Class Action Lawsuit Filed Against Replimune Group Following FDA's BLA Denial
Pomerantz Law Firm has filed a class action lawsuit against Replimune Group, Inc. (NASDAQ: REPL), alleging securities fraud and other unlawful business practices involving its officers or directors. The firm is urging investors who purchased shares during the specified Class Period to contact them ahead of an October 5, 2026 deadline for seeking appointment as Lead Plaintiff. The lawsuit follows a Complete Response Letter from the FDA on April 10, 2026, rejecting Replimune's Biologics License Application (BLA) for RP1 in combination with nivolumab. The agency cited deficiencies in clinical trials and noted that data submitted was insufficient to meet regulatory approval standards. This led to a sharp decline in the company’s stock price. Replimune responded by issuing a press release after market close on April 10, acknowledging FDA concerns but suggesting there might be pathways for accelerated approval based on compelling single-arm trial results. Despite this, its share price continued to fall significantly over subsequent days.
Tickers: $REPL
Topics: biologics license application class action fda rejection securities fraud