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Myelofibrosis Combo Advances as Karyopharm Preps August sNDA

Karyopharm Therapeutics is preparing an sNDA submission in August 2026 for accelerated approval of its selinexor-ruxolitinib combination therapy for myelofibrosis, based on positive Phase 3 SENTRY trial data showing significant spleen volume reduction. The FDA has accepted SVR35 as a surrogate endpoint for accelerated approval in this rare blood cancer, which affects thousands of patients in the US and EU. Despite recent analyst target reductions due to a separate trial miss, institutional ownership remains high, signaling confidence in Karyopharm's myelofibrosis program.

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Myelofibrosis Combo Advances as Karyopharm Preps August sNDA | TahmVest News · TahmVest