FDA Partial Hold on Epilepsy Drug Sends Biohaven Shares Down 14%
BHVN sits 70% above its 52-week low of $7.48.
Summary
Biohaven shares fell 14% to $12.87 after the FDA placed a partial clinical hold on the RISE-2 study of its epilepsy drug opakalim. The hold, disclosed in an 8-K earlier today, pauses new patient enrollment due to insufficient information about a metabolite found in rodent testing. Currently enrolled patients continue treatment. The company must complete RISE-2 and a separate late-stage study, RISE-3, to seek approval; RISE-3 data is expected later this year. This setback adds to a string of pipeline failures and a 60% R&D budget cut in November 2025, intensifying pressure on the cash-strapped biotech. William Blair analyst Myles Minter notes the delay widens Xenon Pharmaceuticals' first-mover advantage in epilepsy.
At the time of this announcement, BHVN was trading at $12.75 on NYSE in the Life Sciences sector, with a market capitalization of approximately $1.9B. The 52-week trading range was $7.48 to $18.57. This news item was assessed with negative market sentiment and an importance score of 8 out of 10. Source: Dow Jones Newswires.