Reata Pharma hit by setback in FDA review of ataxia treatment

 

• Reata Pharmaceuticals (NASDAQ:RETA) -8.8% after-hours following news that the Food and Drug Administration's review of its proposed omaveloxolone treatment for Friedreich's ataxia, a rare neuromuscular disorder, concluded that the findings do not strengthen the results of Part 2 of the MOXIe study.
• Reata says it is considering next steps for the FA development program including whether to run a second pivotal study in patients with the disorder.
• Reata shares fell by a third in early August when the FDA said it was not convinced that MOXIe study results of omaveloxolone would support a single study approval without additional evidence that lends persuasiveness to the results.

https://seekingalpha.com/news/3639277-reata-pharma-hit-setback-in-fda-review-of-fa-treatment