Richard Paulson, Karyopharm CEO

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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