Biohaven (BHVN) stock plummeted on Wednesday after the U.S. Food and Drug Administration (FDA) sent it a Complete Response Letter (CRL) for the clinical-stage biopharmaceutical company’s VYGLXIA New Drug Application (NDA). This NDA sought approval for VYGLXIA as a treatment for spinocerebellar ataxia (SCA), a group of inherited neurodegenerative disorders that affect the cerebellum and spinal cord, which leads to progressive loss of coordination and movement control.
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The big news here is that the FDA rejected Biohaven’s NDA for VYGLXIA as an SCA treatment. It did so for a variety of factors, including potential bias, design flaws, lack of pre-specification, and unmeasured confounding factors. The company plans to seek a meeting with the FDA to discuss this CRL and what it should do moving forward.
Biohaven Chairman and CEO Vlad Coric said, “We are extremely disappointed on behalf of patients by this action from the Office of Neuroscience at FDA. Beyond substantial evidence of safety and efficacy, patients with rare diseases also deserve an efficient, fair and flexible regulatory process that aligns with the urgency of their high unmet medical needs. Such an approach has been mandated by Congress to empower the FDA with maximum regulatory flexibility for rare disease.”
Biohaven Stock Movement Today
Biohaven stock was down 40% in pre-market trading on Wednesday, following a 6.06% fall yesterday. The stock has also decreased 62.65% year-to-date and 74.04% over the past 12 months.
Today’s news brought with it heavy trading for BHVN stock, as some 2.5 million shares changed hands. For comparison, the company’s three-month daily average trading volume is about 2.24 million units.
Is Biohaven Stock a Buy, Sell, or Hold?
Turning to Wall Street, the analysts’ consensus rating for Biohaven is Strong Buy, based on 13 Buy and a single Hold rating over the past three months. With that comes an average BHVN stock price target of $37.92, representing a potential 171.83% upside for the shares.
