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 Q3 2023

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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.

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 pharmacy Neurocrine Access Support is available to provide free, comprehensive access and support information to patients, caregivers and healthcare providers SAN 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).

Neurocrine Biosciences Announces Commercial Availability of CRENESSITY™ (crinecerfont) for Children and Adults With Classic Congenital Adrenal Hyperplasia

Neurocrine's Ingrezza is forecasted to generate $2.3 billion in revenue in 2024, cementing its role as the company's primary revenue driver. Crenessity's approval for CAH treatment represents a transformative opportunity. Peak sales are estimated at $1.47 billion by 2030. Neurocrine's pipeline includes five Phase 1, six Phase 2, and two Phase 3 programs, diversifying future growth opportunities.

Neurocrine Biosciences' Crenessity Approval Sets Stage For Diversified Revenue And Growth

Neurocrine Biosciences won Food and Drug Administration approval late Friday for the first new treatment for an adrenal disease in decades. The post Neurocrine Wins FDA Approval For Genetic Disorder Drug appeared first on Investor's Business Daily.

Neurocrine Wins FDA Approval For Genetic Disorder Drug

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 Rare Pediatric Disease Priority Review Voucher granted in connection with approval SAN DIEGO , Dec. 13, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration has approved CRENESSITY™ (crinecerfont) capsules and oral solution 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), a rare, serious and lifelong genetic condition involving the adrenal glands. CRENESSITY, a potent and selective oral corticotropin-releasing factor type 1 receptor (CRF1) antagonist, is the first and only classic CAH treatment that directly reduces excess adrenocorticotropic hormone (ACTH) and downstream adrenal androgen production, allowing for glucocorticoid dose reduction.

Neurocrine Biosciences Announces FDA Approval of CRENESSITY™ (crinecerfont), a First-in-Class Treatment for Children and Adults With Classic Congenital Adrenal Hyperplasia

The U.S. Food and Drug Administration has approved Neurocrine Biosciences' drug to treat a type of genetic disorder, the health regulator's website showed on Friday.

US FDA approves Neurocrine Biosciences' genetic disorder drug

The 7th Annual Evercore HealthCONx Conference on December 3 Citi's 2024 Global Healthcare Conference on December 4 SAN DIEGO , Nov. 26, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) will participate at two upcoming investor conferences in December. Chief Executive Officer Kyle Gano, Chief Financial Officer Matt Abernethy, and Vice-President of Investor Relations Todd Tushla will present at: The 7th Annual Evercore HealthCONx Conference at 10:50 a.m.

Neurocrine Biosciences to Participate at Investor Conferences in December

Neurocrine Biosciences, Inc.'s August share price decline after the messy phase 2 results of NBI-568 in schizophrenia patients is understandable, but the magnitude is not. Neurocrine is trading at slow growth big pharma multiples, not at multiples of a company with significant growth potential that it is. Ingrezza continues to deliver strong growth and cash flows for the company, and crinecerfont will be launched in early 2025.

Why Neurocrine Biosciences Stock Is Very Attractive At Current Levels

Data Support Positive Impact of INGREZZA in People With Huntington's Disease Chorea Findings Presented at the 2024 Annual Meeting of the Huntington Study Group SAN DIEGO , Nov. 7, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today presented subgroup analyses and data from the KINECT®-HD study showing the impact of INGREZZA® (valbenazine) capsules on emotional health and psychiatric stability in patients with chorea associated with Huntington's disease. The subgroup analysis showed consistent efficacy in reducing chorea compared to placebo across all identified subgroups, categorized by demographics and baseline assessment scores.

Neurocrine Biosciences Presents New KINECT®-HD Data Showing Consistent Efficacy Across 19 Subgroups and Improvements in Aspects of Emotional Health With INGREZZA® (valbenazine) Capsules

2024 UBS Global Healthcare Conference on November 12 Stifel 2024 Healthcare Conference on November 18 Jefferies London Healthcare Conference on November 19 SAN DIEGO , Nov. 5, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) will participate at three upcoming investor conferences in November. Chief Executive Officer Kyle Gano, Chief Financial Officer Matt Abernethy, and Vice-President of Investor Relations Todd Tushla will present at the 2024 UBS Global Healthcare Conference at 1:15 p.m.

Neurocrine Biosciences to Participate at Investor Conferences in November

Findings Presented at the 2024 Psych Congress Include Data From More Than 300 Patients SAN DIEGO , Nov. 4, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) presented data from more than 300 patients diagnosed with tardive dyskinesia and treated with INGREZZA® (valbenazine) capsules. These data showed significant improvements in functional, social, emotional and health-related quality of life measures in Phase 3 and 4 studies and improvements in functional, social, independence, emotional and physical aspects of patients' lives and antipsychotic adherence in real-world practice.

Neurocrine Biosciences Presents Breadth of Data Demonstrating Holistic Improvements Over Time in Patients With Tardive Dyskinesia Following Treatment With INGREZZA® (valbenazine) Capsules

SAN DIEGO , Nov. 4, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) presented data from the long-term KINECT®-4 study demonstrating tardive dyskinesia remission in nearly 60% of participants at Week 48 with once-daily INGREZZA® (valbenazine) capsules treatment. This research, "Remission of Tardive Dyskinesia in Patients Receiving Long-Term Valbenazine Treatment" (Poster #98), was shared at the 2024 Psych Congress in Boston.

Neurocrine Biosciences Presents New Data on INGREZZA® (valbenazine) Capsules at Psych Congress 2024: Majority of Long-Term Study Participants Achieved Remission of Tardive Dyskinesia

Neurocrine Biosciences, Inc. (NASDAQ:NBIX ) Q3 2024 Earnings Conference Call August 30, 2024 8:00 AM ET Company Participants Kyle Gano - Chief Executive Officer Matt Abernethy - Chief Financial Officer Eric Benevich - Chief Commercial Officer Eiry Roberts - Chief Medical Officer Todd Tushla - Vice President of Investor Relations Conference Call Participants Chris Shibutani - Goldman Sachs Paul Matteis - Stifel David Ansellem - Piper Sandler Phoebe Tan - Jefferies Tazeen Ahmad - Bank of America Securities Jay Olson - Oppenheimer Ash Verma - UBS Philip Nadeau - TD Cowen Anupam Rama - J.P. Morgan Evan Seigerman - BMO Capital Markets Cory Kasimov - Evercore ISI Carter Gould - Barclays Mohit Bansal - Wells Fargo Marc Goodman - Leerink Partners Myles Minter - William Blair Michael Riad - Morgan Stanley Laura Chico - Wedbush Securities Yatin Suneja - Guggenheim Securities Uy Ear - Mizuho Securities Ami Fadia - Needham Operator Good day, everyone and welcome to Neurocrine Biosciences' reports Third Quarter Results.

Neurocrine Biosciences, Inc. (NBIX) Q3 2024 Earnings Call Transcript

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

Neurocrine (NBIX) Q3 Earnings: Taking a Look at Key Metrics Versus Estimates

Neurocrine Biosciences (NBIX) came out with quarterly earnings of $1.24 per share, missing the Zacks Consensus Estimate of $1.47 per share. This compares to earnings of $0.82 per share a year ago.

Neurocrine Biosciences (NBIX) Q3 Earnings Miss Estimates

INGREZZA® (valbenazine) Third Quarter Net Product Sales of $613 Million Representing 26% Year-Over-Year Growth INGREZZA ® (valbenazine) 2024 Net Product Sales Guidance Raised to $2.30 - $2.32 Billion Board Authorizes $300 Million Share Repurchase Plan SAN DIEGO , Oct. 30, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the third quarter ended September 30, 2024 and provided an update on its 2024 financial guidance. "With continued INGREZZA growth across the tardive dyskinesia and Huntington's disease chorea indications, FDA Priority Review for crinecerfont in congenital adrenal hyperplasia, a deep neuroscience focused pipeline and a strong balance sheet, we are confident in our ability to help more patients than ever before," said Kyle W.

Neurocrine Biosciences Reports Third Quarter 2024 Financial Results and Raises 2024 INGREZZA Sales Guidance

Neurocrine (NBIX) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Neurocrine Biosciences (NBIX) Earnings Expected to Grow: Should You Buy?

Neurocrine Biosciences' Ingrezza has grown into a multibillion-dollar drug, but the company's stock has underperformed the S&P 500 since 2019. Neurocrine's NBI-1117568 demonstrated encouraging Phase 2 schizophrenia data, though dose inconsistencies raised questions about efficacy. The stock's recent decline is an overreaction, presenting a buying opportunity given its CNS pipeline and Ingrezza's ongoing growth.

Neurocrine: A Buy Amid CNS Pipeline Growth And Ingrezza's Strength (Rating Upgrade)

Conference Call and Webcast Scheduled for Wednesday, October 30 SAN DIEGO , Oct. 9, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that it has scheduled its third quarter 2024 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 Third Quarter 2024 Financial Results

KINECT®-HD2 Is the First Prospective Clinical Trial to Include Patients Taking Antipsychotic Medication in a Study Evaluating a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor for the Treatment of Huntington's Disease Chorea Findings Presented at the 2024 MDS International Congress of Parkinson's Disease and Movement Disorders® SAN DIEGO , Sept. 30, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced interim results from the ongoing open-label KINECT®-HD2 study of INGREZZA® (valbenazine) capsules for the long-term treatment of adults with chorea associated with Huntington's disease.

Neurocrine Biosciences Presents Interim Data Demonstrating Robust and Sustained Improvements in Chorea Associated With Huntington's Disease Through Week 104 Irrespective of Antipsychotic Use

SAN DIEGO , Sept. 19, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) will participate at the TD Cowen 4th Annual Novel Mechanisms in Neuropsychiatry Virtual Summit at 11:00 a.m.

Neurocrine Biosciences to Participate at the TD Cowen 4th Annual Novel Mechanisms in Neuropsychiatry Virtual Summit

Neurocrine Biosciences said its experimental drug did not achieve the primary goal in a mid-stage trial aimed at improving cognitive function in patients with schizophrenia.

Neurocrine's experimental drug misses primary goal in schizophrenia trial

Second Phase 2 Study for Luvadaxistat Fails to Meet Primary Endpoint as Potential Treatment for Cognitive Impairment Associated with Schizophrenia Results Confounded by Variability in Cognition Measures Across Population Studied and Potential Imbalance in Baseline Characteristics of Enrolled Subjects Neurocrine Biosciences to Focus Resources on Phase 3 Clinical Development of NBI-1117568 for Schizophrenia and NBI-1065845 for Major Depressive Disorder SAN DIEGO , Sept. 12, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that its ERUDITE™ Phase 2 clinical study of investigational compound luvadaxistat (NBI-1065844) failed to meet its primary endpoint as a potential treatment to improve cognitive impairment in patients with schizophrenia.

Neurocrine Biosciences Provides Update on ERUDITE™ Phase 2 Data for Luvadaxistat in Adults with Cognitive Impairment Associated with Schizophrenia

SAN DIEGO , Sept. 10, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) will participate at the 2024 Cantor Global Healthcare Conference in New York at 3:05 p.m.

Neurocrine Biosciences to Participate at the 2024 Cantor Global Healthcare Conference

Tokyo, Japan and Cambridge, UK, 2 September 2024 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) – formerly known as Sosei Group or Sosei Heptares – announces that it will receive a US$35 million payment from Neurocrine Biosciences (‘Neurocrine'), triggered by the successful completion of the Phase 2 trial with NBI-1117568 (NBI-‘568) in adults with schizophrenia, as announced on 28 August 2024. Receipt of the US$35 million payment will be recognized as one-time revenue in the third quarter of 2024.

Nxera Pharma to Receive US$35 Million from Neurocrine Biosciences upon Positive Phase 2 Data for Partnered Schizophrenia Candidate NBI-1117568

The biotech released the results of phase 2 clinical trial of its investigational schizophrenia drug. One of the four doses clearly performed well.

News for Neurocrine Biosciences Stock (NBIX)