Newton, MA (Press Release) – Karyo­pharm Thera­peutics Inc. (Nasdaq:KPTI), an inno­va­tion-driven pharma­ceu­tical com­pany, to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) has ac­cepted for filing its supple­mental New Drug Appli­ca­tion (sNDA) seek­ing ap­prov­al for XPOVIO^® (seli­nexor), its first-in-class, oral Sel­ective Inhibitor of Nuclear Export (SINE) com­pound, as a new treat­ment for patients with mul­ti­ple myeloma after at least one prior line of ther­apy. Karyo­pharm ex­pects a de­ci­sion from the FDA re­gard­ing this sNDA before the end of the first quarter of 2021.

“This sNDA ac­ceptance brings us one step closer to …

Newton, MA (Press Release) – Karyo­pharm Thera­peutics Inc. (Nasdaq:KPTI), an inno­va­tion-driven pharma­ceu­tical com­pany, to­day an­nounced it has sub­mitted a supple­mental New Drug Appli­ca­tion (sNDA) to the U.S. Food and Drug Admin­istra­tion (FDA) seek­ing ap­prov­al for XPOVIO® (seli­nexor), its first-in-class, oral Sel­ective Inhibitor of Nuclear Export (SINE) com­pound, as a new treat­ment for pa­tients with pre­vi­ously treated mul­ti­ple myeloma.

“Earlier this year, we reported pos­i­tive top-line results from the pivotal Phase 3 BOSTON study eval­u­ating the com­bi­na­tion of XPOVIO (seli­nexor), once-weekly Velcade® (bor­tez­o­mib) and low-dose dexa­meth­a­sone (SVd) as a sec­ond line treat­ment for patients …

Shanghai, China (Press Release) – Anten­gene Corpo­ra­tion (Antengene) to­day an­nounced a broadened part­ner­ship and territory ex­pan­sion agree­ment with Karyo­pharm Thera­peutics Inc. (NASDAQ: KPTI) (Karyopharm) for de­vel­op­ment and com­mer­cial­iza­tion of four oral novel drugs and drug can­di­dates to sup­port its mission of treating patients beyond borders. This agree­ment broadens Anten­gene's rights in the Asia Pacific region for XPOVIO® (seli­nexor, aka ATG-010), the first-in-class sel­ective in­hib­i­tor of nuclear export (SINE); eltanexor (ATG-016), a sec­ond-generation SINE com­pound; verdinexor (ATG-527), a lead com­pound in de­vel­op­ment for anti-viral and other non-oncology in­di­ca­tions; and KPT-9274 (ATG-019), a dual in­hib­i­tor …

Newton, MA (Press Release) – Karyo­pharm Thera­peutics Inc. (Nasdaq:KPTI) to­day an­nounced dosing of the first patient in a ran­dom­ized Phase 2 clin­i­cal study eval­u­ating low dose oral selinexor in hos­pi­talized patients with severe COVID-19. This global study is ex­pected to en­roll approx­i­mately 230 patients at clin­i­cal sites in the U.S., Europe, and Israel. Selinexor is an oral selective in­hib­i­tor of nuclear export (SINE) com­pound which blocks the cellular pro­tein XPO1 which is in­volve­d in both the rep­li­ca­tion of SARS-CoV-2, the virus that causes COVID-19, and in the in­flam­ma­tory re­sponse to the virus.

The …

• Company to Initiate a Global Randomized Clinical Trial to Treat Patients with COVID-19
• XPO1 Inhibitors have Previously Demonstrated Pre­clin­i­cal Activity Against Numerous Respiratory Viruses (Including SARS-CoV) and Asso­ci­ated Inflammation
• BOSTON sNDA Submission on Target for Q2 2020
• Management to Host Conference Call Today at 8:30 AM ET

Newton, MA (Press Release) – Karyo­pharm Thera­peutics Inc. (Nasdaq:KPTI) to­day announced plans to ini­ti­ate a global ran­dom­ized clin­i­cal trial for low dose oral selinexor in hos­pi­talized patients with severe COVID-19. Selinexor, mar­keted as XPOVIO®, is cur­rent approved at higher doses by the Food and Drug Admin­istra­tion (FDA) as a treat­ment for patients with re­lapsed or re­frac­tory multiple myeloma. Selinexor is an oral, selective in­hib­i­tor of nuclear export (SINE) com­pound which blocks the cellular pro­tein XPO1. In addi­tion to …

• Combination of Once-Weekly XPOVIO® (seli­nexor), Once-Weekly Velcade® (bor­tez­o­mib) plus Dexa­meth­a­sone (SVd) Results in Statistically Significant Reduction in the Risk of Disease Pro­gression or Death Compared to Standard Twice-Weekly Velcade® plus Dexa­metha­sone (Vd) Regimen
• 47% Increase in Median PFS on SVd versus Vd
• Regulatory Submission Planned in 2Q 2020; Data to be Submitted for Presentation at Upcoming Medical Meetings
• Management to Host Conference Call Today at 8:30 AM ET

Newton, MA (Press Release) – Karyo­pharm Thera­peutics Inc. (Nasdaq:KPTI), an on­col­ogy-focused pharma­ceu­tical com­pany, today announced pos­i­tive top-line results from the ran­dom­ized Phase 3 BOSTON study eval­u­ating once-weekly XPOVIO® (seli­nexor) in com­bi­na­tion with once-weekly Velcade® (bor­tez­o­mib) and low-dose dexa­meth­a­sone (SVd) com­pared to standard twice-weekly Velcade plus low-dose dexa­meth­a­sone (Vd) in patients with multiple myeloma who have re­ceived one to three prior lines of ther­apy. The BOSTON study met its pri­mary end­point of a statistically sig­nif­i­cant in­crease in …

Newton, MA and Petah Tikva, Israel (Press Release) – Karyo­pharm Thera­peutics Inc. (Nasdaq:KPTI), an on­col­ogy-focused pharma­ceu­tical com­pany, and Promedico, a member of the Neopharm Group, today announced their entry into an ex­clu­sive distribution agree­ment for the com­mer­cial­iza­tion of XPOVIO® (seli­nexor), Karyo­pharm’s lead SINE com­pound, in Israel and the Palestinian Authority.

Under the terms of the agree­ment, Karyo­pharm will re­ceive cer­tain prespecified pay­ments and is eli­gible to re­ceive addi­tional pay­ments if prespecified regu­la­tory and commercial mile­stones are achieved by Promedico, a fully-owned Neopharm LTD com­pany. Karyo­pharm is also eli­gible to re­ceive double-digit royalties on …