FDA places partial clinical hold on Biohaven's epilepsy drug days after $795 million SK Biopharmaceuticals deal
The US Food and Drug Administration (FDA) has issued a partial clinical hold on Biohaven's (NYSE: BHVN) investigational epilepsy drug opakalim (BHV-7000), pausing new patient enrollment in one of two pivotal Phase III trials pending further data on a metabolite identified in rodent testing, according to an 8-K filing.
Issued September 4, the hold affects trial BHV7000-302 (known as RISE-2), where enrollment is paused until Biohaven provides additional nonclinical data characterizing the metabolite's significance to humans.
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