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Reata's Stock Plunges After FDA Identifies Review Issues With Bardoxolone Methyl US Application

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Reata's Stock Plunges After FDA Identifies Review Issues With Bardoxolone Methyl US Application
  • Reata Pharmaceuticals Inc (NASDAQ: RETAissued an update regarding its Bardoxolone Methyl application for chronic kidney disease (CKD) caused by Alport syndrome.
  • The FDA completed a bio-research monitoring inspection and identified four significant clinical and statistical review issues.
  • The agency did not designate any safety issues as significant issues.
  • Based on its current review, FDA stated that it does not believe a Risk Evaluation and Mitigation Strategies program is needed. The FDA also advised that an Advisory Committee meeting is tentatively scheduled for December 8. The FDA action date for the application is scheduled for February 25, 2022.
  • Reata also said that based on a communication received from the FDA, it withdrew the request for a Type C meeting for its Omaveloxolone in Friedreich's Ataxia.
  • It requested a pre-NDA meeting, which has been accepted and scheduled during the Q3 of 2021.
  • Reata expects to submit an omaveloxolone U.S. application in Q1 of 2022.
  • The Company ended the quarter with cash and equivalents of $755.7 million, sufficient to last through mid-2024.
  • Price Action: RETA shares plunge 18.1% at $100 premarket on the last check Tuesday.
  • Related content: Benzinga's Full FDA Calendar.
 

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