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 ...

文章核心观点 - 公司宣布其神经科学药物NBI-1117568(NBI-'568)在成人精神分裂症患者的II期临床试验中取得积极的初步结果 [1][2][3] - NBI-'568是首个口服、选择性M4受体激动剂,这是一种创新的精神分裂症治疗方法 [1] - 20mg剂量组在6周时PANSS评分较基线下降18.2分,优于安慰剂组的10.8分降幅,差异有统计学意义 [2][3] - 但其他3个较高剂量组(30mg、40mg、60mg)未达到统计学显著性 [4] - 该结果与百时美施贵宝公司收购的Karuna公司的KarXT疗效相当,但优于安慰剂的改善幅度略低于KarXT III期试验 [5][6] - 与AbbVie公司(前Cerevel公司)的ABBV emraclidine相比,NBI-'568的优于安慰剂的改善幅度也略低 [6] - 但本试验中安慰剂组的改善幅度较之前KarXT和emraclidine的II期试验更大,这可能与对这一新机制疗法的预期偏差有关 [7]

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 ...

Investors seek growth stocks to capitalize on above-average growth in financials that help these securities grab the market's attention and produce exceptional returns. But finding a growth stock that can live up to its true potential can be a tough task. In addition to volatility, these stocks carry above-average risk by their very nature. Also, one could end up losing from a stock whose growth story is actually over or nearing its end. However, the task of finding cutting-edge growth stocks is made easy w ...

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, ...

财务数据和关键指标变化 - 2024年第二季度INGREZZA销售额为5.8亿美元,同比增长32% [13] - 公司提高了2024年INGREZZA全年销售指引,调整至22.5亿-23亿美元,之前为21亿-22亿美元 [13] - 公司预计2025年销售和营销费用将增加1.25亿美元,以支持INGREZZA和Crinecerfont的增长 [15] 各条业务线数据和关键指标变化 - INGREZZA在精神病学、神经学和长期护理等领域的销售均保持良好增长 [62] - 公司将在第四季度增加精神病学和长期护理销售团队规模,以加快INGREZZA的诊断和治疗 [21] - 公司推出了INGREZZA喷雾剂型,为吞咽困难的患者提供新的给药选择 [22][23] 各个市场数据和关键指标变化 - 公司估计目前仍有80%的TD患者未接受VMAT2抑制剂治疗,市场机会依然很大 [127] - 公司将继续投资INGREZZA,因为相信仍有很大的增长空间 [55][56][57] 公司战略和发展方向及行业竞争 - 公司将继续探索INGREZZA在其他适应症如运动障碍和精神分裂症的应用,并开发新一代VMAT2抑制剂 [11] - 公司有最广泛的神经科学管线,未来将更多关注自主研发,从症状改善向疾病修饰和治愈性疗法转变 [78] - 公司有望在2025年推出Crinecerfont,这将改变CAH治疗范式 [12][32] 管理层对经营环境和未来前景的评论 - 公司相信INGREZZA仍有很大增长空间,每次扩大销售团队都能带来积极影响 [10][55][56][57] - 公司对Crinecerfont在CAH治疗中的前景感到兴奋,将与FDA密切合作推进审评 [32] - 公司管线中有多个有前景的新药,包括AMPA调节剂和选择性肌素M4激动剂,将继续大幅投入研发 [30][34][35] 其他重要信息 - 公司将迎来新任CEO Kyle Gano,他对公司未来发展充满信心 [71][72][73][74][75][76][77][78] - 公司有1.7亿美元的现金,财务状况良好,有能力推进管线发展 [80] 问答环节重要的提问和回答 问题1 **Philip Nadeau 提问** 对于M4激动剂NBI-568,公司是否可以分享一些健康受试者研究的数据,了解药物的肌素副作用、心血管影响和靶点亲和力等信息 [40] **Eiry Roberts 回答** 公司将在本季度公布NBI-568 II期试验的结果,包括PANSS评分变化、安慰剂校正PANSS评分变化、效应量以及安全性和耐受性指标 [41][42][43] 问题2 **Paul Matteis 提问** 对于NBI-568,公司如何看待疗效目标,如PANSS评分改善幅度,以及剂量方案(QD vs BID)和胃肠道不良反应等其他产品特征 [49][50][51] **Eiry Roberts 回答** 公司希望看到PANSS评分改善幅度在8分左右或更高,同时也关注整体获益风险情况,包括耐受性情况。公司之前在I期试验中评估了QD和BID给药方案 [51][52][53] 问题3 **Tazeen Ahmad 提问** INGREZZA销售持续超预期,为何还需要扩大销售团队 [55] **Eric Benevich和Matthew Abernethy回答** 公司相信仍有大量未诊断和未接受VMAT2抑制剂治疗的TD患者,扩大销售团队有助于进一步提高INGREZZA的诊断和使用率,带来良好的投资回报 [56][57][58][59]