Lytix Biopharma Receives Positive US FDA Feedback for Melanoma Therapy's Late-stage Study

01:40 AM EDT, 08/27/2026 (MT Newswires) -- Lytix Biopharma (LYTIX.OL) said Thursday it received "constructive feedback" from the US Food and Drug Administration for its planned registrational late-stage trial of ruxotemitide combination therapy for high-risk resectable melanoma. During a July meeting, the regulator raised no objections to the proposed randomized phase 3 trial of neoadjuvant ruxotemitide plus pembrolizumab versus pembrolizumab alone, the clinical-stage immuno-oncology company said. The primary endpoint of the study will be event-free survival. A single well-controlled trial could also support a new drug application depending on the totality of the data generated, the regulator confirmed.