Marker Therapeutics, Inc. (NASDAQ:MRKR) shares are trading higher by 18.7% to $5.15 Monday morning after the company announced the European Medicines Agency granted MT-401 an Orphan Drug Designation.
The drug is for the treatment of patients with acute myeloid leukemia (AML). Per Marker, AML is a life-threatening disease with high relapse rates and poor outcomes after hematopoietic stem cell transplant (HSCT).
MT-401 is designed to target multiple tumor-associated antigens and is currently being evaluated in a Phase 2 clinical trial for relapsed AML post-HSCT. Orphan Drug Designation provides regulatory support, including market exclusivity, reduced fees and scientific advice from the EMA.
See Also: Why Iovance Biotherapeutics (IOVA) Shares Are Exploding Higher
Marker Therapeutics meanwhile says the company is committed to advancing MT-401 development and approval to address the significant unmet needs in AML treatment.
According to data from Benzinga Pro, MRKR has a 52-week high of $0.67 and a 52-week low of $6.60.
