Biohaven stock rises following FDA review and Deutsche Bank’s buy rating

Investing.com -- Shares of Biohaven Ltd. (NYSE: BHVN) climbed 7% as the company announced the FDA’s acceptance and Priority Review of its troriluzole New Drug Application (NDA) for the treatment of spinocerebellar ataxia (SCA), alongside a favorable initiation of coverage by Deutsche Bank (ETR:DBKGn).

Deutsche Bank analyst David Hoang initiated coverage on Biohaven with a Buy rating and a price target of $65.00, highlighting the potential of the company’s clinical assets and the leadership of CEO Vlad Coric. "At current share prices, we see meaningful upside if Biohaven succeeds with any of its three mid/late-stage clinical assets," Hoang stated.

The FDA’s decision to grant Priority Review to troriluzole, which would be the first approved treatment for SCA, has been met with optimism. The agency’s review is a response to the significant improvement the drug could offer over existing treatments, with a decision expected within 6 months, potentially leading to commercialization in the US in 2025.

Melissa Beiner, M.D., SCA Clinical Development Lead at Biohaven, expressed the company’s dedication to addressing the unmet needs in SCA, a life-threatening neurodegenerative disease with no available treatment. "The robust clinical data presented in the NDA demonstrate sustained and compelling treatment benefit in SCA patients treated with troriluzole," said Beiner.

The NDA submission was bolstered by positive topline results from a real-world evidence study, showing troriluzole significantly slowed disease progression at the 3-year endpoint. The drug’s safety profile has been established over 8 years of clinical research.

Jeremy Schmahmann, M.D., Professor of Neurology at Harvard Medical (TASE:PMCN) School, emphasized the urgency and potential impact of troriluzole for SCA patients, stating, "The delay in disease decline shown in the real-world evidence study is a watershed in the history of the SCAs."

Biohaven’s progress in SCA treatment has been acknowledged with Fast-Track and Orphan Drug Designations from the FDA, and the European Medicines Agency is currently reviewing a troriluzole Marketing Authorization Application.

The company’s stock movement reflects investor confidence in its strategic direction, underscored by the FDA’s Priority Review and Deutsche Bank’s positive outlook.

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