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 Bios ...

The company promises to advance a top investigational drug to late-stage testing, but investors might not think that's a fine idea. Neurocrine Biosciences (NBIX 3.77%) had some major news to report several days ago, but it was hardly beneficial to the company's stock. The latest information from the lab dampened enthusiasm for the company, sending its share price down by 16% week to date as of early Friday morning, according to data compiled by S&P Global Market Intelligence. One clear success out of four B ...

Wednesday, Neurocrine Biosciences, Inc. (NASDAQ: NBIX) topline data for its Phase 2 clinical study of NBI1117568 (NBI-'568) in adults with schizophrenia. The new data showed that the once-daily 20 mg dose of NBI-'568 induced an average 18.2-point reduction from baseline in the Positive and Negative Syndrome Scale (PANSS) after six weeks, compared to 10.8 points in the placebo group. That 7.5-point difference reached statistical significance with a p-value of p=0.011. The company noted that none of the other ...

Shares of Neurocrine Biosciences (NBIX) were down nearly 19% on Tuesday after it reported top-line data from a phase II study on its investigational oral drug NBI-1117568 (NBI-'568) in adults with schizophrenia. The drug is being developed in partnership with Nxera Pharma (formerly Sosei Heptares). NBIX Reports Mixed Results The study met its primary endpoint — treatment with a 20 mg dose of NBI-'568 achieved a statistically significant and clinically meaningful 7.5-point reduction in the Positive and Negat ...

Morgan Stanley 22nd Annual Global Healthcare Conference on September 4 in New York 2024 Wells Fargo Healthcare Conference on September 5 in Boston SAN DIEGO, Aug. 28, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) will present at two upcoming investor conferences in September. Chief Executive Officer Kevin Gorman, Chief Business Development and Strategy Officer Kyle Gano, and Chief Financial Officer Matt Abernethy will present at the Morgan Stanley 22nd Annual Global Healthcare Conference ...

Core Insights - Neurocrine Biosciences, Inc. reported topline data from its Phase 2 clinical study of NBI-1117568, an oral muscarinic M4 selective agonist for schizophrenia, showing a significant reduction in PANSS scores compared to placebo [1] - The 20 mg dose of NBI-1117568 resulted in an 18.2-point reduction in PANSS after six weeks, while the placebo group showed a 10.8-point reduction, with a statistically significant difference of 7.5 points (p=0.011) [1][2] - Other higher dosing groups (30, 40, and 60 mg) did not achieve statistical significance [2] Comparative Analysis - The effect size of NBI-1117568 is comparable to Bristol Myers Squibb's KarXT, but the 7.5-point delta versus placebo is lower than the 11.6-point difference observed in the Phase 3 EMERGENT-2 study [3] - The placebo improvement of 10.8 points is higher than previous Phase II studies of KarXT and emraclidine, indicating potential expectation bias due to a more validated mechanism [4] Market Reaction - Following the announcement, Neurocrine Biosciences' stock price decreased by 18.90%, trading at $123.71 [4]

The Once-Daily 20 mg Dose Met the Primary Endpoint, Demonstrating a Statistically Significant 7.5-Point Improvement (p=0.011, 0.61 Effect Size) in the PANSS Total Score Compared to Placebo at Week 6 with an 18.2-Point PANSS Total Score Improvement from Baseline The Once-Daily 20 mg Dose Met Additional Endpoints, Demonstrating Statistically Significant Improvements in Clinical Global Impression of Severity Scale and Marder Factor Score Positive Symptom Change and Negative Symptom Change NBI-'568 Was Generall ...

SAN DIEGO, Aug. 7, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) will present at the Canaccord Genuity 44th Annual Growth Conference in Boston at 3:30 p.m. Eastern Time on Wednesday, August 14, 2024. Kyle Gano, Chief Business Development and Strategy Officer, and Todd Tushla, Vice President of Investor Relations, will present at the conference. The live presentation will be webcast and may be accessed on Neurocrine Biosciences' website under Investors at www.neurocrine.com. A replay of th ...

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koto_feja The arrow is pointing up these days for Neurocrine Biosciences (NASDAQ:NBIX) as this neuro- and neuropsych-focused biotech continues to report healthy sales of its core commercial product Ingrezza, while also delivering clinical wins and a deepening pipeline of high-potential drugs. Neurocrine shares are up about 15% since my last update, which is a little better than the overall biotech sector over that time period. With healthy sales growth from Ingrezza, a likely launch of crinecerfont in 2025, ...