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Karyopharm and Menarini Group Enter into Exclusive License Agreement to Commercialize NEXPOVIO® (selinexor) in Europe and Other Key Global Territories
prnasia
December 22, 2021
Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, and the Menarini Group, ("Menarini"), a privately-held...
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Antengene's Partner Karyopharm Therapeutics Announces Updated Data of Eltanexor in Patients with Hypomethylating Agent Refractory MDS
prnasia
June 09, 2021
Antengene's Partner, Karyopharm Therapeutics Inc., announced updated data of eltanexor for the treatment of patients with hypomethylating agent (HMA) refractory myelodysplastic syndrome (MDS) at the 2021 American Society of Clinical Oncology (ASCO) ...
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Antengene announces China’s NMPA approval for IND application for ATG-019 clinical trial
pharmaceutical-business-review
April 06, 2021
Antengene has announced that China’s National Medical Products Administration (NMPA) has given approval to investigational new drug (IND) application for Phase I clinical trials of ATG-019 (monotherapy or combined with niacin ER) in patients with ...
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Antengene Announces its U.S. Partner, Karyopharm Therapeutics Inc., has received FDA Approval of XPOVIO® (Selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior Therapy
prnasia
December 21, 2020
Antengene Corporation Limited today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) submitted by its partner Karyopharm Therapeutics Inc. for oral XPOVIO® (selinexor, ATG-010) ...
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Karyopharm’s Xpovio nabs myeloma nod despite checkered past
fiercepharma
July 09, 2019
Karyopharm finally got its much-needed first commercial approval for a drug that has stirred up safety concerns—and suffered plenty of speed bumps—along the way. Now the company must cope with a limited FDA nod, and with a brand-new marketing chief to boo
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FDA approves Karyopharm’s multiple myeloma drug Xpovio
pharmaceutical-technology
July 05, 2019
The US Food and Drug Administration (FDA) has awarded accelerated approval to Karyopharm Therapeutics’ Xpovio (selinexor) to treat relapsed or refractory multiple myeloma (RRMM) in adults.
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Advisers urge FDA to delay decision on Karyopharm cancer drug
pharmaphorum
February 28, 2019
Advisers to the US drugs regulator have said a decision on whether to approve Karyopharm’s multiple myeloma combination should be delayed until the results of a phase 3 trial, due late this year or in 2020.
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Karyopharm Announces Submission of Marketing Authorization Application to the European Medicines Agency for Selinexor for the Treatment of Patients with Penta-Refractory Multiple Myeloma
firstwordpharma
January 09, 2019
"The MAA submission for selinexor is an important milestone for Karyopharm and the CHMP's granting of accelerated assessment further underscores the urgent need to improve outcomes for patients with highly refractory multiple myeloma," said Sharon Shacham
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Karyopharm slumps, then leaps on selinexor multiple myeloma data
fiercebiotech
May 02, 2018
Karyopharm Therapeutics’ stock took a bit of a roller-coaster ride Monday—it dipped 15% as investors waited for an update on the phase ...
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Bad start to month for Karyopharm gets worse with clinical hold
pharmafile
March 14, 2017
Coming just over a week after Karyopharm Therapeutics had announced that its lead drug had failed in a Phase 2 trial to extend overall survival, it was also hit with a partial clinical trial hold on the same drug.