That bullish stance Karyopharm took on its subgroup cancer study data? The FDA wasn't impressed
Karyopharm ran into plenty of trouble trying to convince analysts that it had all the data it needed to win a new approval for Xpovio (selinexor) for front-line maintenance of endometrial cancer. But it turns out that the FDA is even more skeptical.
The biotech announced after the market bell on Tuesday that the FDA is demanding a new trial of the drug in the p53 wild-type population — the subpopulation where the drug produced the best data — before it will consider a market approval.
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