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Karyopharm Therapeutics Inc (KPTI) Q1 2021 Earnings Call Transcript


Karyopharm Therapeutics Inc (KPTI) Q1 2021 Earnings Call Transcript
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Karyopharm Therapeutics Inc (NASDAQ: KPTI)
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Operator
Good morning. My name is Jason, and I ll be your conference operator today. At this time, I would like to welcome everyone to the Karyopharm Therapeutics First Quarter 2021 Financial Results Conference Call. There will be a question-and-answer session to follow. Please be advised that this call is being recorded at the Company s request.
I would now like to turn the call over to Mr. Ian Karp, Karyopharm s Senior Vice President, Investor and Public Relations.SPONSORED: ....

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Karyopharm Announces European Medicines Agency's Validation of its Type II Variation Marketing Authorization Application for NEXPOVIO®


Published: Apr 26, 2021
 
NEWTON, Mass., April 26, 2021 /PRNewswire/ Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the European Medicines Agency (EMA) has validated the Company s Type II Variation Marketing Authorization Application (MAA), which seeks to expand the currently authorized indication for NEXPOVIO® in the European Union to include, in combination with Velcade® (bortezomib) and low-dose dexamethasone, the treatment of adult patients with multiple myeloma who have received at least one prior therapy. Validation of the application confirms the submission is complete to begin the EMA s review process. The MAA is supported by the positive results from the pivotal Phase 3 BOSTON study, which evaluated once-weekly selinexor in combination with once-weekly Velcade® and low-dose dexamethasone (SVd) compared to standard twice-weekly Velcade® plus low-dose dexam ....

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Karyopharm Announces XPOVIO® (selinexor) Receives Regulatory Approval in Israel for the Treatment of Patients with Multiple Myeloma and Diffuse Large B-Cell Lymphoma


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NEWTON, Mass., Feb. 4, 2021 /PRNewswire/  Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that its partner Promedico Ltd., a member of the Neopharm Group, has received a principal approval letter from the Israeli Ministry of Health, Israel s regulatory agency responsible for the approval of new medicines, granting the approval of XPOVIO® (selinexor) for the treatment of patients with either multiple myeloma or diffuse large B-cell lymphoma (DLBCL). The approved indications for XPOVIO are a) in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and b) for the treatment of adult patients with relapse ....

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Karyopharm Receives Positive CHMP Opinion for NEXPOVIO® (selinexor) for the Treatment of Patients with Refractory Multiple Myeloma


Karyopharm Receives Positive CHMP Opinion for NEXPOVIO® (selinexor) for the Treatment of Patients with Refractory Multiple Myeloma
European Commission Decision Anticipated by April 2021
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NEWTON, Mass., Jan. 29, 2021 /PRNewswire/  Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced the European Medicines Agency s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the conditional approval for NEXPOVIO® (selinexor) in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. ....

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