Shares of Karyopharm Therapeutics Inc. (KPTI - Free Report) were up almost 7.1% after the company announced that the FDA has extended its action date for the new drug application (NDA) of oral selective inhibitor of nuclear export (SINE) compound, selinexor, by three months. The company is looking to get an accelerated approval for the candidate to treat patients with relapsed-refractory multiple myeloma (MM), who have received at least three prior lines of therapy.
Previously, the regulatory body was expected to render its decision on Apr 6, 2019. However, the FDA delayed its verdict by three months and has now set an action date of Jul 6 this year.
However, shares of Karyopharm have plunged 49.7% so far this year against the industry’s increase of 19.1%.
The FDA delaying its decision on the NDA is normally seen as a major setback for any company and should ideally affect the stock negatively. However, it’s a paradox that the stock is up despite such unfavorable news.
In February 2019, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 8-5, recommending that the regulatory body should wait for the results from Karyopharm’s phase III BOSTON study before making a final decision on selinexor. The study data is expected by this year-end at the earliest or by 2020.
If the FDA had followed ODAC’s recommendation, the approval for selinexor would not have then come before 2019 end or early 2020. With the FDA now likely to convey its verdict in July, investors cheered this development.
However, Karyopharm amended the NDA by submitting additional clinical information on the same as the FDA had requested extra existing information for review. This, in turn, ensured the FDA to defer the action date by three months. The regulatory agency could have rejected the NDA altogether following the advisory committee’s vote to postpone its decision on the same.
Selinexor is also under review in the EU for treating patients with penta-refractory multiple myeloma (MM). The candidate also enjoys a Fast Track designation and an orphan drug status for MM in the United States.
Karyopharm is also evaluating selinexor in several mid- and later-phase studies for multiple cancer indications, the most advanced being the phase III program of the candidate in combination with Takeda’s Velcade for treating patients with MM.
Karyopharm Therapeutics Inc. Price
Zacks Rank & Stock to Consider
Karyopharm currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks from the same space are AIT Therapeutics, Inc. (AITB - Free Report) , Lannett Co Inc (LCI - Free Report) and Infinity Pharmaceuticals, Inc. (INFI - Free Report) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
AIT Therapeutics’ loss per share estimates have been narrowed 18.8% for 2019 in the last 60 days. The stock has gained 6.2% year to date.
Lannett’s earnings estimates have been revised 1.9% upward for 2019 over the past 60 days. The stock has soared 65.2% in the year so far.
Infinity Pharmaceuticals’ loss per share estimates have been narrowed 8.1% for 2019 in the last 60 days. The stock has rallied 52.6% so far this year
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