Karyopharm Shares Soar On FDA Fast Track Status, EU Orphan Medicinal Product Status To Preleukemia Candidate

The U.S. Food and Drug Administration (FDA) has granted fast track designation to Karyopharm Therapeutics’ KPTI lead asset Eltanexor as monotherapy for the treatment of patients with relapsed or refractory Myelodysplastic Syndromes (MDS).

Eltanexor is being evaluated in an ongoing open-label Phase 1/2 study in patients with relapsed/refractory MDS.

Richard Paulson, President and Chief Executive Officer, commented : "These recent designations from the FDA and EC reinforce eltanexor's potential to improve clinical outcomes for patients with relapsed/refractory MDS. We are dedicated to advancing our ongoing clinical trials and remain committed to bringing eltanexor to these patients and their families as a new treatment option.”

FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.

Additionally, the European Commission (EC) adopted the Committee for Orphan Medicinal Products (COMP) opinion to designate Eltanexor as an orphan medicinal product for the treatment of MDS in the European Union (EU).

Orphan Medicinal Product Designation is granted by the European Commission to promote the development of drugs that target rare (less than 5 in 100,000 people across the European Commission), seriously debilitating and/or life-threatening diseases, and are expected to provide a significant benefit over existing authorized treatments.

Price Action : Karyopharm shares are trading around 7 percent higher at $5.00 on Wednesday at the time of publication.