Karyopharm Therapeutics Inc. (KPTI - Free Report) announced that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for its oral selective inhibitor of nuclear export (SINE) compound selinexor. The company is seeking a conditional approval for selinexor regarding the treatment of patients with penta-refractory multiple myeloma (MM), having received at least three prior lines of therapy.
The MAA was based on positive results from the pivotal phase IIb STORM study, which evaluated selinexor in combination with low-dose dexamethasone on patients with penta-refractory MM.
Karyopharm also informed that the MAA has been granted an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) of the EMA. Under this procedure, the EMA’s active review time of the MAA is potentially reduced from 210 days to 150 after it is validated by the EMA. Notably, selinexor also enjoys an orphan designation for MM across the EU.
Meanwhile, the new drug application targeting an approval for selinexor in the United States is under priority review with a decision expected on Apr 6, 2019.
Shares of Karyopharm have inched up 1.7% in the past year against the industry’s decrease of 17.1%.
We remind investors that Karyopharm is also investigating selinexor in several mid- and late-stage studies for multiple cancer indications. A phase III study is analyzing the candidate in combination with Johnson & Johnson’s (JNJ - Free Report) Velcade on multiple myeloma patients.
Going forward, we expect stakeholders’ focus to remain on the potential nod for selinexor and its ensuing launch.
Zacks Rank & Other Stocks to Consider
Karyopharm currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the same sector include BioSpecifics Technologies Corp (BSTC - Free Report) and Hikma Pharmaceuticals Plc (HKMPF - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
BioSpecifics’ earnings estimates have been revised 16.8% upward for 2019 over the past 60 days. The stock has soared 44% in the past year.
Hikma’s earnings estimates have moved 6.9% north for 2019 over the past 60 days. The stock has surged 41.7% in a year.
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