Biohaven is close to filing a new drug application for troriluzole, a potential treatment for spinocerebellar ataxia (SCA), a rare neurodegenerative disorder with no approved therapies. Despite setbacks, including a failed Phase 3 study in SCA, Biohaven worked with the FDA to design a new study using real-world evidence. Preliminary results show troriluzole slowed disease progression by 50-70% over three years compared to untreated patients. Based on these positive results, Biohaven plans to seek FDA approval for troriluzole as a treatment for all SCA types. Analysts have mixed reactions, with some seeing potential benefits and others expressing regulatory concerns.
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Real-World Data Salvage Biohaven Drug, Paving Way for FDA Filing in Neuro Disease With No Approved Meds
