FDA Feedback Clears Path to Registrational Phase III Trial for Ruxotemitide (LTX-315) in Patients with Resectable High-Risk Melanoma

Oslo, Norway, August 27, 2026 – Lytix Biopharma ASA (“Lytix” or the “Company”), a clinical-stage immuno-oncology company developing novel intratumoral cancer therapies, today announced feedback from its July meeting with the U.S. Food and Drug Administration (FDA) on the planned registrational trial of ruxotemitide (LTX-315) in combination with pembrolizumab in high-risk resectable melanoma. The FDA raised no objection to Lytix’s proposed randomized Phase III trial of neoadjuvant ruxotemitide plus pembrolizumab versus pembrolizumab alone, with event-free survival (EFS) as the primary