Biohaven (BHVN) securing approval for troriluzole could transform the company, potentially unlocking a $1.24 billion opportunity, RBC Capital Markets said Thursday.
The US Food and Drug Administration has accepted the company's resubmitted new drug application for troriluzole in spinocerebellar ataxia, a group of rare, genetic neurological disorders, with a Q1 2027 target action date and an advisory committee meeting, the brokerage noted.
Troriluzole "has a real shot to be approved" and the advisory committee is likely to be a key determining factor in the approval, RBC said. However, risks to the approval remain given the product candidate's imperfect data package and uncertainties with the committee vote, the investment firm added.
The estimated $1.24 billion out year opportunity assumes a 2027 launch, RBC said, adding the drug has the potential to capture about 10% of the patient population the same year and then grow to 30% by 2029.
RBC has a sector perform rating on Biohaven, with a price target of $22, up from $19 previously.
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