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A Phase IIb/III, Randomized, Double-blind, Placebo-controlled Trial of BHV-4157 Troriluzole in Adult Subjects With Spinocerebellar Ataxia

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Trial Profile

A Phase IIb/III, Randomized, Double-blind, Placebo-controlled Trial of BHV-4157 Troriluzole in Adult Subjects With Spinocerebellar Ataxia

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 20 May 2025

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At a glance

  • Drugs Troriluzole (Primary)
  • Indications Spinocerebellar ataxias
  • Focus Registrational; Therapeutic Use
  • Sponsors Biohaven Pharmaceutical Holding Company; Biohaven Pharmaceuticals

Most Recent Events

  • 14 May 2025 According to a Biohaven Pharmaceuticals media release, company announced that the Division of Neurology 1 within FDA's Office of Neuroscience informed the extending the PDUFA date for the troriluzole NDA for the treatment of SCA by 3 months to provide time for a full review of company recent submissions requests from the FDA. The Division also currently planning to hold an advisory committee meeting to discuss the application. The FDA's decision regarding the NDA is now expected in 4Q 2025.
  • 28 Apr 2025 According to a Biohaven Pharmaceuticals media release, company announced that it has entered into an agreement with Oberland Capital Management LLC (Oberland Capital) for an investment of up to $600 million in the Company. The additional capital provides significant financial resources for ongoing clinical trials and supports commercialization efforts in anticipation of a potential U.S. Food and Drug Administration (FDA) approval of troriluzole for the treatment of patients with SCA.
  • 03 Mar 2025 According to a Biohaven Pharmaceuticals media release, company is preparing for commercial launch in all-genotype SCA in 2025, following FDA filing acceptance and 3Q 2025 PDUFA date.

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