FDA grants Ipsen’s IPN60340 Breakthrough status

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for French drugmaker Ipsen’s (Euronext: IPN) IPN60340 in combination with venetoclax and azacitidine (Ven-Aza) in first line unfit acute myeloid leukemia, an aggressive blood cancer affecting older adults.

IPN60340 is an investigational first-in-class monoclonal antibody targeting BTN3A, a key immune-regulatory molecule broadly expressed across cancer. Ipsens’ shares rose 5.6% to 134.6 euros this morning following the announcement Late Tuesday.

Breakthrough Therapy Designation is intended to expedite the development and review of medicines for serious or life-threatening conditions with evidence of a substantial clinical improvement. IPN60340 previously received Orphan Drug Designations from the U.S. Food and Drug Administration and European Medicines Agency in July 2025.