We are investigating Karyopharm Therapeutics Inc. (KPTI) (“Karyopharm” or the “Company”) for potential violations of the federal securities laws.
On February 22, 2019, in advance of a U.S. Food and Drug Administration (“FDA”) advisory committee meeting to review Karyopharm’s New Drug Application (“NDA”) for selinexor and assess the drug’s risks and benefits, the FDA released a briefing document expressing serious concerns about the safety and efficacy of selinexor (the “FDA Report”). Significantly, the FDA Report revealed that, contrary to Karyopharm’s assurances, the Company’s previously cancelled Phase 2 SOPRA trial had resulted in “worse overall survival” for acute myeloid leukemia (“AML”) patients treated with selinexor, which “highlight[ed] the toxicity of this drug.” The FDA also determined that the toxicity observed with selinexor in AML patients in the SOPRA study was “similar” to that observed in multiple myeloma patients in the Phase 2b STORM study. The FDA unambiguously concluded that “[t]reatment with selinexor is associated with significant toxicity” and has “limited efficacy.”