Workflow
神经分泌生物科学(NBIX)
icon
搜索文档
Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating Effects of NBI-1117567 in Healthy Adults
Prnewswire· 2024-05-08 20:30
SAN DIEGO, May 8, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced the initiation of its Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1117567 in healthy adult participants. NBI-1117567 is an investigational, oral, M1/M4 (M1 preferring) selective muscarinic agonist for the potential treatment of neurological and neuropsychiatric conditions. "Neurocrine Biosciences has the lar ...
Neurocrine Biosciences Supports Tardive Dyskinesia Awareness Week by Advocating for Routine Screening and Monitoring
Prnewswire· 2024-05-06 20:30
Approximately 600,000 people in the United States live with tardive dyskinesia (TD), and about 65% have not yet been diagnosed1-3 The diagnosis rate can be improved by increasing routine TD screenings in people treated with antipsychotic medication4   SAN DIEGO, May 6, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today renewed its commitment to increasing awareness and advancing care for people living with TD during Tardive Dyskinesia Awareness Week, May 5-11. TD is a persistent, invol ...
Neurocrine Biosciences Presented CAHtalyst™ Pediatric Study Baseline Characteristics and CAHtalog™ Registry Data at PES 2024
Prnewswire· 2024-05-04 01:15
CAHtalyst™ Pediatric Study Baseline Characteristics Data Highlight Need for Novel Treatments in Children and Adolescents with Congenital Adrenal Hyperplasia (CAH) CAHtalog™ Registry Data of Glucocorticoid Treatment Patterns in Pediatric and Adult Patients Illustrates the Challenges of Long-Term CAH Management SAN DIEGO, May 3, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today presented the CAHtalyst™ Pediatric Phase 3 clinical study baseline characteristics data for children and ado ...
Neurocrine(NBIX) - 2024 Q1 - Earnings Call Transcript
2024-05-02 00:38
财务数据和关键指标变化 - 第一季度销售额为5.06亿美元,同比增长23%,连续第三个季度实现环比增长 [1][2] - 公司在非GAAP基础上实现了超过1000个基点的营业利润率提升,反映了INGREZZA业务的强劲表现 [2] - 公司现金余额达19亿美元,为未来发展提供了充足的资金支持 [2] 各条业务线数据和关键指标变化 - INGREZZA在精神病科、神经科和长期护理三大业务线均实现了良好增长 [6] - INGREZZA在长期护理领域的贡献与神经科业务相当,仍有较大的增长空间 [14] 各个市场数据和关键指标变化 - 公司获批推出INGREZZA喷雾剂新剂型,预计将为吞咽困难的TD和亨廷顿舞蹈患者提供新的治疗选择 [3][6] 公司战略和发展方向及行业竞争 - 公司正在积极推进Crinecerfont的商业化准备,并计划在2025年推出该产品 [6] - 公司研发管线包括多个针对精神疾病的新药候选,如AMPA受体调节剂NBI-845和NMDA受体调节剂NBI-770等,展现了公司在中枢神经系统疾病领域的研发实力 [3][7][9] - 公司正在与Voyager合作开发基因疗法,利用Voyager的新型病毒载体技术,有望实现单次静脉给药治疗中枢神经系统和外周症状 [8] 管理层对经营环境和未来前景的评论 - 公司CEO表示,公司从商业到临床各方面发展都处于最佳状态,未来发展前景看好 [16] - 公司将继续优化资源配置,聚焦最有前景的研发项目,确保公司长期可持续发展 [16] 问答环节重要的提问和回答 问题1 **分析师提问** 对于NBI-845的剂量反应情况,公司是否有更多信息可以分享?[5] **公司回应** 公司目前不方便透露具体剂量信息,但整体数据显示该药物在疗效和安全性方面表现良好,公司将与FDA进一步讨论临床开发计划 [5] 问题2 **分析师提问** 公司对于未来几年内可能启动的多个III期临床试验的执行能力有何评估?[13] **公司回应** 公司将根据各项目的数据情况进行优先排序和资源配置,确保关键项目的顺利推进。公司有充足的资金实力支持管线的发展 [13] 问题3 **分析师提问** 对于即将公布的Luvadaxistat III期试验数据,公司期望看到什么样的疗效结果才会决定继续推进?[11] **公司回应** 之前Luvadaxistat II期试验就已显示在改善精神分裂症患者认知功能方面有积极作用,III期试验的目标是进一步验证并量化这一疗效,如果结果令人满意,公司将推进III期开发 [11]
Neurocrine (NBIX) Reports Q1 Earnings: What Key Metrics Have to Say
Zacks Investment Research· 2024-05-01 22:35
Neurocrine Biosciences (NBIX) reported $515.3 million in revenue for the quarter ended March 2024, representing a year-over-year increase of 22.6%. EPS of $0.42 for the same period compares to -$0.79 a year ago.The reported revenue compares to the Zacks Consensus Estimate of $512.21 million, representing a surprise of +0.60%. The company delivered an EPS surprise of -59.62%, with the consensus EPS estimate being $1.04.While investors closely watch year-over-year changes in headline numbers -- revenue and ea ...
Neurocrine Biosciences (NBIX) Q1 Earnings Miss Estimates
Zacks Investment Research· 2024-05-01 21:15
Neurocrine Biosciences (NBIX) came out with quarterly earnings of $0.42 per share, missing the Zacks Consensus Estimate of $1.04 per share. This compares to loss of $0.79 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -59.62%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $1.13 per share when it actually produced earnings of $1.44, delivering a surprise of 27.43%.Over the last four ...
Neurocrine(NBIX) - 2024 Q1 - Quarterly Report
2024-05-01 19:03
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 0-22705 NEUROCRINE BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction o ...
Neurocrine(NBIX) - 2024 Q1 - Quarterly Results
2024-05-01 19:01
Exhibit 99.1 Neurocrine Biosciences Reports First Quarter 2024 Financial Results INGREZZA® (valbenazine) First Quarter Net Product Sales of $506 Million Representing 23% Year-Over- Year Growth INGREZZA® SPRINKLE (valbenazine) Capsules Approved by the U.S. FDA Crinecerfont New Drug Applications for the Treatment of Congenital Adrenal Hyperplasia Submitted to the U.S. FDA Positive Phase 2 Top-Line Data for NBI-1065845, a Potential First-In-Class AMPA Positive Allosteric Modulator, in Adults with Major Depress ...
Neurocrine Biosciences Announces U.S. FDA Approval of INGREZZA® SPRINKLE (valbenazine) Capsules
Prnewswire· 2024-05-01 05:12
SAN DIEGO, April 30, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration has approved INGREZZA® SPRINKLE (valbenazine) capsules, a new oral granules formulation of INGREZZA® (valbenazine) capsules prescribed for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease.1 INGREZZA SPRINKLE provides an alternative administration option for those who experience dysphagia or have difficulty swallowing. Like ...
Curious about Neurocrine (NBIX) Q1 Performance? Explore Wall Street Estimates for Key Metrics
Zacks Investment Research· 2024-04-30 22:20
Wall Street analysts forecast that Neurocrine Biosciences (NBIX) will report quarterly earnings of $1.04 per share in its upcoming release, pointing to a year-over-year increase of 231.7%. It is anticipated that revenues will amount to $512.21 million, exhibiting an increase of 21.8% compared to the year-ago quarter.Over the past 30 days, the consensus EPS estimate for the quarter has been adjusted downward by 3.8% to its current level. This demonstrates the covering analysts' collective reassessment of the ...