Replimune Shares Plummet Amid Regulatory Crisis and Mounting Litigation

Replimune Group Inc. finds itself in a severe crisis, battling significant regulatory setbacks and a growing wave of shareholder litigation. The biotechnology firm’s survival is in question following the U.S. Food and Drug Administration’s (FDA) rejection of its lead drug candidate, RP1. The situation intensifies as a critical deadline for lead plaintiff appointments in class-action lawsuits passes today.

The company’s regulatory troubles reached a new low after a Type A meeting with the FDA concluded without securing a viable path forward for RP1. The agency maintained its hardline stance, refusing to agree on any accelerated approval pathway for the cancer therapy. This decision, communicated Thursday, triggered a catastrophic intraday sell-off that erased 45% of the stock’s value in... Read more...