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 ...

INGREZZA was generally well tolerated over the long term, and TEAEs observed in the study were consistent with its established safety profile and with known symptoms of Huntington's disease:Â Additional presentations at the 2025 MDS International Congress of Parkinson's Disease and Movement Disorders include: , /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today presented new data from the open-label KINECT-HD2 study demonstrating an established long-term safety profile, tolerability and susta ...

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.

Core Insights - Neurocrine Biosciences, Inc. will present new data from the Phase 2 SAVITRI study of osavampator for adults with major depressive disorder at Psych Congress 2025 [1] Group 1 - The SAVITRI study's top-line results were initially announced in April 2024 [1] - The poster presentation has been selected as a finalist for the Psych Congress Poster Awards [1] - The event will take place from September 17-21, 2025, in San Diego [1]