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Karyopharm On The Move…

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Shares of Karyopharm Therapeutics Inc. (KPTI) are up more than 127% from their 52-week low of $3.92 recorded on March 1, 2019.

Karyopharm is a pharmaceutical company developing novel drugs to help treat patients with certain blood cancers or solid tumor malignancies. The Company won FDA approval for its first drug XPOVIO as recently as July 3, 2019.

XPOVIO in combination with dexamethasone has been granted accelerated approval by the FDA for the treatment of adult patients with relapsed or refractory multiple myeloma whose disease is refractory to proteasome Inhibitors, immunomodulatory agents, and an anti-CD38 monoclonal antibody.

In February of this year, an FDA panel voted against the accelerated approval of XPOVIO and recommended that the decision be delayed until results are available from the pivotal phase III BOSTON trial. However, the FDA didn't see any reason to pause the decision and has gone ahead granting accelerated approval.

Continued approval for XPOVIO depends upon the results of BOSTON trial, which will serve as the confirmatory trial. The BOSTON study, which is evaluating XPOVIO in combination with Velcade and low-dose dexamethasone, is underway, with top-line data expected by the end of 2019 or 2020.

XPOVIO, with a wholesale acquisition cost of $22 thousand per month, is expected to become commercially available in the U.S. on or before July 10, 2019.

The drug is also under review by the European Medicines Agency, with a decision expected by the end of this year.

XPOVIO is also being explored in the indications of Diffuse Large B-Cell Lymphoma, Endometrial Cancer and Liposarcoma.

Karyopharm expects to seek accelerated approval and conditional approval for XPOVIO as a treatment for patients with relapsed or refractory Diffuse Large B-Cell Lymphoma in the U.S., and Europe, respectively, in the first half of 2020.

XPOVIO as a maintenance therapy in patients with advanced or recurrent endometrial cancer following one prior platinum-based treatment is under a phase II/III study, dubbed SIENDO. Enrollment in this study is expected to be completed in 2020.

A phase II/III study of XPOVIO in Liposarcoma, dubbed SEAL, is underway, with top-line data from the phase III portion of the study anticipated in 2020.

Also in the pipeline are Eltanexor in a phase I/II study in metastatic castrate-resistant prostate cancer, KPT-9274 in phase I study for the treatment of patients with advanced solid malignancies or non-Hodgkin's lymphoma, and Verdinexor in preclinical studies in a variety of viral indications as well as in autoimmune / inflammatory diseases.

In the first quarter ended March 31, 2019, Karyopharm's net loss widened to $66.2 million or $1.09 per share from $38.5 million or $0.78 per share in the quarter ended March 31, 2018. License and other revenue for the quarter ended March 31, 2019 was $0.2 million compared to $10.0 million for the quarter ended March 31, 2018.

The Company ended March 31, 2019, with cash of $265.1 million, which is expected to be sufficient to fund its operations into the second half of 2020.

KPTI has traded in a range of $3.92 to $21.71 in the last 1 year. The stock closed Wednesday's (July 3, 2019) trading at $8.90, up 36.03%.

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