FDA orders Karyopharm to halt enrollment for all selinexor trials, citing incomplete safety warning
Late Friday night Karyopharm Therapeutics $KPT alerted investors that the FDA has slapped a partial hold on all studies involving its lead cancer drug selinexor, halting enrollment for work on a drug that was recently tapped for a 2018 filing with the FDA.
Regulators ordered the partial hold after citing, in writing, incomplete information in a brochure on the drug which included an incomplete list of the adverse events associated with the drug. The statement does not say when the agency first informed the company of the partial hold, but Karyopharm says that as of Friday the company has supplied the information requested to get the hold lifted.
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.