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Neurocrine Biosciences展示了新的 KINECT®-HD数据,显示 INGREZZA®(valbenazine)胶囊在身体各区域显著减少了舞蹈病症状

Neurocrine Biosciences Presents New KINECT®-HD Data Showing Significant Reduction in Chorea Across Body Regions With INGREZZA® (valbenazine) Capsules

CISION 等信源发布 2025-03-17 20:30

可切换为仅中文


Data Reinforce the Clinically Meaningful Impact of INGREZZA in Adults with Huntington's Disease Chorea

数据证实 INGREZZA 对亨廷顿病舞蹈症成人患者具有临床意义的重大影响

Findings Presented at the 2025 American Association of Neuroscience Nurses Neuroscience Advanced Practice Provider Symposium

2025年美国神经科学护士协会神经科学高级实践提供者研讨会展示的发现

SAN DIEGO

圣地亚哥

,

March 17, 2025

2025年3月17日

/PRNewswire/ --

/PRNewswire/ --

Neurocrine Biosciences, Inc.

神经内分泌生物科学公司

(Nasdaq:

(纳斯达克:

NBIX

NBIX

) presented data from the KINECT

)展示了来自KINECT的数据

®

®

-HD study showcasing significant improvements in chorea across body regions with once-daily

-HD研究展示了一天一次显著改善了身体各区域的舞蹈症症状

INGREZZA

英瑞扎

®

®

(valbenazine) capsules

缬苯那嗪胶囊

in adults with Huntington's disease. The post-hoc analysis was presented at the Neuroscience Advanced Practice Provider Symposium hosted by the American Association of Neuroscience Nurses in

在患有亨廷顿病的成人中。这项事后分析在由美国神经科学护士协会主办的神经科学高级实践提供者研讨会上发表。

New Orleans

新奥尔良

.

'This analysis reinforces the primary study findings, showing the consistent benefit of INGREZZA in reducing the involuntary movements of chorea that can affect any part of the body,' said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. 'Notably, the most significant improvements were seen in the arms and legs, which were the most severely affected at baseline.

“这项分析证实了主要研究结果,显示了INGREZZA在减少不自主的舞蹈样动作(可能影响身体任何部位)方面的一致益处,”Neurocrine Biosciences首席医学官Eiry W. Roberts博士说道。“值得注意的是,最显著的改善出现在手臂和腿部,这些部位在基线时受影响最为严重。”

These results are meaningful because they show how INGREZZA alleviates chorea symptoms and therefore helps people with Huntington's disease in their everyday lives.'.

这些结果很有意义,因为它们展示了 INGREZZA 如何缓解舞蹈症症状,从而帮助亨廷顿病患者在日常生活中更好地生活。

In the 12-week, Phase 3 KINECT-HD clinical trial, once-daily INGREZZA demonstrated a significant reduction in chorea severity, as measured by the Unified Huntington's Disease Rating Scale (UHDRS

在为期12周的第三阶段KINECT-HD临床试验中,每日一次的INGREZZA显著减轻了舞蹈样动作的严重程度,这一结果通过统一亨廷顿病评定量表(UHDRS)进行测量。

®

®

) Total Maximal Chorea (TMC) score, which measures chorea in seven body regions (face, buccal-oral-lingual region, trunk, right and left upper extremities, right and left lower extremities). This post-hoc analysis was conducted to assess the effect of INGREZZA on chorea by individual body region.

总最大舞蹈病(TMC)评分,该评分测量七个身体区域的舞蹈病(面部、口颊舌部、躯干、左右上肢、左右下肢)。此项事后分析旨在评估INGREZZA对各个身体区域舞蹈病的影响。

In the KINECT-HD study, patients were randomized 1:1 to receive INGREZZA (n=64)

在KINECT-HD研究中,患者被随机分为1:1接受INGREZZA(n=64)

at doses of 40 mg, 60 mg or 80 mg, or placebo (n=61).

剂量为40毫克、60毫克或80毫克,或安慰剂(n=61)。

TMC scores at baseline were similar between treatment groups. Key findings from the post-hoc analysis include:

TMC在基线时的得分在治疗组之间相似。事后分析的主要发现包括:

More participants had potentially meaningful chorea improvements (a TMC score shift from ≥2 at screening/baseline to ≤1 at maintenance) with INGREZZA versus placebo for all affected body regions.

与安慰剂相比,更多参与者在所有受影响的身体区域通过INGREZZA治疗后,舞蹈样动作有潜在显著改善(TMC评分从筛查/基线时的≥2降至维持期的≤1)。

Statistically significant chorea improvements were observed for the upper and lower extremities (

统计学上显著的舞蹈病改善见于上肢和下肢 (

P

P

<0.05

小于0.05

for each) – body regions with the highest chorea severity seen at baseline.

对于每个)- 在基线时观察到舞蹈病最严重的身体区域。

Average TMC body region scores improved at maintenance, with numerically greater improvements for all TMC items with INGREZZA versus placebo.

平均TMC身体区域评分在维持期有所改善,所有TMC项目使用INGREZZA后的数值改善均优于安慰剂。

About Chorea Associated with Huntington's Disease

关于与亨廷顿病相关的舞蹈症

Huntington's disease (HD) is a hereditary progressive neurodegenerative disorder in which the loss of certain neurons within the brain causes motor, cognitive and psychiatric symptoms. Symptoms generally appear between the ages of 30 and 50 years and worsen over a 10- to 25-year period. Most people with HD experience chorea, an abnormal involuntary movement disorder, characterized by irregular and unpredictable movements.

亨廷顿病 (HD) 是一种遗传性进行性神经退行性疾病,大脑内某些神经元的丧失会导致运动、认知和精神症状。症状通常在 30 至 50 岁之间出现,并在 10 到 25 年的时间内逐渐恶化。大多数 HD 患者会出现舞蹈症,这是一种异常的不自主运动障碍,其特征是不规则且不可预测的运动。

Chorea can affect various body parts and interfere with motor coordination, gait, swallowing and speech. HD is estimated to affect approximately 41,000 adults in the U.S., with more than 200,000 at risk of inheriting the disease..

舞蹈病可以影响身体的各个部位,并干扰运动协调、步态、吞咽和言语。据估计,美国约有41,000名成年人患有亨廷顿病(HD),并且超过20万人面临遗传该疾病的风险。

About KINECT

关于KINECT

®

®

-HD

-HD

KINECT

Kinect

®

®

-HD was a Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of valbenazine as a once-daily treatment to reduce chorea associated with Huntington's disease (HD) and evaluate the safety and tolerability of valbenazine in patients with HD. The study enrolled 128 adults 18 to 75 years of age who were diagnosed with motor-manifest HD and who had sufficient chorea symptoms to meet study protocol criteria..

-HD 是一项 III 期、随机、双盲、安慰剂对照研究,旨在评估 valbenazine 作为每日一次治疗减少与亨廷顿病 (HD) 相关的舞蹈症的疗效,并评估 valbenazine 在 HD 患者中的安全性和耐受性。该研究招募了 128 名 18 至 75 岁的成年人,这些患者被诊断为运动症状明显的 HD,并且具有足够的舞蹈症症状以符合研究方案的标准。

KINECT-HD used the Unified Huntington's Disease Rating Scale (UHDRS

KINECT-HD 使用了统一的亨廷顿病评定量表 (UHDRS)

®

®

) Total Maximal Chorea (TMC) score as the primary efficacy endpoint. The secondary endpoints included Clinical Global Impression of Change (CGI-C) response status and Patient Global Impression of Change (PGI-C) response status for valbenazine treatment. Treatment with valbenazine resulted in a placebo-adjusted mean reduction in the TMC score of 3.2 units (.

) 总最大舞蹈病 (TMC) 评分作为主要疗效终点。次要终点包括临床整体印象变化 (CGI-C) 反应状态和患者整体印象变化 (PGI-C) 反应状态,用于评估 valbenazine 的治疗效果。使用 valbenazine 治疗使 TMC 评分相对安慰剂组平均减少了 3.2 个单位 (。

P

P

<0.0001),

<0.0001),

indicating a substantial improvement in chorea. Secondary endpoints of CGI-C response status and PGI-C response status were also statistically significant and supported the improvements in TMC score that were seen over the 12-week study period.

表明舞蹈病有显著改善。CGI-C反应状态和PGI-C反应状态的次要终点也具有统计学意义,并支持了在12周研究期间观察到的TMC评分的改善。

Treatment-emergent adverse events in this study were generally consistent with the known safety profile of valbenazine. The most common adverse reactions in patients with HD included somnolence and sedation, urticaria, rash and insomnia.

本研究中出现的治疗相关不良事件与缬苯那嗪已知的安全性特征基本一致。亨廷顿病患者最常见的不良反应包括嗜睡和镇静、荨麻疹、皮疹和失眠。

View the complete study results from the Phase 3 KINECT-HD study published in

查看发表在《第三阶段KINECT-HD研究》的完整研究结果

The Lancet Neurology

《柳叶刀神经学》

online edition

在线版

. For more information on the KINECT-HD study, please visit

如需更多关于KINECT-HD研究的信息,请访问

HuntingtonStudyGroup.org

亨廷顿研究组.org

.

About INGREZZA

关于INGREZZA

®

®

(valbenazine) Capsules and INGREZZA

(valbenazine) 胶囊和INGREZZA

®

®

SPRINKLE (valbenazine) Capsules

洒落(valbenazine)胶囊

INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD). Only INGREZZA offers a therapeutic dose from day one with no required titration..

INGREZZA 是一种选择性囊泡单胺转运体 2 (VMAT2) 抑制剂,获美国食品药品监督管理局批准用于治疗成人迟发性运动障碍以及与亨廷顿病 (HD) 相关的舞蹈症。唯有 INGREZZA 可从第一天起提供治疗剂量,且无需调整剂量。

INGREZZA, developed by Neurocrine Biosciences, selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. While the specific way INGREZZA works to treat TD and HD chorea is not fully understood, INGREZZA is unique in that it selectively and specifically targets VMAT2 to inhibit the release of dopamine, a chemical in the brain that helps control movement.

INGREZZA由Neurocrine Biosciences开发,选择性抑制VMAT2,对VMAT1、多巴胺能(包括D2)、血清素能、肾上腺素能、组胺能或毒蕈碱受体没有明显的结合亲和力。尽管INGREZZA治疗TD和HD舞蹈症的具体机制尚未完全了解,但它的独特之处在于选择性且特异性地靶向VMAT2,以抑制多巴胺的释放。多巴胺是一种帮助控制大脑运动的化学物质。

INGREZZA is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements..

INGREZZA被认为可以减少过多的多巴胺信号传导,这可能会导致更少的无法控制的运动。

INGREZZA is proven across the widest range of patients. It is always one capsule, once daily and can be taken together with most stable mental health regimens such as antipsychotics or antidepressants. Only INGREZZA offers the benefit of a sprinkle formulation, INGREZZA

INGREZZA在最广泛的患者群体中得到了验证。它始终是每日一次,每次一粒胶囊,并且可以与大多数稳定的精神健康治疗方案(如抗精神病药物或抗抑郁药物)一起服用。只有INGREZZA提供了撒剂型的优势。

®

®

SPRINKLE, for those who experience dysphagia, have difficulty swallowing or prefer not to swallow a pill. INGREZZA and INGREZZA SPRINKLE dosages approved for use are 40 mg, 60 mg and 80 mg capsules.

对于那些经历吞咽困难或不喜欢吞咽药丸的人来说,可以选择使用INGREZZA SPRINKLE。已批准使用的INGREZZA和INGREZZA SPRINKLE剂量为40毫克、60毫克和80毫克的胶囊。

Important Information

重要信息

Approved Uses

批准的用途

INGREZZA

INGREZZA

®

®

(valbenazine) capsules or INGREZZA

(valbenazine) 胶囊或 INGREZZA

®

®

SPRINKLE (valbenazine) capsules are prescription medicines used to treat adults with:

SPRINKLE(缬苯那嗪)胶囊是用于治疗成年人的处方药:

movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).

面部、舌头或其他身体部位无法控制的动作(迟发性运动障碍)。

involuntary movements (chorea) of Huntington's disease. INGREZZA or INGREZZA SPRINKLE do not cure the cause of involuntary movements, and do not treat other symptoms of Huntington's disease, such as problems with thinking or emotions.

亨廷顿病的不自主运动(舞蹈症)。INGREZZA 或 INGREZZA SPRINKLE 不能治愈不自主运动的病因,也不能治疗亨廷顿病的其他症状,例如思维或情绪问题。

It is not known if INGREZZA or INGREZZA SPRINKLE is safe and effective in children.

不知道INGREZZA或INGREZZA SPRINKLE在儿童中是否安全有效。

IMPORTANT SAFETY INFORMATION

重要安全信息

INGREZZA or INGREZZA SPRINKLE can cause serious side effects in people with Huntington's disease, including: depression, suicidal thoughts, or suicidal actions.

INGREZZA 或 INGREZZA SPRINKLE 可能对亨廷顿病患者造成严重副作用,包括:抑郁、自杀念头或自杀行为。

Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington's disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.

在开始服用INGREZZA或INGREZZA SPRINKLE之前,请告知您的医疗保健提供者您是否患有亨廷顿病并感到抑郁(有未经治疗的抑郁或药物控制不佳的抑郁)或有自杀念头。密切注意任何变化,尤其是情绪、行为、思想或感觉方面的突然变化。

This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself..

这一点在开始使用INGREZZA或INGREZZA SPRINKLE以及调整剂量时尤为重要。如果您感到抑郁、情绪或行为有异常变化,或者有伤害自己的想法,请立即联系您的医疗保健提供者。

Do not take INGREZZA or INGREZZA SPRINKLE if you:

如果您有以下情况,请勿服用INGREZZA或INGREZZA SPRINKLE:

are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE.

对缬苯那嗪或INGREZZA或INGREZZA SPRINKLE中的任何成分过敏。

INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including:

INGREZZA 或 INGREZZA SPRINKLE 可能引起严重副作用,包括:

Allergic reactions.

过敏反应。

Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema can happen after taking the first dose or after many doses of INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble with swallowing, or rash, including raised, itchy red areas on your skin (hives).

服用INGREZZA或INGREZZA SPRINKLE的第一剂或许多剂后,可能会发生过敏反应,包括导致突发性肿胀(称为血管性水肿)的过敏反应。过敏反应和血管性水肿的体征和症状包括:呼吸困难或气短、面部、嘴唇、眼睑、舌头、喉咙或皮肤其他部位的肿胀、吞咽困难,或出现皮疹,包括皮肤上隆起的、发痒的红色区域(荨麻疹)。

Swelling in the throat can be life-threatening and can lead to death. Stop taking INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room right away if you develop these signs and symptoms of allergic reactions and angioedema..

喉咙肿胀可能危及生命,并可能导致死亡。如果出现这些过敏反应和血管性水肿的体征和症状,请立即停止服用INGREZZA或INGREZZA SPRINKLE,并前往最近的急诊室。

Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation).

可能导致反应迟缓的嗜睡和疲劳(昏昏欲睡和镇静)。

Do not drive a car or operate dangerous machinery until you know how INGREZZA or INGREZZA SPRINKLE affects you. Drinking alcohol and taking other medicines may also cause sleepiness during treatment with INGREZZA or INGREZZA SPRINKLE.

在您了解INGREZZA或INGREZZA SPRINKLE对您的影响之前,请勿驾驶汽车或操作危险机械。在使用INGREZZA或INGREZZA SPRINKLE治疗期间,饮酒和服用其他药物也可能导致嗜睡。

Heart rhythm problems (QT prolongation).

心律问题(QT间期延长)。

INGREZZA or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT prolongation. You have a higher chance of getting QT prolongation if you also take certain other medicines during treatment with INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right away if you develop any signs or symptoms of QT prolongation, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting or feeling like you are going to faint..

INGREZZA 或 INGREZZA SPRINKLE 可能导致一种称为 QT 间期延长的心律问题。如果您在使用 INGREZZA 或 INGREZZA SPRINKLE 治疗期间同时服用某些其他药物,出现 QT 间期延长的风险会更高。如果您出现任何 QT 间期延长的迹象或症状,请立即告知您的医疗保健提供者,包括:心跳过快、过慢或不规则(心悸)、呼吸急促、头晕或头昏、昏厥或感觉即将昏厥。

Neuroleptic Malignant Syndrome (NMS).

神经阻滞剂恶性综合征 (NMS)。

NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat..

NMS是一种严重的疾病,可能会导致死亡。如果出现以下症状且没有其他明显原因,请立即联系医疗服务提供者或前往最近的急诊室:高烧、肌肉僵硬、思维障碍、脉搏或血压不规则、出汗增多、心跳非常快或不规律。

Parkinson-like symptoms.

帕金森样症状。

Symptoms include: body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls.

症状包括:身体僵硬、流口水、移动或行走困难、难以保持平衡、颤抖(震颤)或跌倒。

Before taking INGREZZA or INGREZZA SPRINKLE, tell your healthcare provider about all of your medical conditions including if you:

在服用INGREZZA或INGREZZA SPRINKLE之前,请告诉您的医疗保健提供者您的所有医疗状况,包括您是否:

have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

有肝脏或心脏问题,怀孕或计划怀孕,或者正在哺乳或计划哺乳。

Tell your healthcare provider about all the medicines you take,

告诉您的医疗保健提供者您所服用的所有药物,

including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure you tell all of your healthcare providers that you are taking INGREZZA or INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with certain other medicines may cause serious side effects. Especially tell your healthcare provider if you: take digoxin or take or have taken a monoamine oxidase inhibitor (MAOI) medicine.

包括处方药和非处方药、维生素以及草本补充剂。务必告知您的所有医疗保健提供者您正在服用INGREZZA或INGREZZA SPRINKLE。将INGREZZA或INGREZZA SPRINKLE与某些其他药物一起服用可能会导致严重的副作用。特别是如果您:服用地高辛或正在服用或曾经服用过单胺氧化酶抑制剂(MAOI)类药物,请务必告知您的医疗保健提供者。

You should not take INGREZZA or INGREZZA SPRINKLE if you are taking, or have stopped taking, a MAOI within the last 14 days..

您不应在过去的14天内服用或已停止服用MAOI的情况下使用INGREZZA或INGREZZA SPRINKLE。

The most common side effect of INGREZZA or INGREZZA SPRINKLE in people with tardive dyskinesia

INGREZZA或INGREZZA SPRINKLE在迟发性运动障碍患者中最常见的副作用

are

sleepiness and tiredness.

困倦和疲惫。

The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with chorea associated with Huntington's disease include

INGREZZA或INGREZZA SPRINKLE在治疗与亨廷顿病相关的舞蹈病患者中最常见的副作用包括

sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep.

嗜睡和疲倦,皮肤上出现隆起的发痒红斑(荨麻疹)、皮疹,以及难以入睡或保持睡眠。

These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at

这些并非 INGREZZA 或 INGREZZA SPRINKLE 的全部可能副作用。如需了解副作用的医疗建议,请咨询您的医生。我们鼓励您向 FDA 报告处方药的负面副作用。访问 MedWatch 网站:

www.fda.gov/medwatch

www.fda.gov/medwatch

or call

或打电话

1-800-FDA-1088.

1-800-FDA-1088。

Dosage Forms and Strengths:

剂型和规格:

INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules.

INGREZZA 和 INGREZZA SPRINKLE 有 40 毫克、60 毫克和 80 毫克的胶囊可供选择。

Please see full

请查看完整内容

Prescribing Information,

处方信息,

including Boxed Warning, and Medication Guide.

包括加框警告和药物指南。

About Neurocrine Biosciences, Inc.

关于Neurocrine Biosciences公司

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders.

Neurocrine Biosciences是一家领先的专注于神经科学的生物制药公司,拥有一个简单的使命:减轻有重大需求患者的痛苦。我们致力于为那些尚未得到充分关注的神经、神经内分泌和神经精神疾病患者发现和开发生命改变的治疗方法。

The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas.

公司多样化的产品组合包括FDA批准的治疗药物,适应症涵盖迟发性运动障碍、亨廷顿病相关的舞蹈症、经典先天性肾上腺皮质增生症、子宫内膜异位症*和子宫肌瘤*,同时在我们的核心治疗领域中还有多个处于中期至后期临床开发的化合物,形成了强大的研发管线。

For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit .

三十年来,我们运用自己对神经科学以及大脑和身体系统之间相互联系的独特见解来治疗复杂疾病。我们不懈地寻找药物以减轻衰弱性疾病和病症的负担,因为您值得拥有勇敢的科学。欲了解更多信息,请访问。

LinkedIn

领英

,

X

X

and

Facebook

脸书

. (*

. (*

in collaboration with AbbVie

与艾伯维合作

)

)

The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, KINECT and INGREZZA are registered trademarks of Neurocrine Biosciences, Inc.

神经内分泌生物科学标志、NEUROCRINE、你值得勇敢的科学、KINECT和INGREZZA是Neurocrine Biosciences公司的注册商标。

Forward-Looking Statements

前瞻性声明

In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from INGREZZA for the treatment of chorea associated with Huntington's disease (HD) and the value INGREZZA may bring to patients with chorea associated with HD.

本新闻稿除包含历史事实外,还包含涉及若干风险和不确定性的前瞻性陈述。这些陈述包括但不限于有关 INGREZZA 治疗亨廷顿病 (HD) 相关舞蹈症的潜在益处以及 INGREZZA 可能为 HD 相关舞蹈症患者带来的价值的陈述。

Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of INGREZZA for the treatment of chorea associated with HD; whether INGREZZA receives adequate reimbursement from third-party payors; the degree and pace of market uptake of INGREZZA for the treatment of chorea associated with HD; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA for the treatment of chorea associated with HD; risks associated with the Company's dependence on third parties for development and manufacturing activities related to INGREZZA for the treatment of chorea associated with HD, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for INGREZZA for the treatment of chorea associated with HD or other product candidates may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding INGREZZA for the treatment of chorea associated with HD; risks that post-approval INGREZZA commitments or requirements may be delayed; risks th.

可能导致实际结果与前瞻性陈述中所述或暗示的结果存在重大差异的因素包括但不限于以下几点:与Neurocrine Biosciences的业务和财务相关的风险和不确定性,以及与INGREZZA在治疗亨廷顿舞蹈症(HD)相关舞蹈病商业化过程中的风险和不确定性;INGREZZA是否能够从第三方支付方获得足够的报销;市场对INGREZZA用于治疗HD相关舞蹈病的接受程度和速度;与竞争产品及技术变革相关的风险和不确定性,这些可能限制对INGREZZA用于治疗HD相关舞蹈病的需求;公司依赖第三方进行与INGREZZA治疗HD相关舞蹈病有关的开发和制造活动所带来的风险,以及公司管理这些第三方的能力;与INGREZZA用于治疗HD相关舞蹈病或其他候选产品的额外监管提交可能不会发生或未能及时提交的风险;FDA或其他监管机构可能对INGREZZA用于治疗HD相关舞蹈病做出不利决定的风险;批准后INGREZZA的相关承诺或要求可能被延迟的风险;以及其他风险。

December 31

12月31日

, 2024. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.

,2024年。Neurocrine Biosciences 免责声明:除非法律要求,否则不承担更新本新闻稿中包含的声明的义务。

© 2025 Neurocrine Biosciences, Inc. All Rights Reserved. CP-VBZ-US- 0049   03/2025

© 2025 Neurocrine Biosciences, Inc. 保留所有权利。CP-VBZ-US-0049 03/2025

SOURCE Neurocrine Biosciences, Inc.

来源:Neurocrine Biosciences, Inc.

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