Articles tagged with: Selinexor

Press Releases»

[ by | Aug 6, 2018 4:05 pm | Comments Off ]

Company to Host Conference Call to Discuss Second Quarter 2018 Financial Results and Recent Business Developments on Tuesday, August 7, 2018 at 8:30 a.m. ET

Karyopharm Completes Rolling Submission Of New Drug Application To U.S. Food And Drug Administration For Selinexor As A Treatment For Patients With Penta-Refractory Multiple Myeloma Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage pharma­ceu­tical com­pany, today announced the completion of the rolling sub­mission of a New Drug Application (NDA) to the U.S. Food and Drug Admin­istra­tion (FDA) seeking accelerated approval for selinexor, its novel, oral SINE com­­pound, as a new treat­ment for patients with penta-refractory multiple myeloma. Patients with penta-refractory myeloma have pre­vi­ously received the two pro­te­a­some inhibitors (PIs), Velcade® (bor­tez­o­mib) and Kyprolis® (car­filz­o­mib), the two immuno­modu­la­tory drugs (IMiDs), Revlimid® (lena­lido­mide) and Pomalyst® (poma­lido­mide), and the anti-CD38 mono­clonal anti­body Darzalex® (dara­tu­mu­mab) as …

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Press Releases»

[ by | Jul 18, 2018 7:00 am | Comments Off ]

Company Plans to Complete Submission During the Second Half of 2018

Karyopharm Initiates Rolling Submission Of New Drug Application To U.S. Food And Drug Administration For Selinexor As A Treatment For Patients With Penta-Refractory Multiple Myeloma Newtown, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage pharma­ceu­tical com­pany, today announced that the Company has ini­ti­ated a rolling sub­mission of a New Drug Application (NDA) to the U.S. Food and Drug Admin­istra­tion (FDA) seeking accelerated approval for selinexor, its novel, oral SINE com­­pound, as a new treat­ment for patients with penta-refractory multiple myeloma. Patients with penta-refractory myeloma have pre­vi­ously received the two pro­te­a­some inhibitors (PIs), Velcade® (bor­tez­o­mib) and Kyprolis® (car­filz­o­mib), the two immuno­modu­la­tory drugs (IMiDs), Revlimid® (lena­lido­mide) and Pomalyst® (poma­lido­mide), and the anti-CD38 mono­clonal anti­body Darzalex® (dara­tu­mu­mab), …

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Press Releases»

[ by | May 24, 2018 7:00 am | Comments Off ]
  • Antengene Rights Include All Human Oncology Indications for Selinexor, Eltanexor and KPT-9274, and Non-Oncology Human Indications for Verdinexor
  • Karyopharm to Receive $12 Million (USD) Upfront; Total Deal Valued at up to $162 Million with Karyo­pharm Eligible to Receive up to $150 Million (USD) in Future Milestones, Plus Royalties

Karyopharm And Antengene Sign Exclusive License Agreement To Develop And Commercialize Selinexor, Eltanexor, Verdinexor And KPT-9274 In China And Other Regions In Asia Newton, MA and Shanghai, China (Press Release) – Karyo­pharm Thera­peutics Inc. (Nasdaq:KPTI) (Karyopharm) and Antengene Corpo­ra­tion (Antengene), to­day an­nounced their entry into an ex­clu­sive license agree­ment for the de­vel­op­ment and com­mer­cial­iza­tion of four of Karyo­pharm’s novel, oral drug can­di­dates, in­clud­ing selinexor, Karyo­pharm’s lead SINE com­pound, eltanexor, Karyo­pharm’s sec­ond-generation SINE com­pound, verdinexor, Karyo­pharm’s lead com­pound in de­vel­op­ment for viral and other non-oncology in­di­ca­tions, and KPT-9274, Karyo­pharm’s dual in­hib­i­tor of PAK4 and NAMPT. The agree­ment in­cludes the de­vel­op­ment and com­mer­cial­iza­tion of selinexor and …

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[ by | May 15, 2018 12:44 pm | Comments Off ]
Neue Studienergebnisse verstärken die Erwartungen an Selinexor beim Myelom; Antrag auf FDA-Zulassung soll später in diesem Jahr gestellt werden

Neue klinische Studienergebnisse für Selinexor, eine mögliche neue Myelom­behandlung, wurden letzte Woche von Karyopharm Therapeutics, dem US-Unternehmen, das das Medikament entwickelt, veröffentlicht.

Die neuen Ergebnisse sind "top line"-Ergebnisse und daher im Umfang be­grenzt. Sie stimmen jedoch mit den positiven Ergebnissen überein, die zuvor in Studien mit Selinexor in Kombination mit Dexamethason bei stark vorbehandel­ten Patienten mit multiplem Myelom erzielt wurden. Zusammengenommen deuten die Ergebnisse darauf hin, dass die auf Selinexor basierende Medika­mentenkombination eine bemerkenswerte Anti-Myelom-Aktivität aufweist.

Karyopharm (NASDAQ:KPTI) begleitete letzte Woche die Veröffentlichung der neuen Selinexor-Daten mit einem Update seiner Zulassungspläne für …

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News»

[ by | May 9, 2018 11:29 am | 4 Comments ]
New Trial Results Reinforce Expectations For Selinexor In Myeloma; Application For FDA Approval To Be Filed Later This Year

New clin­i­cal trial results for selinexor, a poten­tial new myeloma treat­ment, were released last week by Karyopharm Therapeutics, the U.S. com­pany devel­op­ing the drug.

The new results are “top line” findings, so they are very limited in scope. They are con­sis­tent, how­ever, with the favorable results pre­vi­ously seen in trials of selinexor com­bined with dexa­meth­a­sone in heavily pre­treated multiple myeloma patients. Taken together, the results suggest the selinexor-based two-drug com­bi­na­tion has noteworthy anti-myeloma activity.

Karyopharm (NASDAQ:KPTI) accompanied last week’s release of the new selinexor data with an update on its regu­la­tory plans …

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Press Releases»

[ by | Apr 30, 2018 4:05 pm | Comments Off ]
  • Oral Selinexor Achieves 25.4% Overall Response Rate and Median Duration of Response of 4.4 Months in Patients with Penta-Refractory Myeloma
  • Company Plans to Submit a New Drug Application to the FDA in the Second Half of 2018
  • Selinexor Continues to Demonstrate a Predictable and Manageable Tolerability Profile
  • Management to Host Conference Call Tomorrow, May 1, 2018 at 8:00 a.m. ET

Karyopharm Announces Positive Top-Line Data From Phase 2b STORM Study Evaluating Selinexor In Patients With Penta-Refractory Multiple Myeloma Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage pharma­ceutical com­pany, today reported pos­i­tive top-line results from the Phase 2b STORM study eval­u­ating the Company’s lead, oral Selective Inhibitor of Nuclear Export (SINE) com­­pound selinexor in heavily pre­treated patients with refractory multiple myeloma. Regarding the STORM study’s pri­mary objective, oral selinexor achieved a 25.4% over­all response rate (ORR), which in­cluded two com­plete responses (CRs) and 29 partial (PRs) or very good …

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Press Releases»

[ by | Apr 10, 2018 7:00 am | Comments Off ]
Karyopharm’s Selinexor Receives Fast Track Designation From FDA For The Treatment Of Patients With Penta-Refractory Multiple Myeloma

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage pharma­ceu­tical com­pany, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has granted Fast Track desig­na­tion to the Company’s lead, oral Selective Inhibitor of Nuclear Export (SINE) com­­pound selinexor for the treat­ment of patients with multiple myeloma who have received at least three prior lines of ther­apy. The FDA’s state­ment, con­sis­tent with the design of Karyopharm’s Phase 2b STORM study, noted that the three prior lines of ther­apy in­clude regi­mens com­prised of an alkylating agent, a gluco­corticoid, Velcade® (bor­tezo­mib), Kyprolis® (car­filz­o­mib), …

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