Can Karyopharm's Myeloma Treatment Selinexor Pass Muster?
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.
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.