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.

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Earnings data Q4 2024

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.

Prescription Drug User Fee Act (PDUFA) Target Action Date Set for April 30, 2024 SAN DIEGO , Sept. 14, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc.  (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for INGREZZA® (valbenazine) oral granules, a new sprinkle formulation of INGREZZA® (valbenazine) capsules for oral administration.

Neurocrine Biosciences Announces U.S. FDA Accepts New Drug Application for INGREZZA® (valbenazine) Oral Granules Sprinkle Formulation

Neurocrine said Tuesday its experimental drug could help lower steroid use for patients with a rare, adrenal disease. NBIX stock surged.

Can Neurocrine Erase Its Recent Setbacks With This Jump To An Eight-Month High?

CAHtalyst ™ Met Primary Endpoint Demonstrating a Statistically Significant Decrease from Baseline Daily Glucocorticoid Dose with Androgen Control Key Secondary Endpoint Achieved Statistically Significant Decrease in Androstenedione at Week 4 versus Placebo  Key Secondary Endpoint Demonstrated a Statistically Significant Number of Patients on Crinecerfont Achieved a Reduction to a Physiologic Glucocorticoid Dose versus Placebo Crinecerfont Was Generally Well-Tolerated  SAN DIEGO , Sept. 12, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced positive top-line data from the Phase 3 CAHtalyst™ Adult Study evaluating the efficacy, safety, and tolerability of crinecerfont in adults with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency (21-OHD).

Neurocrine Biosciences Announces Positive Top-Line Data from Phase 3 Study of Crinecerfont in Adults for the Treatment of Congenital Adrenal Hyperplasia (CAH)

Tokyo, Japan and Cambridge, UK, 12 September 2023 – Sosei Group Corporation (“the Company”; TSE: 4565), has been notified by its partner Neurocrine Biosciences Inc. (“Neurocrine”; Nasdaq: NBIX), a leading neuroscience-focused biopharmaceutical company, that it has initiated its Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1117570 in healthy adult participants. NBI-1117570 is an investigational, oral, muscarinic M1/M4 selective dual agonist that may have the potential to treat neurological and neuropsychiatric conditions and was developed utilising Sosei Heptares' structure-based drug design platform.

Sosei Heptares' partner Neurocrine Biosciences Initiates Phase 1 Clinical Study Evaluating Effects of NBI-1117570 in Healthy Adults

SAN DIEGO , Sept. 11, 2023 /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-1117570 in healthy adult participants.

Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating Effects of NBI-1117570 in Healthy Adults

2023 Wells Fargo Healthcare Conference on September 7 in Boston Morgan Stanley 21st Annual Global Healthcare Conference on September 12 in New York SAN DIEGO , Aug. 31, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) will participate at two upcoming investor conferences in September. Kyle Gano, Chief Business Development and Strategy Officer, and Todd Tushla, Vice President of Investor Relations, will present at the 2023 Wells Fargo Healthcare Conference at 3:45 p.m.

Neurocrine Biosciences to Present at Upcoming Investor Conferences in September

SAN DIEGO , Aug. 29, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today presented findings from a data analysis of KINECT®-4 demonstrating a comparable pattern of improvement over time of clinician-rated tardive dyskinesia (TD) severity and awareness/distress as measured by the Abnormal Involuntary Movement Scale (AIMS) and patient-reported TD impact as measured by the Trajectories of Tardive Dyskinesia Impact Scale (TDIS). The data (Poster #657) was presented at the MDS International Congress of Parkinson's Disease and Movement Disorders® in Copenhagen, Denmark.

Neurocrine Biosciences Presents Data at MDS International Congress of Parkinson's Disease and Movement Disorders® Demonstrating Comparable Improvement Over Time in Tardive Dyskinesia Severity and Impact Following Treatment With INGREZZA® (valbenazine) Cap

Data Presented at the 2023 MDS International Congress of Parkinson's Disease and Movement Disorders® SAN DIEGO , Aug. 28, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new data on now FDA-approved INGREZZA® (valbenazine) capsules for the treatment of adults with chorea associated with Huntington's disease (HD), including exploratory results from the Phase 3 KINECT®-HD study, which showed consistently greater improvements in HD chorea with INGREZZA versus placebo from Week 2 to Week 12. These data will be presented at the MDS International Congress of Parkinson's Disease and Movement Disorders® August 27-31 in Copenhagen, Denmark.

Neurocrine Biosciences Presents New INGREZZA® (valbenazine) Capsules Data Demonstrating Early and Sustained Improvements in Chorea Associated With Huntington's Disease

Neurocrine Biosciences needs a clinical win after years of disappointing results and stagnant stock performance. The upcoming Phase III data on crinecerfont, a treatment for congenital adrenal hyperplasia, is highly significant to sentiment, and earlier data read-outs do offer some reasons for bullishness. I believe Neurocrine shares should trade in the mid-$120s; success with crinecerfont can drive a fair value in the $130's, though failure would drive fair value to the $105 range.

Neurocrine Needs A Meaningful Clinical Win To Break Out, And Crinecerfont Could Do It

Neurocrine Biosciences Inc. NBIX, +2.55% said Friday that the U.S. Food and Drug Administration has approved Ingrezza for treatment of an involuntary movement disorder linked with Huntington's disease, prompting analysts at Oppenheimer to boost their price target on the shares. “Ingrezza could become a pipeline-in-a-product,” based on additional indications beyond the movement disorder, called chorea, the Oppenheimer analysts wrote in a note Sunday, raising their price target on the stock to $154, from $150 previously.

Neurocrine Biosciences price target raised at Oppenheimer after FDA approves movement disorder treatment

SAN DIEGO , Aug. 18, 2023 /PRNewswire/ --  Neurocrine Biosciences, Inc .  (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration (FDA) has approved INGREZZA® (valbenazine) capsules for the treatment of adults with chorea associated with Huntington's disease (HD).1 INGREZZA is the only selective vesicular monoamine transporter 2 (VMAT2) inhibitor that offers an effective starting dosage that can be adjusted by a patient's healthcare provider based on response and tolerability, with no complex titration.1 Only INGREZZA offers simple dosing that is always one capsule, once daily.1 Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9147451-neurocrine-biosciences-fda-approval-ingrezza/  The FDA approval is supported by data from two clinical studies conducted in collaboration with the Huntington Study Group (HSG), including the KINECT®-HD Phase 3 study and the ongoing KINECT®-HD2 open-label extension trial.1,2 KINECT-HD, a randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of INGREZZA, met its primary endpoint of least squares mean (LSM) change in chorea severity using the Total Maximal Chorea (TMC) score of the Unified Huntington's Disease Rating Scale (UHDRS) from screening period baseline to maintenance period (average of Weeks 10 and 12), demonstrating a statistically significant greater improvement in TMC score with INGREZZA versus placebo.1,2  "We are proud to bring INGREZZA to people living with HD and their caregivers who now have the option of a one-capsule, once-daily treatment that has demonstrated significant improvement in HD chorea in clinical studies," said Kevin C.

Neurocrine Biosciences Announces FDA Approval of INGREZZA® (valbenazine) Capsules for the Treatment of Chorea Associated With Huntington's Disease

Although the revenue and EPS for Neurocrine (NBIX) give a sense of how its business performed in the quarter ended June 2023, it might be worth considering how some key metrics compare with Wall Street estimates and the year-ago numbers.

Neurocrine (NBIX) Reports Q2 Earnings: What Key Metrics Have to Say

Neurocrine Biosciences (NBIX) came out with quarterly earnings of $0.95 per share, beating the Zacks Consensus Estimate of $0.77 per share. This compares to loss of $0.18 per share a year ago.

Neurocrine Biosciences (NBIX) Q2 Earnings and Revenues Surpass Estimates

INGREZZA® (valbenazine) Second Quarter Net Product Sales of $440 Million Representing 26% Year-Over-Year Growth INGREZZA® (valbenazine) 2023 Net Product Sales Guidance Raised to $1.77 - $1.82 Billion SAN DIEGO, Aug. 1, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the second quarter ended June 30, 2023 and raised net sales guidance for INGREZZA in 2023. "INGREZZA's performance reflects the significant benefit the medicine is providing to patients with tardive dyskinesia enabling us to raise guidance once again," said Kevin Gorman, Ph.D.

Neurocrine Biosciences Reports Second Quarter 2023 Financial Results and Raises 2023 INGREZZA Sales Guidance

SAN DIEGO , July 11, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that it appointed Christine A. Poon, a business leader with extensive experience in the pharmaceutical industry, to its Board of Directors.

Neurocrine Biosciences Announces Appointment of Christine A. Poon to Board of Directors

Conference Call and Webcast Scheduled for Tuesday, August 1 SAN DIEGO , July 11, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that it has scheduled its second quarter 2023 financial results conference call and webcast for 5:00 a.m. Pacific Time (8:00 a.m.

Neurocrine Biosciences Announces Conference Call and Webcast of Second Quarter 2023 Financial Results

SAN DIEGO , June 15, 2023 /PRNewswire/ -- Diurnal Ltd., a Neurocrine Biosciences company (Nasdaq: NBIX), today announced that it will present new post hoc analyses of Phase 3 extension study data for modified-release hydrocortisone (approved as EFMODY® in United Kingdom and European Union), which is being investigated as a treatment for adults with congenital adrenal hyperplasia (CAH), at ENDO 2023 June 15–18 in Chicago.

Diurnal Ltd., a Neurocrine Biosciences Company, Presents Phase 3 Extension Study Data for Modified-Release Hydrocortisone in Patients with Congenital Adrenal Hyperplasia at ENDO 2023

SAN DIEGO , June 8, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) will present at the Goldman Sachs 44th Annual Global Healthcare Conference on Thursday, June 15, 2023 at 8:00 a.m. Pacific Time (11:00 a.m.

Neurocrine Biosciences to Present at the Goldman Sachs 44th Annual Global Healthcare Conference

SAN DIEGO , June 2, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today presented findings from a meta-analysis of three long-term studies evaluating INGREZZA® (valbenazine) capsules that demonstrated substantial and sustained improvements in tardive dyskinesia (TD) in adults with or without concomitant antipsychotic therapy. The data (Poster #4) were presented at 2023 Psych Congress Elevate in Las Vegas.

Neurocrine Biosciences Presents INGREZZA® (valbenazine) Capsules Data on Tardive Dyskinesia Improvement Regardless of Baseline Antipsychotic Use at 2023 Psych Congress Elevate

-  Statistically Significant Improvement in Chorea Associated with Huntington's Disease Seen as Early as Week 2 -  Chorea Improvement Supported by Statistically Significant Clinical Global Impression of Change (CGI-C) Response Status and Patient Global Impression of Change (PGI-C) Response Status Scores at Week 12 -  First Phase 3 Study to Implement Huntington's Disease Health Index (HD-HI), a Patient-Reported Outcome Measure, Showed Reduced Disease Burden as Reported by Patients Receiving Valbenazine versus Placebo -  Supplemental New Drug Application (sNDA) Filed, with Prescription Drug User Fee Act (PDUFA) Target Date Set for August 20, 2023 SAN DIEGO , May 19, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced that the complete study results from its Phase 3 KINECT™-HD study investigating valbenazine for the treatment of chorea associated with Huntington's disease (HD) has been published in The Lancet Neurology online edition and will appear in the June 2023 print issue. The study met pre-defined primary and secondary endpoints of improvement in chorea severity and global impression of change, demonstrating a reduction in chorea symptoms associated with HD and improvement of overall chorea severity as noticed by clinicians and patients, with improvement seen as early as Week 2 of the initial dose in the 12-week study.

Neurocrine Biosciences Announces Publication of Full KINECT™-HD Phase 3 Study Results of Valbenazine for the Treatment of Chorea Associated with Huntington's Disease in The Lancet Neurology

SAN DIEGO , May 15, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced findings from a post hoc analysis of two long-term studies (KINECT™ 3 and KINECT™ 4) of INGREZZA® (valbenazine) capsules evaluating global tardive dyskinesia (TD) improvement and stability of psychiatric symptoms in adults with TD and schizophrenia or schizoaffective disorder. The data (Poster #SA135) was presented at the Schizophrenia International Research Society (SIRS) 2023 Annual Congress in Toronto, Canada.

Neurocrine Biosciences Presents INGREZZA® (valbenazine) Capsules Data on Long-Term Improvements and Psychiatric Stability in Patients With Tardive Dyskinesia and Schizophrenia or Schizoaffective Disorder at the Schizophrenia International Research Society

Post Hoc Analyses of Phase 2 Study of Crinecerfont in Adults with CAH Demonstrate Androgen Reduction Across a Broad Range of Glucocorticoid Doses Post Hoc Analyses of Phase 3 Study Demonstrate EFMODY® (hydrocortisone modified-release hard capsules) Reduced Androgen Levels Compared to Immediate-Release Hydrocortisone in Patients with CAH SAN DIEGO , May 12, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), a leading neuroscience-focused biopharmaceutical company, today announced that it will present new analyses of Phase 2 data of the investigational drug crinecerfont in adults with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency (21-OHD) and post hoc analyses of Phase 3 data for EFMODY® (hydrocortisone modified-release hard capsules). EFMODY is approved by the European Commission for the European Economic Area (including Northern Ireland) (EEA) and by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of adults and adolescents (12 years and older) with CAH.

Neurocrine Biosciences Presents Data on Treatment of Patients with Congenital Adrenal Hyperplasia at ECE 2023

Neurocrine Biosciences, Inc. (NASDAQ:NBIX ) Q1 2023 Earnings Conference Call May 3, 2023 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 Philip Nadeau - Cowen & Company Tazeen Ahmad - Bank of America Paul Matteis - Stifel Josh Schimmer - Evercore Neena Bitritto-Garg - Citi Chris Shibutani - Goldman Sachs Brian Abrahams - RBC Capital Markets Anupam Rama - JPMorgan Carter Gould - Barclays Myles Minter - William Blair Marc Goodman - SVB Securities Brian Skorney - Baird Danielle Brill - Raymond James Jay Olson - Oppenheimer Laura Chico - Wedbush Securities Sumant Kulkarni - Canaccord Genuity David Amsellem - Piper Sandler Akash Tewari - Jefferies Ashwani Verma - UBS Yatin Suneja - Guggenheim Partners Uy Ear - Mizuho Securities Ami Fadia - Needham Operator Good day, everyone, and welcome to the Neurocrine Biosciences Reports First Quarter Results. At this time, all participants are in a listen-only mode.

Neurocrine Biosciences, Inc. (NBIX) Q1 2023 Earnings Call Transcript

Neurocrine Biosciences (NBIX) came out with a quarterly loss of $0.79 per share versus the Zacks Consensus Estimate of $0.26. This compares to earnings of $0.14 per share a year ago.

Neurocrine Biosciences (NBIX) Reports Q1 Loss, Tops Revenue Estimates

INGREZZA® (valbenazine) First Quarter Net Product Sales of $410 Million INGREZZA® (valbenazine) 2023 Net Product Sales Guidance Reiterated at $1.67 - $1.77 Billion SAN DIEGO , May 3, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the first quarter ended March 31, 2023 and provided an update on its 2023 financial guidance. "INGREZZA's first quarter results highlight the steady progress we are making to help improve the lives of patients living with tardive dyskinesia, yet we still have a tremendous opportunity to help even more patients for many years to come," said Kevin Gorman, Ph.D.

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