H.C. Wainwright halved its price target for Acasti Pharma (NASDAQ:ACST) to $3 from $6 in light of the continued uncertainty around the company’s TRILOGY 1 and TRILOGY 2 trials. The stock closed at 57 cents on Feb. 14.
Acasti is developing an omega-3-based therapeutic, known as CaPre, for the treatment of hyperglyceridemia. Last month, the pivotal TRILOGY-1 trial missed its primary endpoint because of an unexplained high placebo effect.
Analyst Andrew Fein writes that while Acasti plans to pursue FDA feedback for the TRILOGY 1 audit and post-hoc data review, including audit of five specific sites with greater placebo responses, “we believe there are underlying questions that remain.” Specifically, he cited the “expectations for the statistical analysis plan for TRILOGY 2 for potentially pursuing approval and what are the implications for post-hoc analysis of TRILOGY 1?.”
Mr. Fein said the unblinding of topline TRILOGY 2 data is anticipated in the third quarter of 2020. “We note that the company anticipates FDA guidance to inform how best to conduct the continued data analysis,” he added.