Biohaven Achieves Positive Topline Results in Pivotal Study of ...

NEW HAVEN, Conn., Sept. 23, 2024 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), today announced positive topline results from pivotal Study BHV4157-206-RWE (NCT06529146) demonstrating the efficacy of troriluzole on the mean change from baseline in …

CouponFollow Extension

50%
OFF

Biohaven Stock Soars On Positive Results For Rare ... - Investopedia

1 week from now

Sep 23, 2024 · The study of the drug troriluzole found a 50% to 70% slower rate of decline over three years for patients with spinocerebellar ataxia (SCA). The news sent Biohaven shares …

investopedia.com

FAQs about Biohaven Achieves Positive Topline Results in Pivotal Study of ... Coupon?

What does Biohaven do?

Biohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. ...

Will Biohaven submit a new drug applica6on in Q4 2024?

Based upon the topline data from Study BHV4157-206-RWE, and previous safety and efficacy data from the troriluzole development program in SCA, Biohaven plans to submit a New Drug Applica6on (NDA) to the FDA in Q4 2024. ...

Will Biohaven be approved in the UK?

This new data should provide additional evidence on the benefit of the drug. Ataxia UK will be encouraging Biohaven to seek approval in the UK and we will share any information as soon as we have it. The results of this study will be presented at the International Congress for Ataxia Research (ICAR) in London in November. ...

Does Biohaven have a clinical trial program for troriluzole?

The troriluzole development program has generated the largest clinical trial dataset in SCA and now has follow-up in some patients treated with troriluzole for over 5 years. Biohaven has previously received both Fast-Track and Orphan drug designation (ODD) from the FDA, and ODD from the European Medicines Agency, for troriluzole in SCA. ...

When will Biohaven submit a New Drug Application (NDA)?

Will Biohaven submit a new drug applica6on for troriluzole in 4Q 2024?

Biohaven plans to submit a New Drug Applica6on (NDA) to the US Food and Drug Administra6on (FDA) for troriluzole in the treatment of all SCA genotypes in 4Q 2024. The applica6on is eligible for a priority review given orphan drug and fast-track designa6ons previously granted by FDA. ...