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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