Can Karyopharm’s Myeloma Treatment Selinexor Pass Muster?
Karyopharm shares jumped on Friday after the firm announced an FDA update from the FDA on its treatment for myeloma.
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Karyopharm Therapeutics Inc. (NASDAQ: KPTI) shares jumped on Friday after the firm announced an update from the U.S. Food and Drug Administration (FDA).
Specifically, the FDA has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for Karyopharm’s selinexor. The NDA, which is currently under Priority Review by the FDA, is seeking accelerated approval for selinexor.
The previously disclosed April 6, 2019, PDUFA date has been extended by three months to July 6, 2019.
Selinexor, in combination with dexamethasone, is a treatment for patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one anti-CD38 monoclonal antibody.
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While the extension of the PDUFA date might be seen as a mixed blessing, the FDA’s Oncologic Drugs Advisory Committee met late February to discuss the selinexor NDA and voted eight to five recommending that the FDA wait for the results from Karyopharm’s Phase 3 study before making a final decision regarding approval.
Although the FDA considers the recommendation of this panel, the final decision regarding the approval of the product is made by the FDA solely, and the recommendations by the panel are non-binding.
Shares of Karyopharm were last seen up about 15% at $5.06 on Friday, in a 52-week range of $3.92 to $21.71. The stock has a consensus price target of $15.78.
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Chris Lange is a financial and geopolitical writer with more than a decade of experience covering a myriad of topics. He has published thousands of articles for 24/7 Wall St., with past coverage focused heavily on stocks, IPOs, healthcare, defense, global affairs, and technology.
His work has been quoted, or referenced by a number of outlets including Business Insider, USA Today, Yahoo Finance, MSN, The Motley Fool, and many other publications. A graduate of Southwestern University, he studied business with a focus on investments and has previous experience in banking and startups.
When not reading or writing the news, he is following his passion for Lacrosse, playing chess, or building solar projects with his dad.
