The shares of the commercial-stage biotech, Karyopharm Therapeutics (NASDAQ:KPTI) have lost ~28% in the pre-market Wednesday amid concerns that the company will need another trial to support its request for U.S. label expansion of cancer therapy, Xpovio (selinexor).
Following a meeting with the U.S. Food and Drug Administration (FDA), the company has learned that topline results of its ongoing Phase 3 trial SIENDO are unlikely to support the supplemental New Drug Application ((sNDA)) for the therapy in endometrial cancer.
The 263-patient trial was designed to assess selinexor as a front-line maintenance therapy after chemotherapy in advanced or recurrent endometrial cancer.
“The Company will continue to collect and analyze the SIENDO study data and work with the FDA to explore all regulatory pathways for patients with p53 wild-type,” Karyopharm (KPTI) said in a statement.
However, in light of the regulatory feedback, the company plans to immediately start another trial this year for selinexor targeting patients with p53 wild-type endometrial cancer. Its topline data are expected in H1 2024.
Commenting on the development, H.C. Wainwright analyst Edward White, who has a Buy rating on Karyopharm (KPTI), has lowered the price target to $23 from $26 to imply a premium of ~121% to the last close.
The analyst expects, Xpovio, currently approved in the U.S. for certain patients with multiple myeloma and B–cell lymphoma, will be launched for solid tumors in 2025.