Core Insights - Neurocrine Biosciences, Inc. (NASDAQ: NBIX) has experienced a strong six-month performance with double-digit gains, recovering from 52-week lows recorded in April 2025, although the past month has seen marginal losses of less than one percent [1] Company Performance - The stock of Neurocrine Biosciences, Inc. has shown significant recovery over the last six months, indicating positive market sentiment and potential growth opportunities [1] Analyst Background - Gamu Dave Innocent Pasi is a seasoned financial professional with extensive experience in financial analysis and investment research, contributing to reputable publications and focusing on actionable trading ideas and investment recommendations [1] Investment Philosophy - Gamu emphasizes the importance of Responsible Investment and actively promotes Environmental, Social, and Governance (ESG) principles in investment decision-making, reflecting a growing trend in the investment community towards sustainability and social impact [1] Future Focus - The company is currently focused on building a new international investment portfolio, indicating a strategic move towards global market engagement and diversification [1]

Core Insights - Neurocrine Biosciences, Inc. (NASDAQ: NBIX) has experienced a strong six-month performance with double-digit gains, recovering from 52-week lows recorded in April 2025, although the past month has seen marginal losses of less than one percent [1] Company Performance - The stock of Neurocrine Biosciences, Inc. has shown significant recovery over the last six months, indicating positive market sentiment and potential investor confidence [1] Analyst Background - Gamu Dave Innocent Pasi is a seasoned financial professional with extensive experience in financial analysis and investment research, contributing to reputable publications and focusing on actionable trading ideas and investment recommendations [1] Investment Philosophy - Gamu emphasizes the importance of Responsible Investment and actively promotes Environmental, Social, and Governance (ESG) principles in investment decision-making, reflecting a growing trend in the investment community towards sustainability and social impact [1] Future Focus - The company is currently focused on building a new international investment portfolio, indicating a strategic move towards global market engagement and diversification [1]

Core Insights - Neurocrine Biosciences presented a post-hoc analysis from the Phase 3 KINECT 4 study, showing that continuous treatment with INGREZZA (valbenazine) at a 40 mg dose for 48 weeks led to significant improvements in tardive dyskinesia (TD) symptoms [1][5][6] Study Findings - The KINECT 4 study demonstrated that 90% of participants who completed 48 weeks of treatment with INGREZZA 40 mg achieved a 50% improvement in the Abnormal Involuntary Movement Scale (AIMS) total score [5][6] - Efficacy was assessed through clinician- and patient-reported measures, with sustained improvements observed throughout the treatment period [4][6] - The analysis included 45 patients on the 40 mg dose and 11 patients who escalated to 80 mg before reducing back to 40 mg, showing similar therapeutic benefits [3][6] Safety and Tolerability - The safety profile of INGREZZA remained consistent with previous studies, with most treatment-emergent adverse events being mild to moderate [4][9] - Common side effects included sleepiness and tiredness, with no new safety concerns identified during the study [4][20] Treatment Flexibility - INGREZZA is unique as the only VMAT2 inhibitor that allows patients to start at a therapeutic dose without the need for titration, providing flexibility in dosing based on individual response and tolerability [2][10]

Conference Call and Webcast Scheduled for Tuesday, October 28 , /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that it has scheduled its third quarter 2025 financial results conference call and webcast for 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time) on October 28, 2025. The schedule for the press release and conference call / webcast is as follows: The webcast can also be accessed on Neurocrine Biosciences' website under Investors at www.neurocrine.com. A replay of the webca ...

Core Insights - Neurocrine Biosciences presented new data from the KINECT-HD2 study, showing long-term safety, tolerability, and sustained improvements in chorea severity with once-daily INGREZZA (valbenazine) in adults with Huntington's disease [1][2] Study Findings - The KINECT-HD2 study involved 154 adult participants treated with INGREZZA for up to three years, demonstrating early and sustained improvements in chorea severity [2][7] - Improvements in the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) score were observed as early as Week 2, with a mean improvement of -3.4±0.3 at the lowest dose of 40 mg [5] - By Week 156, 77.8% of participants reported a "much improved" status on the Patient Global Impression of Change (PGI-C) score [5] Safety and Tolerability - INGREZZA was generally well tolerated, with treatment-emergent adverse events (TEAEs) consistent with its established safety profile [3][5] - The most common TEAEs included falls (42.9%), somnolence (25.3%), and fatigue (21.4%), with serious TEAEs occurring in less than 2% of participants [5] Efficacy Analysis - The study indicated that concomitant antipsychotic use had no effect on chorea improvement, suggesting that INGREZZA can be used alongside other medications without compromising efficacy [2][5] - Efficacy was maintained throughout the treatment period, with significant improvements noted at various time points from Week 2 to Week 156 [5] About INGREZZA - INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved for treating chorea associated with Huntington's disease and tardive dyskinesia [7][8] - The drug is available in 40 mg, 60 mg, and 80 mg capsules, and offers a sprinkle formulation for patients with swallowing difficulties [9]

Core Insights - PGIM Jennison Health Sciences Fund's second-quarter 2025 investor letter highlights significant volatility in equities, with the S&P 1500 Health Care Index declining 6.9% while the S&P 500 returned 10.9% [1] - The fund's top holdings include Neurocrine Biosciences, Inc., which has shown a one-month return of 5.56% and a 52-week gain of 26.52% [2] Market Performance - The S&P 1500 Health Care Index underperformed the S&P 500 in June, gaining only 1.9% compared to the S&P 500's 5.1% [1] - Health care providers & services, life sciences tools & services, biotechnology, and pharmaceuticals underperformed the Index, while healthcare technology and medtech sectors gained [1] Company Focus: Neurocrine Biosciences, Inc. - Neurocrine Biosciences, Inc. reported stronger than expected first-quarter results and remains optimistic about its second-quarter performance, indicating a recovery from previous guidance issues [3] - As of September 24, 2025, Neurocrine's stock closed at $146.67 with a market capitalization of $14.547 billion [2] - The number of hedge funds holding Neurocrine decreased from 63 to 59 in the second quarter, suggesting a shift in investment interest [3]

Core Insights - The KINECT-PRO analysis is the first and only study to report both remission of tardive dyskinesia symptoms and improvements in patient-reported outcomes [1] - Post-hoc analysis from KINECT-PRO showed substantial symptomatic remission rates at Week 24, occurring earlier than in previous studies [1]

Core Insights - Neurocrine Biosciences, Inc. announced new data from the Phase 2 SAVITRI study demonstrating significant improvement in depression severity at Day 28 and Day 56 with the administration of 1 mg osavampator (NBI-1065845) [1] Group 1 - The Phase 2 SAVITRI study showed statistically significant improvement in depression severity [1] - The improvement was clinically meaningful at both Day 28 and Day 56 [1] - The treatment involved once-daily oral administration of 1 mg osavampator [1]

Group 1 - Neurocrine is focusing on developing and commercializing drugs for neuropsychiatric conditions, with a strategic shift in R&D approach [1][2] - The company has an upcoming R&D Day on December 16, where further details on the evolution of its strategy will be shared [1] - The current pipeline has been largely in-licensed through business development, which will continue to be a significant part of Neurocrine's strategy [2]

Summary of Neurocrine Biosciences FY Conference Call Company Overview - **Company**: Neurocrine Biosciences (NasdaqGS:NBIX) - **Date**: September 17, 2025 - **Key Speakers**: Kyle Gano (CEO), Sanjay Keswani (CMO), Todd Tushla (VP of Investor Relations) Key Points R&D Strategy and Pipeline - Neurocrine is shifting its R&D strategy to focus on internal drug discovery rather than solely in-licensing programs, aiming to enhance R&D productivity [2][3] - The company plans to initiate four new phase 1 programs, two new phase 2 programs, and maintain at least three programs in phase 3 development annually, potentially leading to one new medicine every two years [4] - Therapeutic areas of focus include neurology, psychiatry, endocrinology, and immunology, with a particular emphasis on CNS-related targets [5][6] Portfolio Risk Management - The current portfolio is weighted more towards psychiatry due to recent successes, with future expectations of a balanced distribution: 40-50% neurology, 20-30% psychiatry, 10-20% endocrinology, and 10-20% immunology [8][9] Specific Programs - **NBI-770**: An NMDA negative allosteric modulator for major depressive disorder (MDD), aiming for efficacy similar to Spravato but with fewer side effects. Phase 2 data expected by late 2025 [10][11] - The study involves 72 patients, focusing on changes in MADRS scores by day five [11][12] - **Osavampator**: An AMPA potentiator with positive phase 2 data, showing significant efficacy and a favorable safety profile. Phase 3 trials are ongoing, with data expected in 2027 [16][19] - The most effective dose showed a MADRS effect size of 0.55 to 0.75, indicating strong efficacy [19][20] - **NBI-568**: A treatment for schizophrenia, with phase 2 results showing a significant improvement in PANSS scores. The best-performing dose was 20 mg once daily, with a placebo-corrected improvement of 7.5 points and an effect size of 0.61 [35][37] Market Performance and Financials - In Q2, Neurocrine reported $682 million in revenue, a 17% year-over-year growth, driven by Ingrezza and CRENESSITY [54][55] - Ingrezza achieved record back-to-back NRX quarters and a record TRX quarter in Q2, indicating strong market performance [54] Future Outlook - The company is optimistic about its evolving R&D strategy and the potential of its pipeline to address significant unmet needs in neuropsychiatric conditions [6][55] - The focus on validated biological pathways and diverse mechanisms of action aims to enhance treatment options for patients with major depressive disorder and schizophrenia [27][50] Additional Insights - The company emphasizes the importance of safety and tolerability in its drug development, particularly for chronic psychiatric conditions [50] - Neurocrine's approach to managing clinical trials aims to simplify processes and enhance the likelihood of positive outcomes, learning from past industry experiences [43][45] This summary encapsulates the key discussions and insights from the Neurocrine Biosciences FY Conference Call, highlighting the company's strategic direction, pipeline developments, and market performance.