Karyopharm's Myeloma Candidate Gets Fast Track Designation
Zacks Investment Research | Apr 10, 2018 11:56PM ET
Karyopharm Therapeutics Inc.'s (NASDAQ:KPTI) shares increased more than 6% on Apr 10 after the company announced that its oral selective inhibitor of nuclear export (SINE) compound, selinexor (KPT-330), has been granted a fast track designation by the FDA.
The company is looking to get the candidate approved for treatment of patients with penta-refractory multiple myeloma, having received at least three prior lines of therapy.
The FDA grants a fast track designation to expedite a candidate’s development as well as its faster review to treat serious and unmet medical conditions. With this designation, a candidate is expected to be granted a priority review once it files a new drug application.
This news is a huge positive for the company as it comes ahead of the data from a phase IIb STORM study on selinexor, expected by the end of this April. The study is evaluating selinexor with low-dose dexamethasone on 122 penta-refractory multiple myeloma patients.
Positive data from the trial will allow the company to submit a regulatory application to the FDA during the second half of 2018. It will also pave the way for selinexor’s accelerated approval in the United States for the given indication.
Karyopharm’s shares have rallied 29.6% year to date against the Zacks Investment Research
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