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.

Disclaimer:This article represents the opinion of the author only. It does not represent the opinion of Webull, nor should it be viewed as an indication that Webull either agrees with or confirms the truthfulness or accuracy of the information. It should not be considered as investment advice from Webull or anyone else, nor should it be used as the basis of any investment decision.