Ipsen (IPSEY) (IPSEF) shares traded higher in Paris on Wednesday after the U.S. FDA issued Breakthrough Therapy Designation for its antibody therapy IPN60340 as a treatment for acute myeloid leukemia (AML), an aggressive form of blood cancer affecting older patients.

Specifically, the designation covers the use of IPN60340 in first-line unfit AML, in combination with the chemotherapy drug azacitidine and venetoclax, a blood cancer drug marketed by AbbVie (ABBV) and Roche (RHHBY) as Venclexta.

In July 2025, the French drugmaker received Orphan Drug Designations from the FDA and the European Medicines Agency, the EU’s drug regulator, for IPN60340.

The decision on Breakthrough Therapy status was based on data from the company’s Phase I/II EVICTION trial, in which IPN60340 with Ven-Aza nearly doubled the complete responses in various solid or hematologic cancers, as well as AML, relative to historical standard-of-care data.

The FDA’s Breakthrough Therapy designation aims to expedite the development and review of treatments targeted at serious or life-threatening conditions.

With the full features of the designation, a breakthrough therapy developer can receive intensive regulatory guidance with potential eligibility for the FDA’s priority review.

Ipsen (IPSEY) (IPSEF) shares traded higher in Paris on Wednesday after the U.S. FDA issued Breakthrough Therapy Designation for its antibody therapy IPN60340 as a treatment for acute myeloid leukemia (AML), an aggressive form of blood cancer affecting older patients.

Specifically, the designation covers the use of IPN60340 in first-line unfit AML, in combination with the chemotherapy drug azacitidine and venetoclax, a blood cancer drug marketed by AbbVie (ABBV) and Roche (RHHBY) as Venclexta.

In July 2025, the French drugmaker received Orphan Drug Designations from the FDA and the European Medicines Agency, the EU’s drug regulator, for IPN60340.

The decision on Breakthrough Therapy status was based on data from the company’s Phase I/II EVICTION trial, in which IPN60340 with Ven-Aza nearly doubled the complete responses in various solid or hematologic cancers, as well as AML, relative to historical standard-of-care data.

The FDA’s Breakthrough Therapy designation aims to expedite the development and review of treatments targeted at serious or life-threatening conditions.

With the full features of the designation, a breakthrough therapy developer can receive intensive regulatory guidance with potential eligibility for the FDA’s priority review.