Monday, Biohaven Ltd. BHVN released topline results from pivotal Study BHV4157-206-RWE demonstrating the efficacy of troriluzole on the mean change from baseline in the f-SARA after three years of treatment.

周一，Biohaven Ltd.BHVN发布了关键研究BHV4157-206-RWE的topline结果，证明了三年治疗后曲利鲁唑对f-SARA基线平均变化的疗效。

The study achieved the primary endpoint and showed statistically significant improvements on the f-SARA at years 1 and 2.

该研究达到了主要终点，并在第1年和第2年显示了f-SARA的统计学显着改善。

Spinocerebellar Ataxia (SCA) is a rare neurodegenerative disease. It affects approximately 15,000 people in the U.S. and 24,000 in Europe and the U.K.

脊髓小脑共济失调（SCA）是一种罕见的神经退行性疾病。它影响了美国大约15000人。S、 欧洲和美国有24000人。。

Also Read: Biohaven Stock Stumbles As Protein-Degrading Drug Falls Short Of Expectations In Early-Stage Study.

另请阅读：Biohaven股票下跌，因为蛋白质降解药物在早期研究中未达到预期。

There are no FDA-approved treatments for SCA.

没有FDA批准的SCA治疗方法。

Data across multiple analyses demonstrate a robust and clinically meaningful slowing of disease progression in SCA patients.

多项分析的数据表明，SCA患者的疾病进展速度强劲且具有临床意义。

These treatment benefits translate into a 50-70% slower rate of decline compared to untreated patients. They represent a 1.5-2.2 years delay in disease progression over the three-year study period.

与未经治疗的患者相比，这些治疗益处转化为50-70%的下降速度。他们代表了三年研究期间疾病进展的1.5-2.2年延迟。

Disease progression showed an odds ratio (OR) of 4.1 for the untreated external control arm versus troriluzole-treated subjects.

未经治疗的外部对照组与曲利鲁唑治疗的受试者的疾病进展显示优势比（OR）为4.1。

The primary objective was to examine the treatment effects of troriluzole for up to three years.

主要目的是检查曲利鲁唑长达三年的治疗效果。

Troriluzole-treated patients demonstrated statistically significant and sustained benefits at years 1, 2 and 3 on the f-SARA compared to a rigorously matched natural history control.

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Biohaven plans to submit a New Drug Application (NDA) to the FDA in the fourth quarter of 2024.

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The troriluzole development program has generated the largest clinical trial dataset in SCA and now has a follow-up in some patients treated with troriluzole for over five years.

曲利鲁唑开发计划已经产生了SCA中最大的临床试验数据集，现在对一些接受曲利鲁唑治疗超过五年的患者进行了随访。

Biohaven will be prepared to commercialize SCA in the U.S. in 2025, if ultimately approved, based on potential priority review timelines.

如果最终获得批准，Biohaven将根据潜在的优先审查时间表，准备于2025年在美国将SCA商业化。

Price Action: Biohaven stock is up 12% at $45.20 during the premarket session at last check Monday.

价格走势：Biohaven股票在周一最后一次检查的上市前交易中上涨12%，收于45.20美元。

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