Biohaven's stock surges as treatment slows progress of neurological disorder

By Eleanor Laise

Company plans to apply for regulatory approval later this year

Shares of Biohaven Ltd. (BHVN) climbed 13% premarket on Monday after the biotech company said its treatment for a rare neurological disorder slowed the progress of the condition in a clinical trial.

Patients with spinocerebellar ataxia, a genetic disorder that can cause loss of muscle control, balance and coordination, showed a 50% to 70% slowing of disease progression when treated with Biohaven's troriluzole, the company said in a release.

The company said it plans to apply for U.S. regulatory approval of troriluzole for the treatment of spinocerebellar ataxia in the fourth quarter of this year. The application is eligible for priority review, Biohaven said.

There are currently no FDA-approved treatments for spinocerebellar ataxia, which affects about 15,000 people in the U.S. and 24,000 in Europe and the United Kingdom, Biohaven said. Troriluzole is the first treatment to show a delay in disease progression, helping patients achieve additional years of independence, Susan Perlman, director of the ataxia clinic and neurogenetics clinical trials at UCLA's David Geffen School of Medicine, said in a statement.

The FDA last year declined to review Biohaven's application for approval of troriluzole because the application was based on a study that did not meet its primary goal. The company said at the time that the FDA had not given complete consideration to all the available data and that it would keep working with the agency to address its concerns.

The new analysis, Biohaven said Monday, doubled the previously available three-year data, with 63 patients completing three years of troriluzole treatment.

Biohaven was spun off when Pfizer Inc. (PFE) acquired Biohaven Pharmaceutical Holding Company Ltd., the maker of migraine drug Nurtec ODT, in 2022.

Biohaven's stock has dropped 5.6% in the year to date, while the S&P 500 SPX has gained 19.6%.

-Eleanor Laise

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09-23-24 0919ET

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