BOSTON--(BUSINESS WIRE)--Karuna Therapeutics, Inc. (NASDAQ: KRTX), a biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for KarXT (xanomeline-trospium) for the treatment of schizophrenia in adults.

BOSTON-（BUSINESS WIRE）-Karuna Therapeutics，Inc。（纳斯达克股票代码：KRTX），一家生物制药公司，致力于为患有精神和神经疾病的人发现，开发和提供转化药物，今天宣布，美国食品和药物管理局（FDA）已接受KarXT（xanomeline trospium）新药申请（NDA），用于治疗成人精神分裂症。

The application has been granted a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024..

该申请已获得2024年9月26日的处方药使用费法案（PDUFA）。。

“We are pleased the NDA for KarXT has been accepted, and we look forward to working with the FDA during the review process,” said Bill Meury, president and chief executive officer of Karuna Therapeutics. “There is a significant need for new treatment options for serious mental illness. If approved, KarXT could be one of the more important new product introductions in neuropsychiatry by providing a novel pharmacological approach for the treatment of schizophrenia.”.

Karuna Therapeutics总裁兼首席执行官Bill Meury说：“我们很高兴KarXT的NDA已被接受，我们期待在审核过程中与FDA合作。“严重精神疾病的新治疗方案迫切需要，如果获得批准，KarXT可能是神经精神病学中更重要的新产品推出之一，为精神分裂症的治疗提供了一种新的药理学方法。”。

“Schizophrenia’s disabling symptoms pose significant challenges to navigating crucial aspects of life, including developing relationships, maintaining employment, and securing safe housing,” said Gordon Lavigne, M.Ed., chief executive officer, Schizophrenia & Psychosis Action Alliance. “Diagnosis marks the beginning of an often long and tiresome search for effective and tolerable treatment options.

精神分裂症和精神病行动联盟首席执行官Gordon Lavigne博士说：“精神分裂症的致残症状对导航生活的关键方面构成重大挑战，包括发展关系，维持就业和确保安全住房。“诊断标志着寻找有效和可耐受的治疗方案的开始，往往是漫长而乏味的。

The nature and magnitude of side effects often play a pivotal role in whether someone continues treatment, which is often crucial to minimize the risk of relapse and realize the life-altering benefits of long-term treatment. Potential approval of a pharmacologically distinct treatment option would be a welcome innovation for people living with schizophrenia.”.

副作用的性质和程度通常在某人是否继续治疗中起关键作用，这对于最小化复发风险和实现长期治疗的改变生命的益处通常是至关重要的。对于精神分裂症患者来说，潜在批准药理学上独特的治疗方案将是一项受欢迎的创新。”。

The NDA submission is supported by efficacy and long-term safety data from the EMERGENT program, the clinical program evaluating KarXT as a treatment for schizophrenia. The EMERGENT program includes the three completed positive EMERGENT-1, EMERGENT-2, and EMERGENT-3 trials evaluating the efficacy and safety of KarXT compared to placebo, and the EMERGENT-4 and EMERGENT-5 trials evaluating the long-term safety of KarXT..

NDA的提交得到了来自EMERGENT计划的有效性和长期安全性数据的支持，该计划是评估KarXT治疗精神分裂症的临床计划。紧急计划包括评估KarXT与安慰剂相比疗效和安全性的三项完成的积极紧急-1，紧急-2和紧急-3试验，以及评估长期安全性的紧急-4和紧急-5试验。KarXT。。

In all three placebo-controlled trials, KarXT met its primary endpoint, demonstrating statistically significant and clinically meaningful improvements in symptoms of schizophrenia compared to placebo as measured by Positive and Negative Syndrome Scale (PANSS) total score. KarXT was found to be generally well tolerated, with the most common adverse events being cholinergic in nature and mild to moderate in severity.

在所有三项安慰剂对照试验中，KarXT均达到其主要终点，通过阳性和阴性症状量表（PANSS）总分测量，与安慰剂相比，精神分裂症症状有统计学意义和临床意义的改善。发现KarXT通常具有良好的耐受性，最常见的不良事件是胆碱能，严重程度为轻度至中度。

Notably, KarXT was not associated with common side effects of currently available antipsychotics, including weight gain, somnolence, and movement disorders..

值得注意的是，KarXT与目前可用的抗精神病药物的常见副作用无关，包括体重增加，嗜睡和运动障碍。。

“KarXT focuses on a novel pathway through muscarinic receptors to indirectly modulate dopamine signaling in key brain circuits, and in clinical trials completed to date KarXT has demonstrated the much-needed combination of strong tolerability and clinically meaningful symptom reduction,” remarked Rishi Kakar, M.D., chief scientific officer and medical director of Segal Trials, and investigator in the EMERGENT program.

“KarXT专注于通过毒蕈碱受体间接调节关键脑回路中多巴胺信号传导的新途径，并且在迄今为止完成的临床试验中，KarXT证明了强烈耐受性和临床上有意义的症状减轻之间急需的结合，”Segal试验首席科学官兼医疗总监Rishi Kakar说，和紧急计划的调查员。

“This decision by the FDA marks an important step in working toward a new chapter in the standard of care for those facing the immense, daily struggle of this serious mental illness.”.

“FDA的这一决定标志着朝着面对这种严重精神疾病的巨大日常斗争的人的护理标准迈出新的一步。”。

About KarXT

关于KarXT

KarXT (xanomeline-trospium) is an investigational muscarinic antipsychotic in development for the treatment of schizophrenia and psychosis related to Alzheimer’s disease. Through its novel mechanism of action, KarXT acts as a dual M1/M4 muscarinic acetylcholine receptor agonist in the central nervous system, which is thought to improve positive, negative, and cognitive symptoms of schizophrenia.

KarXT（xanomeline trospium）是一种研究性毒蕈碱类抗精神病药物，用于治疗与阿尔茨海默病相关的精神分裂症和精神病。通过其新的作用机制，KarXT在中枢神经系统中充当双重M1/M4毒蕈碱乙酰胆碱受体激动剂，被认为可改善精神分裂症的阳性，阴性和认知症状。

Unlike existing treatments, KarXT does not directly block dopamine receptors, representing a potential new approach to treating schizophrenia..

与现有治疗方法不同，KarXT不直接阻断多巴胺受体，代表了治疗精神分裂症的潜在新方法。。

About Schizophrenia

关于精神分裂症

Schizophrenia is a persistent and often disabling mental illness impacting how a person thinks, feels, and behaves, and affects nearly 24 million people worldwide, including 2.8 million people in the U.S. It is characterized by three symptom domains: positive symptoms (hallucinations and delusions), negative symptoms (difficulty enjoying life and withdrawal from others), and cognitive impairment (deficits in memory, concentration, and decision-making).

精神分裂症是一种持续且经常致残的精神疾病，会影响一个人的思考，感受和行为方式，并影响全球近2400万人，其中包括美国的280万人。它的特征是三个症状领域：阳性症状（幻觉和妄想），阴性症状（享受生活和退学困难），和认知障碍（记忆力，注意力和决策能力不足）。

In part due to limitations with current treatments, people living with schizophrenia often struggle to maintain employment, live independently, and manage relationships. While current treatments can be effective in managing select symptoms, approximately 30% of people do not respond to therapy, with an additional 50% experiencing only a partial improvement in symptoms or unacceptable side effects..

部分由于目前治疗的局限性，精神分裂症患者往往难以维持就业，独立生活和管理人际关系。虽然目前的治疗方法可以有效地控制某些症状，但大约30%的人对治疗没有反应，另外50%的人仅出现症状的部分改善或不可接受的副作用。。

About Karuna

关于卡鲁纳

Karuna Therapeutics is a biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions. At Karuna, we understand there is a need for differentiated and more effective treatments that can help patients navigate the challenges presented by serious mental illness.

Karuna Therapeutics是一家生物制药公司，致力于为患有精神病和神经疾病的人发现，开发和提供变革性药物。在卡鲁纳，我们了解需要有区别和更有效的治疗方法来帮助患者应对严重精神疾病带来的挑战。

Utilizing our extensive knowledge of neuroscience, we are harnessing the untapped potential of the brain in pursuit of novel pathways to develop medicines that make meaningful differences in peoples’ lives. For more information, please visit www.karunatx.com..

利用我们广泛的神经科学知识，我们正在利用大脑尚未开发的潜力，寻求新的途径来开发能够在人们生活中产生有意义差异的药物。欲了解更多信息，请访问www.karunatx.com。。

Forward-Looking Statements

前瞻性声明

This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our goals to develop and commercialize our product candidates, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms.

本新闻稿包含1933年“证券法”（经修订）第27A条和1934年“证券交易所法”（经修订）第21E条含义内的前瞻性声明，包括有关我们开发和商业化候选产品目标的声明，以及其他用“可以”，“期望”，“意图”，“可以”，“计划”，“潜力”，“应该”，“将会”或类似表达方式和这些术语的否定词标识的陈述。

Forward-looking statements are not promises or guarantees of future performance and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to obtain necessary funding, our ability to generate positive clinical trial results for our product candidates and other risks inherent in clinical development, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, risks relating to business interruptions, and other risks set forth under the heading “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2022 and in our subsequent filings with the Securities and Exchange Commission.

前瞻性声明不是对未来业绩的承诺或保证，并且受到各种风险和不确定性的影响，其中许多风险和不确定性是我们无法控制的，并且可能导致实际结果与此类前瞻性声明中预期的结果大不相同。这些因素包括与我们有限的运营历史相关的风险，我们获得必要资金的能力，我们为产品候选人产生积极临床试验结果的能力以及临床开发中固有的其他风险，监管审批的时间和范围，法律和我们所处法规的变化，竞争压力，我们能够确定额外的候选产品，与业务中断有关的风险以及我们在2022年12月31日结束的年度10-K表格年度报告“风险因素”标题下提出的其他风险，以及我们随后提交的文件证券交易所。

Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements..

我们的实际结果可能与此类前瞻性声明中描述或暗示的结果有很大不同。前瞻性声明仅在本声明签署之日起生效，除法律规定外，我们不承担更新或修改这些前瞻性声明的义务。。