U.S. Food and Drug Administration Accepts Karyopharm’s Supplemental New Drug Application for XPOVIO® (Selinexor) as a Treatment for Patients with Relapsed or Refractory Diffuse Large B-Cel...
Karyopharm Therapeutics Inc. (KPTI)
Last karyopharm therapeutics inc. earnings: 2/13 07:00 am
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Source: GlobeNewswire
NEWTON, Mass., Feb. 19, 2020 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an oncology-focused pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its supplemental New Drug Application (sNDA) seeking accelerated approval for oral XPOVIO® (selinexor) tablets, the Company’s first-in-class, Selective Inhibitor of Nuclear Export (SINE) compound, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (RR DLBCL), not otherwise specified, who have received at least two prior therapies. The FDA also granted Karyopharm’s request for Priority Review and assigned a user fee goal date of June 23, 2020 under the Prescription Drug User-Fee Act (PDUFA). “We look forward to supporting the FDA through the review process for our second NDA for XPOVIO as there remains significant unmet medical need for patients whose DLBCL has relapsed or is refractory to multiple drug therapies,” sai
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KPTI
Earnings
- 2/29/24 - Miss
KPTI
Sec Filings
- 4/23/24 - Form 4
- 4/19/24 - Form ARS
- 4/19/24 - Form DEFA14A
- KPTI's page on the SEC website