Biopharmaceutical company Faron Pharmaceuticals Ltd (AIM: FARN) (First North: FARON) announced on Monday that its lead candidate, bexmarilimab, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of myelodysplastic syndromes (MDS).

This designation offers clinical development benefits, including tax credits, user fee exemptions and seven years of marketing exclusivity upon FDA approval.

Bexmarilimab was also granted Orphan Drug Designation for acute myeloid leukemia (AML) by the FDA in August 2023. The drug targets the Clever-1 receptor on macrophages to reprogram myeloid cells, enhancing immune responses and sensitising cancer cells to existing treatments.

Faron is on track to report top-line efficacy results from the frontline and HMA-failed (r/r) MDS patient cohorts of its Phase I/II BEXMAB study in April 2025.