Why Biohaven's 36% Surge Might Just Be The Beginning

Biohaven (BHVN) +31% after FDA accepted resubmitted drug application for spinocerebellar ataxia. Korro Bio (KRRO) +25% on positive preclinical results for AATD treatment. Actinium (ATNM) +18% with initial Phase 1 data for prostate cancer radiotherapy. Vicore (VCRE) +16% after passing IPF trial futility analysis.

Biohaven's Vyglxia, a drug for spinocerebellar ataxia, will undergo a fresh FDA review after a previous rejection. The FDA will convene an expert panel and issue a decision in Q1 2024. Biohaven claims to have submitted new supportive analyses. The announcement caused a 25% rise in shares and optimistic analyst notes, with some predicting over $1 billion in annual sales if approved.

Biohaven Ltd. shares rose 29.62% to $15.23 after the FDA accepted its resubmitted application for Vyglxia, a treatment for spinocerebellar ataxia. The FDA set a decision deadline for Q1 2027. Biohaven had previously faced regulatory setbacks, including a 28% stock decline over the past year. The company has no revenue and a trailing loss of $4.65 per share.

Baird raised Biohaven Pharma's (BHVN) price target to $48 from $42, citing NDA acceptance for Vyglxia. The stock is up 2.8% over the past week. Biohaven also secured an $80M licensing deal with Ono Pharmaceuticals. The company faces FDA clinical holds on BHV-7000 and opakilim programs, but current patient dosing continues.

Biohaven (BHVN) shares surged 36% in pre-market trading after the FDA accepted its resubmitted application for Vyglxia, a drug for spinocerebellar ataxia. The FDA had previously rejected the application in November 2023. Biohaven is a clinical-stage company with no commercial drug sales and $270.5M in cash as of June 30, 2024. The stock has gained 9% year-to-date.

Biohaven's stock rose 36% premarket after the FDA accepted its resubmitted NDA for Vyglxia to treat spinocerebellar ataxia, with a Q1 2027 decision date.