Karyopharm Therapeutics Inc.'s (KPTI - Free Report) 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 industry’s decrease of 2.2%.
We remind investors that Karyopharm is also evaluating selinexor in several mid- and later-phase studies on multiple cancer indications, the most advanced being the phase III study of the candidate in combination with Johnson & Johnson’s (JNJ - Free Report) Velcade on multiple myeloma patients. The company is also planning to evaluate Selinexor on subjects with gynecological malignancies.
Notably, last October, Karyopharm entered into an exclusive license agreement with the Japanese company Ono Pharmaceutical for developing and commercializing selinexor for all human oncology indications in Japan, South Korea, Taiwan, Hong Kong and the 10 Southeast Asian countries.
Going forward, we expect investor’s focus to remain on the company’s further updates on selinexor.
Zacks Rank & Key Picks
Karyopharm carries a Zacks Rank #4 (Sell).
Two better-ranked stocks in the health care sector are Ligand Pharmaceuticals Incorporated (LGND - Free Report) and Infinity Pharmaceuticals, Inc. (INFI - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Ligand’s earnings per share estimates have moved up from $3.78 to $4.20 for 2018 and from $4.75 to $5.32 for 2019 in the last 60 days. The company delivered a positive surprise in three of the trailing four quarters with an average beat of 24.88%. Share price of the company has soared 54.6% over a year.
Infinity’s loss per share estimates narrowed from $1.07 to 74 cents for 2018 and from 83 cents to 66 cents for 2019 in the last 30 days. The company delivered a positive surprise in three of the trailing four quarters with an average beat of 7.87%.
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