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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