FDA sends Reata back to the drawing board

Evaluate Vantage, Madeleine Armstrong, November 25, 2020

The need for another pivotal trial of omaveloxolone in Friedreich's ataxia looks increasingly likely. This result for omaveloxolone was not entirely unexpected; Reata said during its second-quarter results that the FDA had asked for a second pivotal trial to support the Moxie study. Part two of Moxie was declared a success, but only after Reata switched endpoints to increase its chances after the first part failed (Reata looks to outsmart Abbvie again, October 15, 2019).

FDA sends Reata back to the drawing board