The FDA issued a complete response letter rejecting Replimune Group’s oncolytic virus drug for advanced melanoma, citing inadequate single-arm trial design and patient heterogeneity. The agency questioned the adequacy of evidence supporting drug efficacy and raised concerns over trial design for confirmatory studies. Analyst commentary suggests evolving FDA regulatory standards may have contributed to the decision. Meanwhile, Omega Funds closed a sizable $647 million fund to support life sciences startups, reflecting ongoing investor interest despite a challenging market. Additionally, iTeos Therapeutics will be acquired by Concentra Biosciences after clinical setbacks.