Replimune’s stock fell over 70% on July 22, following an announcement that it had received a Complete Response Letter (CRL) 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 Company’s stock fell again on September 18, dropping over 40% after a Type A meeting with the FDA to discuss the CRL received in July. The Company noted that a path forward under the accelerated approval pathway remains undetermined.
A complaint has been filed against Replimune, alleging the Company made materially false and misleading statements about its IGNYTE clinical trial and the prospects for regulatory approval of RP1 in combination with nivolumab.
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