News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months af­ter Rea­ta Phar­ma­ceu­ti­cals sug­gest­ed its Friedre­ich’s atax­ia pro­gram omavelox­olone could be de­layed, the com­pa­ny re­vealed that is in­deed go­ing to be the case.

Rea­ta $RE­TA shares took a nose­dive Wednes­day af­ter the biotech re­vealed that the FDA said sup­ple­men­tal da­ta for its piv­otal tri­al did not strength­en the case for ap­proval. As a re­sult, the drug is like­ly to need an­oth­er study be­fore the FDA takes up the case.

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