Karyopharm Therapeutics Inc. (NASDAQ: KPTI) shares made a handy gain on Wednesday after the firm secured a key U.S. Food and Drug Administration (FDA) approval for its relapsed or refractory diffuse large B-cell lymphoma treatment.
The investor reaction to this announcement is not huge, but keep in mind that shares are up 77% in the past 52 weeks. Karyopharm was only a $4 stock in March of 2019.
The FDA announced that it has accepted for filing the supplemental New Drug Application (sNDA) seeking accelerated approval for oral Xpovio (selinexor) tablets. The FDA also granted Karyopharm’s request for Priority Review and assigned a user fee goal date of June 23, 2020, under the Prescription Drug User-Fee Act (PDUFA).
Given that the marketing approval will be granted by the FDA, Karyopharm plans to commercialize Xpovio in the United States in this second indication by mid-2020. The company also expects to submit a Marketing Authorization Application to the European Medicines Agency in 2020, requesting conditional approval for Xpovio in this same indication.
PDUFA dates are granted by the FDA to drugs that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of a serious condition when compared to standard applications. Xpovio has received both Orphan Drug and Fast Track designations from the FDA for the treatment for patients with relapsed or refractory diffuse large B-cell lymphoma.
Sharon Shacham, Ph.D., MBA, founder, president and chief scientific officer of Karyopharm, said:
We look forward to supporting the FDA through the review process for our second NDA for Xpovio as there remains significant unmet medical need for patients whose DLBCL has relapsed or is refractory to multiple drug therapies. This regulatory milestone for Xpovio represents another important step towards bringing a novel, oral treatment option with a unique mechanism of action to patients and families in need.
Karyopharm stock traded up about 2% to $16.65 Wednesday morning, in a 52-week range of $3.92 to $20.09. The consensus price target is $25.86.