Replimune Holdings Inc. plans to resubmit its experimental melanoma drug for Food and Drug Administration approval, marking the company's third attempt to gain regulatory clearance for the treatment.

The FDA has previously rejected the drug twice, citing concerns about the study design used to demonstrate the treatment's effectiveness. The regulatory agency questioned whether the clinical trial methodology provided sufficient evidence to support approval.

The resubmission comes amid changes in FDA leadership, though the company has not directly linked its decision to recent personnel shifts at the regulatory agency. Replimune develops oncolytic virus immunotherapies designed to treat cancer by using modified viruses to attack tumor cells.

The melanoma treatment represents a key pipeline asset for the biotechnology company as it seeks to establish its position in the competitive cancer therapeutics market. The company will need to address the FDA's previous concerns about study design to improve its chances of regulatory approval on this third attempt.