BHVN Stock Eyes Biggest Single-Day Gain In 4 Years After FDA Approval For Vyglxia

• The FDA issued a Complete Response Letter last November, declining to approve the drug.
• The FDA set a target deadline for the first quarter of 2027.
• Biohaven held about $270.5 million in cash, marketable securities and restricted cash as of June 30.

Shares of Biohaven (BHVN) ripped in pre-market trading on Thursday, after the biotech firm announced that the U.S. Food and Drug Administration (FDA) accepted its resubmitted application for its experimental neurological disease drug.

BHVN shares were up more than 36% at the time of writing, tracking their biggest single-day gain in more than four years.

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Biohaven Gets A Second Chance

This comes as a relief for Biohaven investors after the FDA issued a Complete Response Letter (CRL) last November, declining to approve the drug over concerns about the clinical evidence supporting its effectiveness. Vyglxia is an experimental oral treatment for spinocerebellar ataxia (SCA), a rare inherited neurological disease that affects balance, coordination, walking and speech.

Although Biohaven reported that the drug slowed disease progression by 50% to 70% over a three-year period, the FDA raised concerns about flaws in the study design. Following the rejection, Biohaven announced plans to cut annual direct research and development spending by about 60%.

The agency said the updated application, which includes additional positive analyses, adequately addresses its November rejection letter. The FDA has set a target deadline for the first quarter (Q1) of 2027, based on input from external stakeholders.

Biohaven’s Pipeline In Focus

Beyond Vyglxia, Biohaven is developing BHV-1300 for Graves’ disease, an autoimmune thyroid disorder, and BHV-1400 for a kidney disease called IgA nephropathy. Its pipeline also includes Opakalim for epilepsy, Taldefgrobep alfa for obesity and BHV-1530 for cancer.

Biohaven remains a clinical-stage company without commercial drug sales. It held about $270.5 million in cash, marketable securities and restricted cash as of June 30.

Retail Chatter Is Mixed

Retail sentiment surrounding BHVN on Stocktwits flipped to ‘bullish’ from ‘neutral’ over the past 24 hours, amid ‘extremely high’ message volumes.

One user said the drug will not be a money maker even if it gets approval.

Another user called it “incredible news”

The stock has gained around 9% so far this year.

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