Biohaven tanks as FDA issues CRL for Vyglxia

6 November 2025

Shares of US clinical-stage biopharma Biohaven (NYSE: BHVN) plunged more than 40% to $8.34 yesterday, after it announced that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for the New Drug Application (NDA) seeking approval of Vyglxia (troriluzole) for the treatment of spinocerebellar ataxia (SCA).

SCA is a group of rare and ultra-rare progressively debilitating and fatal genetic conditions for which no specific treatments are currently available.

The SCA market was valued at $373.24million in 2024 and is projected to expand to $706 million by 2033 at a compound annual growth rate (CAGR) of 7.4%. Factors like increasing prevalence, rising healthcare expenditure, and advancements in drug research are driving this growth.

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