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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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® (valbenazine) Fourth Quarter and Full Year 2023 Net Product Sales of $500 Million and $1.84 Billion, Representing Year-over-Year Growth of 25% and 29% Respectively INGREZZA® (valbenazine) Full Year 2024 Net Product Sales Guidance of $2.1 - $2.2 Billion Crinecerfont FDA Regulatory Submission Anticipated in the Second Quarter for the Treatment of Congenital Adrenal Hyperplasia in Adults and Pediatrics SAN DIEGO , Feb. 7, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the fourth quarter and full year ended December 31, 2023 and provided financial guidance for 2024. "I'm exceptionally proud of the progress we made with INGREZZA last year, helping more patients than ever before treat their tardive dyskinesia.

Neurocrine Biosciences Reports Fourth Quarter and Fiscal 2023 Financial Results and Provides Financial Expectations for 2024

Evaluate the expected performance of Neurocrine (NBIX) for the quarter ended December 2023, looking beyond the conventional Wall Street top-and-bottom-line estimates and examining some of its key metrics for better insight.

Ahead of Neurocrine (NBIX) Q4 Earnings: Get Ready With Wall Street Estimates for Key Metrics

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Investors with an interest in Medical - Drugs stocks have likely encountered both Amylyx Pharmaceuticals, Inc. (AMLX) and Neurocrine Biosciences (NBIX). But which of these two companies is the best option for those looking for undervalued stocks?

AMLX vs. NBIX: Which Stock Should Value Investors Buy Now?

Conference Call and Webcast Scheduled for Wednesday, February 7 SAN DIEGO , Jan. 17, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that it has scheduled its fourth quarter and year-end 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 Fourth Quarter and Year-End 2023 Financial Results

Neurocrine (NBIX) has seen solid earnings estimate revision activity over the past month, and belongs to a strong industry as well.

How Neurocrine (NBIX) Stock Stands Out in a Strong Industry

SAN DIEGO , Jan. 2, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) will present at the 42nd Annual J.P. Morgan Healthcare Conference at 9:45 a.m.

Neurocrine Biosciences to Present at the 42nd Annual J.P. Morgan Healthcare Conference

Neurocrine (NBIX) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might help the stock continue moving higher in the near term.

Neurocrine (NBIX) Soars 6.0%: Is Further Upside Left in the Stock?

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BEIJING & SAN DIEGO--(BUSINESS WIRE)--Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (“Biocytogen”, HKEX: 02315) today announced that it has entered into an antibody evaluation and option agreement with Neurocrine Biosciences, Inc. The agreement grants Neurocrine Biosciences access to Biocytogen's fully human antibodies against multiple specified targets, with an option to license selected antibodies for therapeutic product development, manufacturing and commercialization for all uses worldwide.

Biocytogen Enters into Multi-Target Antibody Agreement with Neurocrine Biosciences

BEIJING & SAN DIEGO--(BUSINESS WIRE)-- #Biocytogen--Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (“Biocytogen”, HKEX: 02315) today announced that it has entered into an antibody evaluation and option agreement with Neurocrine Biosciences, Inc. The agreement grants Neurocrine Biosciences access to Biocytogen's fully human antibodies against multiple specified targets, with an option to license selected antibodies for therapeutic product development, manufacturing and commercialization for all uses worldwide.

Biocytogen Enters into Multi-Target Antibody Agreement With Neurocrine Biosciences

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Tokyo, Japan and Cambridge, UK, 6 December 2023 – Sosei Group Corporation (“the Company”; TSE: 4565), notes its partner Neurocrine Biosciences Inc. (“Neurocrine”; Nasdaq: NBIX), a leading neuroscience-focused biopharmaceutical company, has confirmed its plans to evaluate two new muscarinic agonist candidates in Phase 1 first-in-human clinical studies. The studies are designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of NBI-1117569 and NBI-1117567 in healthy adult participants. NBI-1117569, a muscarinic M4-preferring agonist, and NBI-1117567, a muscarinic M1-preferring agonist are both investigational, oral compounds that may have the potential to treat neurological and neuropsychiatric conditions and were developed utilizing Sosei Heptares' structure-based drug design platform. Neurocrine confirmed a Phase 1 clinical study of NBI-1117569 has started and a Phase 1 study of NBI-1117567 will be initiated in 2024.

Sosei Heptares' Partner Neurocrine Biosciences Confirms its Plans to Evaluate Two New Muscarinic Agonist Candidates in Phase 1 Clinical Studies

Company Today Also Provided Updates on R&D Portfolio and Strategy at Investor Event  Crinecerfont New Drug Application Submission Planned in 2024 NBI-'770, an Oral NMDA NR2B Negative Allosteric Modulator, Entering Phase 2 for the Treatment of Major Depressive Disorder Advancing Largest Portfolio of Muscarinic Compounds in Clinical Development Top-Line Phase 2 Data Readouts for Five Programs Anticipated in 2024 Including NBI-'568, an M4 Agonist, for the Treatment of Schizophrenia SAN DIEGO , Dec. 5, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced it received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for crinecerfont in congenital adrenal hyperplasia. The Company also provided updates on its R&D portfolio and strategy at its Analyst Day, held in New York.

Neurocrine Biosciences Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Crinecerfont in Congenital Adrenal Hyperplasia

SAN DIEGO , Dec. 1, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), a leading neuroscience-focused biopharmaceutical company, will hold its Analyst Day focused on its R&D portfolio and strategy on Tuesday, December 5, 2023 in New York. The event will be held in-person and via webcast.

Neurocrine Biosciences to Host Analyst Day on December 5, 2023

Neurocrine Biosciences' stock has been stagnant due to a lack of appreciation for positive updates and the modest mid-stage pipeline setbacks. The company recently settled with generic filers, ensuring no generic launch of Ingrezza until 2038 and highlighting the strength of its intellectual property. The concerns over the impact of the Inflation Reduction Act on Ingrezza seem overblown.

Neurocrine Biosciences: Fear Not The IRA

SAN DIEGO , Nov. 13, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), a leading neuroscience-focused biopharmaceutical company, today announced that is has resolved all patent litigation related to lawsuits resulting from Abbreviated New Drug Applications (ANDAs) brought by companies seeking approval to market a generic version of INGREZZA® (valbenazine) prior to the expiration of applicable Neurocrine patents.  As part of the resolution of these lawsuits, four companies have the right to sell generic versions of INGREZZA in the United States beginning March 1, 2038, or earlier under certain customary circumstances.

Neurocrine Biosciences Announces Settlement of INGREZZA Abbreviated New Drug Application (ANDA) Litigation

Neurocrine Biosciences Inc. shares NBIX, -2.81% fell 4.7% premarket on Friday after the company on Thursday announced two clinical trial failures.

Neurocrine Biosciences shares drop as trial failures may ‘stunt momentum,' analysts say

Phase 2 Proof-of-Concept Study of NBI-921352 in Patients with Focal Onset Seizures Failed to Demonstrate Meaningful Reduction in Seizure Frequency Phase 2 Proof-of-Concept Study of NBI-1065846 in Patients with Anhedonia in Major Depressive Disorder Failed to Meet its Primary Endpoint SAN DIEGO , Nov. 9, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), a leading neuroscience-focused biopharmaceutical company, today announced Phase 2 study results from two signal-seeking pipeline programs in focal onset seizures and anhedonia. "We are disappointed with the outcome of these studies, but remain fully committed to finding new treatment options for patients living with serious neurological and neuropsychiatric disorders, including epilepsy and major depressive disorder," said Eiry W.

Neurocrine Biosciences Provides Development Pipeline Update

SAN DIEGO , Nov. 8, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the availability of DISCOVER TD™, an interactive digital tool designed to help healthcare providers learn about and identify tardive dyskinesia. Built in collaboration with clinical experts and Level Ex, "the world's leading medical video game studio," DISCOVER TD uses gameplay, artistry, and cutting-edge technology to bring patient visits to life in realistic detail.

Neurocrine Biosciences Launches Interactive Digital Tool for use by Healthcare Providers to Help Expand Education on Identifying and Diagnosing Tardive Dyskinesia

SAN DIEGO , Nov. 8, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) will present at the Jefferies London Healthcare Conference on Tuesday November 14, 2023 at 3:00 p.m. Greenwich Mean Time (10:00 a.m.

Neurocrine Biosciences to Present at the Jefferies London Healthcare Conference

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SAN DIEGO , Nov. 2, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced interim results from the ongoing open-label KINECT®-HD2 study about INGREZZA® (valbenazine) capsules when used for the long-term treatment of adults with chorea associated with Huntington's disease (HD). Interim data suggest one-capsule, once-daily INGREZZA improved chorea at the first evaluation at Week 2 with sustained efficacy through Week 50.

Neurocrine Biosciences® Presents INGREZZA® (valbenazine) Capsules Interim Data Demonstrating Sustained Improvements in Chorea Associated With Huntington's Disease Through Week 50 at Huntington Study Group 2023

Neurocrine Biosciences, Inc. (NASDAQ:NBIX ) Q3 2023 Earnings Conference Call October 31, 2023 8:00 AM ET Company Participants Todd Tushla - Vice President, Investor Relations Kevin Gorman - Chief Executive Officer Matt Abernethy - Chief Financial Officer Eiry Roberts - Chief Medical Officer Eric Benevich - Chief Commercial Officer Kyle Gano - Chief Business Development and Strategy Officer Conference Call Participants Phil Nadeau - TD Cowen Chris Shibutani - Goldman Sachs Paul Matteis - Stifel Tazeen Ahmad - Bank of America Brian Abrahams - BRC Capital Markets Josh Schimmer - Cantor Leon Wang - Barclays Anupam Rama - JPMorgan Jay Olson - Oppenheimer Marc Goodman - Leerink Partners Michael Riad - Morgan Stanley Myles Minter - William Blair Yatin Suneja - Guggenheim Partners Laura Chico - Wedbush Securities Sumant Kulkarni - Canaccord David Amsellem - Piper Sandler Ash Verma - UBS Ami Fadia - Needham Uy Ear - Mizuho Conor MacKay - BMO Capital Markets Operator Good day, everyone. And welcome to the Neurocrine Biosciences Reports third quarter results.

Neurocrine Biosciences, Inc. (NBIX) Q3 2023 Earnings Call Transcript

The headline numbers for Neurocrine (NBIX) give insight into how the company performed in the quarter ended September 2023, but it may be worthwhile to compare some of its key metrics to Wall Street estimates and the year-ago actuals.

Neurocrine (NBIX) Q3 Earnings: How Key Metrics Compare to Wall Street Estimates

INGREZZA® (valbenazine) Third Quarter Net Product Sales of $486 Million Representing 29% Year-Over-Year Growth INGREZZA® (valbenazine) 2023 Net Product Sales Guidance Raised to $1.82 - $1.84 Billion Crinecerfont Adult and Pediatric CAHtalystTM Studies Met Primary Endpoint and Key Secondary Endpoints for the Treatment of Congenital Adrenal Hyperplasia Analyst Day on December 5th Focused on R&D Portfolio and Strategy SAN DIEGO , Oct. 31, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the third quarter ended September 30, 2023, raised 2023 net sales guidance for INGREZZA, and announced an Analyst Day to be held in New York City on December 5th. "With INGREZZA sales continuing to grow, an expanded indication to treat chorea associated with Huntington's disease, and positive Phase 3 results in congenital adrenal hyperplasia, Neurocrine remains well positioned to build a leading neuroscience-focused company," said Kevin Gorman, Ph.D.

News for Neurocrine Biosciences Stock (NBIX)