for maintaining clinical success and patient safety.

Neurocrine Biosciences excels in Q2, eyes growth opportunities ahead

Neurocrine Biosciences shows strong financial performance and growth prospects.
Focus on INGREZZA's persistency and pipeline advancements drives optimism.
Challenges include market dynamics and clinical trial complexities.
Opportunities lie in new indications, long-term care expansion, and telemedicine.

Neurocrine Biosciences excels in Q3, eyes growth in LTC segment

Neurocrine Biosciences delivered a strong Q3 performance with robust sales, positive regulatory developments, and promising pipeline advancements.
The company's focus on expanding indications, exploring combination therapies, and addressing market opportunities positions it for future growth.
While facing challenges in market evaluation and competition, Neurocrine Biosciences has opportunities to leverage its strengths and drive innovation.
Investors can look forward to upcoming events like the Analyst Day and R&D Day for deeper insights into the company's strategic direction and growth potential.

Neurocrine Biosciences excels in 2023, eyes Crinecerfont launch success

Neurocrine Biosciences had a strong 2023 with notable achievements in sales growth and pipeline advancements. While facing challenges in market dynamics and pricing negotiations, the company is well-positioned to leverage opportunities in upcoming launches and strategic growth initiatives.

Neurocrine Biosciences excels in Q1 with strong sales and pipeline advancements

Neurocrine Biosciences delivered a strong performance in Q1 2024, driven by robust INGREZZA sales, promising Phase II results for NBI-845, and advancements in Crinecerfont development.
The company's strengths lie in its diverse pipeline, financial stability, and strategic focus on chronic therapy and tolerability, positioning it for future growth and innovation.
While facing challenges in dosing optimization and revenue management, Neurocrine has opportunities to leverage its pipeline, explore new treatments, and differentiate its offerings in the market.

Neurocrine Biosciences excels in Q3, poised for growth ahead

Neurocrine Biosciences showcased robust performance in Q3, with strong INGREZZA sales and pipeline success, positioning for future growth.
The company's strengths lie in its expanded sales team, leadership quality, and commitment to innovation and value creation for shareholders.
Challenges include potential payer reimbursement issues, FDA interactions for Phase III strategy, and competitive pressures in the market.
Opportunities abound with upcoming regulatory approvals, pipeline advancements, and targeted commercial strategies for new product launches.

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Neurocrine Biosciences, Inc. is a neuroscience-focused, biopharmaceutical company, which engages in the research, development, and commercialization of pharmaceuticals for the treatment of neurological, neuroendocrine, and neuropsychiatric disorders. The company was founded by Kevin C. Gorman and Wylie W. Vale in January 1992 and is headquartered in San Diego, CA.

Ingrezza Sprinkle, granules, has been recently granted with the FDA approval. Supporting $2.1-2.2 billion in 2024 sales for the whole Ingrezza franchise guided by Neurocrine's management. Neurocrine Biosciences, Inc. has two new drug applications for Crinecerfont accepted by the FDA with a priority review, potentially leading to regulatory approval by the end of 2024. Positive results from Crinecerfont trials show efficacy in controlling androgen hormones in patients with congenital adrenal hyperplasia, supporting potential regulatory approval.

Neurocrine's Pipeline, Including Crinecerfont's Priority Review, Drives Long-Term Growth

PDUFA Target Action Dates in Late December 2024 Highly Selective CRF1 Antagonist is the Potential First New Treatment for CAH in 70 Years SAN DIEGO , July 1, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration (FDA) has accepted its two New Drug Applications (NDA) with Priority Review designations for crinecerfont in the treatment of children, adolescents and adults with classic congenital adrenal hyperplasia (CAH). If approved, crinecerfont would be the first new treatment option for CAH in 70 years and a first-in-class therapy, with a novel approach for the treatment of this rare and serious endocrine disorder.

Neurocrine Biosciences Announces U.S. FDA Accepts New Drug Applications and Grants Priority Review for Crinecerfont for Pediatric and Adult Patients with CAH

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SAN DIEGO , June 3, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) and Diurnal Ltd., a Neurocrine Biosciences company, presented information from its neuroendocrinology pipeline at the Endocrine Society Annual Meeting, ENDO 2024, including primary data just published in The New England Journal of Medicine from its CAHtalyst™ Phase 3 registrational studies of crinecerfont in pediatric and adult patients with congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency.

Neurocrine Biosciences Presented CAHtalyst™ Phase 3 Pediatric and Adult Studies, CAHtalog™ Registry and Disease- and Glucocorticoid-Related Comorbidities Data in CAH at ENDO 2024

-          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 Participants     -          Favorable Trends in Endpoints Reflecting Supraphysiologic Glucocorticoid Dosing and Androgen Excess     -          Crinecerfont was Generally Well Tolerated SAN DIEGO , June 3, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that the primary study results from its CAHtalyst™ Pediatric Phase 3 study investigating crinecerfont for the treatment of congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency have been published in The New England Journal of Medicine online edition and will appear in a future print issue of the journal. The CAHtalyst Pediatric Phase 3 study met the primary and key secondary endpoints related to androgen reduction (during an initial glucocorticoid-stable period) and glucocorticoid (GC) dose reduction while maintaining androgen control.

Neurocrine Biosciences Announces Publication of Primary CAHtalyst™ Pediatric Phase 3 Study Results of Crinecerfont for the Treatment of CAH in The New England Journal of Medicine

-          CAHtalyst™ Adult Phase 3 Study Met Primary and Important Key Secondary Endpoints, with Crinecerfont Treatment Decreasing Androstenedione Levels and Enabling Glucocorticoid Dose Reduction While Maintaining Androstenedione Control        -          62.7% of Crinecerfont Participants Achieved a Physiologic Glucocorticoid Dose while Maintaining Androstenedione Control versus 17.5% of Placebo Participants     -          Favorable Trends in Endpoints Reflecting Consequences of Supraphysiologic Glucocorticoid Dosing     -          Crinecerfont was Generally Well Tolerated SAN DIEGO , June 3, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that the primary study results from its CAHtalyst™ Phase 3 study investigating crinecerfont for the treatment of adults ages 18 and older with congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency have been published in The New England Journal of Medicine online edition and will appear in a future print issue of the journal. The study met the primary and important key secondary endpoints related to androgen reduction (during an initial glucocorticoid-stable period) and glucocorticoid (GC) dose reduction while maintaining androgen control.

Neurocrine Biosciences Announces Publication of Primary CAHtalyst™ Adult Phase 3 Study Results of Crinecerfont for the Treatment of CAH in The New England Journal of Medicine

Jefferies Global Healthcare Conference on June 5 in New York Goldman Sachs 45th Annual Global Healthcare Conference on June 13 in Miami SAN DIEGO, May 29, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) will participate at two upcoming investor conferences in June. Kevin Gorman, Chief Executive Officer, Kyle Gano, Chief Business Development and Strategy Officer, and Matt Abernethy, Chief Financial Officer will present at the Jefferies Global Healthcare Conference at 2:30 p.m.

Neurocrine Biosciences to Participate at Investor Conferences in June

Neurocrine Biosciences CEO Kevin Gorman will retire on Oct. 11 after three decades with the company that he founded and will be succeeded by insider Kyle Gano.

Neurocrine founder-CEO Gorman to retire in October

Board of Directors appoints Kyle Gano, Ph.D., Chief Business Development and Strategy Officer, as CEO-elect, effective October 11, 2024 Kevin Gorman, Ph.D.

Neurocrine Biosciences Announces CEO Succession Plan

New CAHtalyst™ Pediatric and CAHtalyst™ Adult Phase 3 Clinical Study Data in Congenital Adrenal Hyperplasia CAHtalog™ Registry Data Highlighting Impact of Supraphysiologic Glucocorticoid Dosing Phase 2 (CHAMPAIN) Study Data for MRHC vs. Plenadren in Primary Adrenal Insufficiency Long-Term Study Data for MRHC in Adults with CAH SAN DIEGO , May 28, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that it will present key information from its neuroendocrinology pipeline, including new Phase 3 clinical study data from its CAHtalyst™ registrational studies of crinecerfont in pediatric and adult patients with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency and data from its modified-release hydrocortisone (MRHC) studies in primary adrenal insufficiency and CAH.

Neurocrine Biosciences to Present New Phase 3 CAHtalyst™ Data in Adult and Pediatric Patients with CAH and Study Data for Modified-Release Hydrocortisone in Primary Adrenal Insufficiency and CAH at ENDO 2024

SAN DIEGO , May 21, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the publication of data from a post hoc analysis of the Phase 3 KINECT®-4 study of INGREZZA® (valbenazine) capsules in the Journal of Clinical Psychopharmacology . The analysis assessed long-term outcomes relevant to the real-world management of tardive dyskinesia (TD) and demonstrated that nearly all study participants met the threshold for clinically meaningful improvements in TD symptom severity by Week 48.

Neurocrine Biosciences Announces Publication of Phase 3 KINECT®-4 Post Hoc Analysis Demonstrating Clinically Meaningful and Sustained Improvement in Tardive Dyskinesia With Long-Term Use of INGREZZA® (valbenazine) Capsules

- 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     SAN DIEGO , May 14, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) and Diurnal Ltd., a Neurocrine Biosciences company, presented baseline data from the CAHtalyst™ Phase 3 studies of crinecerfont in adult and pediatric patients with congenital adrenal hyperplasia (CAH), and modified-release hydrocortisone (Chronocort®) data for a Phase 2 clinical study (CHAMPAIN) in participants with primary adrenal insufficiency and in a Phase 3 extension study in CAH.

Neurocrine Biosciences Presented Baseline Data from the CAHtalyst™ Program in CAH and Study Data for Modified-Release Hydrocortisone in Primary Adrenal Insufficiency and CAH at ECE 2024

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 with congenital adrenal hyperplasia (CAH) enrolled in the study, as well as data from a comprehensive literature review assessing the impact of supraphysiologic glucocorticoid (GC) doses on psychiatric disorders and cognition in patients with CAH. 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.

Neurocrine Biosciences Presents CAHtalyst™ Adult Study Baseline Characteristics and Data on Impact of Supraphysiologic Glucocorticoid Therapy at AACE 2024

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 Biosciences.

Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating Effects of NBI-1076986 in Healthy Adults

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 .

Nxera Pharma's partner Neurocrine Biosciences Initiates Phase 1 Clinical Study Evaluating Effects of NBI-1117567 in Healthy Adults

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 Announces Initiation of Phase 1 Clinical Study Evaluating Effects of NBI-1117567 in Healthy Adults

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.

Neurocrine Biosciences to Present at the BofA Securities 2024 Health Care Conference

CAHtalyst™ Pediatric and CAHtalyst™ Adult Baseline Characteristics Data in Congenital Adrenal Hyperplasia Phase 2 (CHAMPAIN) Clinical Study Data for Modified-Release Hydrocortisone (Chronocort®/Efmody®) in Adrenal Insufficiency Phase 3 Extension Study Data for Modified-Release Hydrocortisone in Congenital Adrenal Hyperplasia 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 May 13; 5:30–6:30pm (Poster# P225) 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 May 14; 1:40–3:10pm (Poster# P423) 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, May 12; 2:00–2:40pm (Rapid Communication #RC3.4) 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) May 12; 2:00–2:40pm (Rapid Communication #RC3.1) Incidence of Adrenal Crisis in Congenital Adrena Hyperplasia (CAH) Patients During a Prospective Monitored Long-Term study of Modified-Release Hydrocortisone (MRHC) Capsules, (Efmody) May 12; 4:20–6:00pm (Poster #P215) Morning Cortisol Levels in Patients with Established Primary Adrenal Insufficiency May 13; 5:30– 6:30pm (Poster #P13) About Congenital Adrenal Hyperplasia Congenital adrenal hyperplasia (CAH) is a rare genetic condition that results in an enzyme deficiency that alters the production of adrenal hormones which are essential for life.

Neurocrine Biosciences to Present Phase 3 Baseline Characteristics Data from the CAHtalyst™ Program of Crinecerfont in CAH, and Data for Modified-Release Hydrocortisone in Primary Adrenal Insufficiency and CAH Studies at ECE 2024

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, involuntary movement disorder associated with the use of antipsychotic medication that may be necessary to treat individuals living with mental illness, such as bipolar disorder, major depressive disorder, schizophrenia and schizoaffective disorder.1,5-7 For seven consecutive years, TD Awareness Week – which occurs each year during Mental Health Awareness Month – has brought together the mental health advocacy community and states across the country to recognize the approximately 600,000 people in the U.S. living with TD.1,2 This year, Neurocrine is joining participants of TD Awareness Week to conduct initiatives nationwide to decrease stigma, improve recognition and increase routine screenings, diagnosis and awareness of appropriate treatment of TD.

Neurocrine Biosciences Supports Tardive Dyskinesia Awareness Week by Advocating for Routine Screening and Monitoring

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CAHtalyst™ Pediatric Study Baseline Characteristics Data Highlight Need for Novel Treatments in Children and Adolescents with Congenital Adrenal Hyperplasia (CAH) CAHtalog™ Registry Data of Glucocorticoid Treatment Patterns in Pediatric and Adult Patients Illustrates the Challenges of Long-Term CAH Management 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 data demonstrate the limitations of current CAH treatment approaches in pediatric patients, comorbidities associated with the condition and/or current treatment, including obesity, advanced bone age, and early puberty, and the difficulty in managing the disease effectively as CAH patients age into adults.

Neurocrine Biosciences Presented CAHtalyst™ Pediatric Study Baseline Characteristics and CAHtalog™ Registry Data at PES 2024

Neurocrine Biosciences, Inc. (NASDAQ:NBIX ) Q1 2024 Earnings Conference Call May 1, 2024 8:00 AM ET Company Participants Todd Tushla - VP, IR Kevin Gorman - CEO Matt Abernethy - CFO Eric Benevich - Chief Commercial Officer Eiry Roberts - Chief Medical Officer Kyle Gano - Chief Business Development & Strategy Officer Conference Call Participants Tazeen Ahmad - Bank of America Phil Nadeau - TD Cowen Paul Matteis - Stifel Chris Shibutani - Goldman Sachs Akash Tewari - Jefferies Jay Olson - Oppenheimer Mohit Bansal - Wells Fargo Brian Skorney - Baird Brian Abrahams - RBC Capital Markets Carter Gould - Barclays Anupam Rama - JPMorgan Marc Goodman - Leerink Myles Minter - William Blair Jeff Hung - Morgan Stanley Laura Chico - Wedbush Securities Danielle Brill Bongero - Raymond James Yatin Suneja - Guggenheim Sumant Kulkarni - Canaccord Evan Seigerman - BMO David Hoang - Citigroup Ami Fadia - Needham David Amsellem - Piper Sandler Operator Good day everyone and welcome to Neurocrine Biosciences' reports First Quarter Results. At this time, all participants are in a listen-only mode.

Neurocrine Biosciences, Inc. (NBIX) Q1 2024 Earnings Call Transcript

Although the revenue and EPS for Neurocrine (NBIX) give a sense of how its business performed in the quarter ended March 2024, it might be worth considering how some key metrics compare with Wall Street estimates and the year-ago numbers.

Neurocrine (NBIX) Reports Q1 Earnings: What Key Metrics Have to Say

Neurocrine Biosciences (NBIX) came out with quarterly earnings of $0.42 per share, missing the Zacks Consensus Estimate of $1.04 per share. This compares to loss of $0.79 per share a year ago.

Neurocrine Biosciences (NBIX) Q1 Earnings Miss Estimates

Neurocrine stock jumped early Wednesday after the company's biggest moneymaker, Ingrezza, topped first-quarter sales forecasts.

News for Neurocrine Biosciences Stock (NBIX)