Biohaven jumps as FDA takes second look at brain disorder drug
Today 12:49
BUZZ-Biohaven jumps as FDA takes second look at brain disorder drug ** Shares of drugmaker Biohaven BHVN.N rise 43.7% to $16.88 premarket
** US FDA accepts Biohaven's resubmitted new drug application for Vyglxia for review
** Resubmission includes new positive supportive analyses for treating spinocerebellar ataxia, a rare neurodegenerative disorder that affects movement and balance
** Last year, the health regulator declined to approve the treatment, citing concerns over study design, potential bias, and data limitations
** The health agency plans to hold an advisory committee meeting to obtain input from external stakeholders
** FDA assigns a target review decision date in Q1 2027
** As of last close, stock up ~4% YTD
(Reporting by Kamal Choudhury in Bengaluru)
Recent news on Biohaven
See all newsU.S. STOCKS ON THE MOVE-Quest Diagnostics, Tractor Supply, Dutch Bros
Brief: Biohaven - FDA Accepts Biohaven NDA Resubmission For Vyglxia (Troriluzole) In SCA
Biohaven jumps as FDA takes second look at brain disorder drug
Brief: Biohaven Enters Strategic Licensing Agreement With Ono Pharma
Ono Pharma Announces An Exclusive License Agreement With Biohaven To Develop And Commercialize Igg Degraders In Japan, South Korea, Taiwan, And Asean