Harmony data for Wakix in DM1 ‘raises several concerns,’ says Goldman Sachs

After Harmony Biosciences announced topline results from its Phase 2 signal detection study evaluating the safety and efficacy of pitolisant in adult patients with myotonic dystrophy type 1, or DM1, Goldman Sachs argued that the data “raises several concerns” and contended that the likelihood of treatment with a branded product such as Wakix for this disease “remains unclear.” The firm, which expects a pivotal trial will be required to substantiate results and support approval, reiterates a Sell rating on Harmony shares.