Biotech Stocks Facing FDA Decision In July 2019

Karyopharm Therapeutics
Karyopharm Therapeutics

The FDA decision on Karyopharm Therapeutics Inc.’s (KPTI) New Drug Application seeking accelerated approval for Selinexor in combination with Dexamethasone as a new treatment for patients with triple class refractory multiple myeloma is expected on July 6, 2019.

The Company is seeking accelerated approval for Selinexor based on findings from Part 2 of phase IIb study, dubbed STORM, which showed that the combination of Selinexor and Dexamethasone elicited a 26.2% overall response rate (ORR) and an 8.6-month median overall survival (OS).

In February of this year, an FDA panel, which reviewed the Selinexor NDA voted 8 to 5 against the accelerated approval, and recommended that the approval decision for Selinexor should be delayed until the results of a phase III study, dubbed BOSTON, are available.

The phase III BOSTON study is underway, and top-line data is expected by the end of 2019 or 2020.

KPTI closed Tuesday’s (June 25, 2019) trading at $5.89, down 7.10%.