Another FDA setback for Reata's omaveloxolone program in FA

Shares of US biotech Reata Pharmaceuticals (Nasdaq: RETA) fell 7.6% to $151.89 yesterday, after it announced that the US Food and Drug Administration has completed its internal review of the Baseline-Controlled Study results of omaveloxolone for the treatment of patients with Friedreich’s ataxia (FA) and concluded that the results do not strengthen the results of Part 2 of the MOXIe study.

The FDA proposed some additional exploratory analyses using patients randomized to placebo during the MOXIe Part 2 study, but stated that the potential for these analyses to strengthen the study results was questionable due to the small number of patients available for analysis. The FDA stated that it remains interested in reviewing the results of the additional exploratory analyses as those may inform the future development program.

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