Innate Pharma (IPHA) said Monday that the US Food and Drug Administration completed a review of its confirmatory phase 3 protocol for lacutamab as a possible treatment for cutaneous T-cell lymphomas, clearing the trial to move forward.

The phase 3 trial is designed to show the efficacy of lacutamab in patients with Sezary syndrome and Mycosis fungoides who have failed at least one prior line of therapy, the company said.

The trial, set to begin in H1 2026, will include separate cohorts for patients with Sezary syndrome and mycosis fungoides, with progression-free survival as the primary endpoint, the company said.

The company said the FDA provided "encouraging initial feedback" on its proposed regulatory pathway, which could potentially include accelerated approval for the Sezary syndrome indication once the Phase 3 trial is underway.

Sezary syndrome is a rare cancer impacting the skin and blood, while mycosis fungoides is the most common type of skin cancer.

Shares of the company were up 16% in recent premarket activity.