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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER