Innate Pharma shares surge 34.63% after-hours as FDA clears Phase 3 trial for lacutamab in CTCL.

Innate Pharma surged 34.63% in after-hours trading following FDA clearance to initiate its Phase 3 TELLOMAK 3 trial for lacutamab in cutaneous T-cell lymphoma (CTCL). The regulatory green light allows the company to proceed with a randomized, open-label study comparing lacutamab to established therapies like romidepsin and mogamulizumab in Sézary syndrome and Mycosis fungoides. The FDA’s no-objection review of the trial protocol and its encouraging feedback on a potential accelerated approval pathway for Sézary syndrome underscored the milestone’s significance. Positive Phase 2 data demonstrating lacutamab’s durability, safety, and quality-of-life improvements further reinforced optimism. The trial’s initiation in H1 2026 positions Innate Pharma to advance toward regulatory submissions, with Fast Track, Breakthrough Therapy, and Orphan Drug designations amplifying the drug’s commercial potential in a high-growth, underserved market. Analyst upgrades and coverage from H.C. Wainwright and Lucid Capital also contributed to the momentum, but the FDA clearance emerged as the primary catalyst for the sharp post-market rally.