Karyopharm Therapeutics (NASDAQ:KPTI) stock is climbing higher on Tuesday after getting fast-track designation for its myelofibrosis treatment.
The U.S. Food and Drug Administration (FDA) has granted fast-track designation to the development of selinexor. This treatment is focused on patients suffering from primary myelofibrosis, post-essential thrombocythemia myelofibrosis and post-polycythemia vera myelofibrosis.
Fast-track designation will offer Karyopharm Therapeutics certain advantages as it further develops selinexor. That includes easier access to the FDA for meetings as well as more frequent meetings with the regulator.
Karyopharm Therapeutics notes that it launched a Phase 3 clinical trial of selinexor last month. The company says it expects data from that clinical trial to be available sometime in 2025.
Reshma Rangwala, MD, PhD, Chief Medical Officer of Karyopharm Therapeutics, said the following about the fast-track news:
“Selinexor’s unique mechanism of action, XPO1 inhibition, is a novel and potentially fundamental mechanism in myelofibrosis. We have been highly encouraged by the efficacy and safety data observed to date [in our Phase 1 study] with selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis and believe selinexor has the potential to shift the treatment paradigm.”
How This Affects KPTI Stock
Investors are buying up shares of KPTI stock today alongside the fast-track designation news. As such, shares are seeing heavy trading. That has some 6.5 million shares changing hands as of this writing. For the record, the stock’s daily average trading volume is about 2.8 million shares.
KPTI stock is up 20.9% as of Tuesday morning.
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On the date of publication, William White did not hold (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
