Why Reata Pharma Shares Are Trading Lower After Q2 Earnings Update?

• Reata Pharmaceuticals Inc (NASDAQ: RETA) completed a mid-cycle communication meeting with the FDA regarding the marketing application review status for omaveloxolone for Friedreich's ataxia.

• The FDA stated that it had not identified any new significant issues, but it continues to have concerns regarding the strength of the efficacy evidence.

• The agency did not identify any significant clinical safety issues.

• The FDA stated that the safety review is ongoing, and they are continuing to evaluate the cardiac safety of omaveloxolone in patients with Friedreich's ataxia, a rare genetic disease that causes difficulty walking.

• They have not identified any other major safety concerns at this stage of their review.

• The regulatory agency has assigned Priority Review for the application and set a PDUFA target action date of November 30.

• Results of the updated Delayed-Start Analysis from the March 2022 data cut-off demonstrated that the between-group difference in Friedreich's ataxia scale was observed at the end of the placebo-controlled MOXIe Part 2 treatment preserved at MOXIe Extension Week 72 in the delayed-start period.

• The threshold for non-inferiority was met at Extension Week 120.

• Reata held a cash balance of $481.5 million.

• Price Action: RETA shares are down 32% at $24.26 on the last check Monday.

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