News briefing: After lengthy odyssey, Reata is finally ready for its closeup; MIT's Hockfield takes board seat at Repertoire
Close to 10 years after its once-promising program for bardoxolone in chronic kidney disease imploded on safety fears, Reata is now prepping for its first encounter with an adcomm and FDA marketing decision.
The Dallas biotech reported that the FDA is giving their drug a standard review for chronic kidney disease caused by Alport syndrome. That query turns aside their request for a priority review and sets the PDUFA date at February 25 of next year. The agency also made clear that they will bring together an outside panel of experts to offer their advice on the drug’s fate — which still likely rests considerably on regulators’ tolerance for risk.
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