Replimune Group's stock fell over 70% following an announcement that it had received a Complete Response Letter from the U.S. Food and Drug Administration, rejecting the company’s application for its advanced melanoma therapy due to insufficient clinical evidence from Replimune's Phase 2 study.
The complaint alleges that Replimune made false and/or misleading statements and/or failed to disclose that: (1) Defendants recklessly overstated the IGNYTE trials prospects, given material issues that defendants knew or should have known of, which resulted in the FDA deeming the IGNYTE trial inadequate and not well-controlled; and (2) as a result, defendants statements about Replimune's business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all times. When the true details entered the market, the lawsuit claims that investors suffered damages.
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