Eric Dube, Travere Therapeutics CEO

Tra­vere fails to con­vince reg­u­la­tors to con­sid­er ac­cel­er­at­ed ap­proval for a rare kid­ney dis­ease — again

As the old say­ing goes, ‘If at first you don’t suc­ceed, try, try again.’ The ori­gin of this mantra is dis­put­ed but has been wide­ly at­trib­uted to Robert the Bruce, the first king of Scot­land, as he and his army did bat­tle with in­vad­ing Eng­lish forces in the ear­ly 14th cen­tu­ry.

But what hap­pens if you try a sec­ond time and again don’t suc­ceed?

Tra­vere Ther­a­peu­tics will be ask­ing it­self that ques­tion af­ter a sec­ond at­tempt to gun for ac­cel­er­at­ed ap­proval was re­ject­ed by the FDA, the com­pa­ny an­nounced Wednes­day af­ter­noon. The for­mer Mar­tin Shkre­li biotech had at­tempt­ed to push through its lead drug, sparsen­tan, to a speedy OK in a rare kid­ney dis­ease, but reg­u­la­tors pre­fer the more me­thod­i­cal, full ap­proval route.

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