FDA Grants Oncolyze Orphan Drug Designation for Leukemia Treatment

Oncolyze, a biopharmaceutical company specializing in cancer therapeutics, announced on Jan. 5, 2022, that FDA has granted the company an orphan drug designation. The designation was granted to the company’s preclinical drug candidate, OM-301, for acute myeloid leukemia (AML).

OM-301 is a therapeutic in pre-clinical development intended for the treatment of blood cancers. Acute myeloid leukemia is a rare form of cancer that has approximately 20,000 new cases each year, according to a company press release.

"We are actively fundraising to advance OM-301 into clinical trials. The orphan drug designation is an important milestone that further validates our efforts to investigate the value of OM-301 as a potentially groundbreaking therapy for patients with AML and other cancers," said Steven Evans, co-founder and CEO of Oncolyze, in the press release.