Biotech pulls plans to file ac­cel­er­at­ed ap­proval af­ter FDA 'change in di­rec­tion' — shares plum­met

When the FDA lift­ed a clin­i­cal hold on Ap­plied Ther­a­peu­tics’ lead pro­gram in galac­tosemia last Feb­ru­ary, the New York biotech sig­naled that they were then on a smooth road to­ward an ac­cel­er­at­ed ap­proval, with plans to file an NDA in the third quar­ter of 2021.

Reg­u­la­tors, though, ap­par­ent­ly changed their mind.

Ap­plied has de­cid­ed to hold on sub­mit­ting an NDA for AT-007 as a treat­ment for galac­tosemia, the com­pa­ny dis­closed, fol­low­ing dis­cus­sions with the FDA in which the agency in­di­cat­ed that “clin­i­cal out­comes da­ta will like­ly be re­quired for ap­proval.”

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