Additional Relevant Details FDA has completed its review of the Biohaven’s investigational drug application (IND) for BHV-4157 filed on May 31, 2016 and informed Biohaven that clinical trials in humans may proceed. The IND for BHV-4157 includes plans for a pivotal trial in the indication of Spinocerebellar Ataxia (SCA), a rare and debilitating neurodegenerative disorder with no currently approved treatment. Biohaven plans to initiate a pivotal Phase III clinical trial in SCA before the end of the year.