Vertex's rapid-fire PhIII program hits a roadblock at the FDA. Will regulators force rival Galapagos to slow down too?
Vertex’s R&D team doesn’t make many mistakes. So during yesterday’s Q1 call, a group of analysts were quick to pick up on a rare stumble that just might make it more vulnerable to a rival like Galapagos.
While noting plans for launching a new Phase III effort with a combination drug using VX-445 with Symdeko, following up as planned, investigators $VRTX also conceded that the FDA sees its deuterated version of Kalydeco — VX-561 — as a novel agent that needs some additional dose-ranging trial work before regulators will allow a move into Phase III.
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