Tra­vere takes a hit as FDA staffers shoo off their ac­cel­er­at­ed drug pitch

Three months af­ter the ex­ecs at Tra­vere Ther­a­peu­tics $TVTX picked up in­ter­im da­ta for its treat­ment for a rare kid­ney dis­ease and made a bee­line for the FDA in search of an ac­cel­er­at­ed ap­proval, they’re be­ing turned around and point­ed back to the clin­ic.

Ac­cord­ing to the biotech — more fa­mous­ly known for be­ing found­ed as Retrophin by ex-CEO Mar­tin Shkre­li, now do­ing prison time for fraud — reg­u­la­tors at the FDA told them that “the avail­able da­ta from the in­ter­im as­sess­ment of the DU­PLEX Study (of sparsen­tan) would not be ad­e­quate to sup­port an ac­cel­er­at­ed ap­proval at this time.”

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