Replimune Group, Inc. (NASDAQ:REPL) saw its stock nosedive 77% on Tuesday after the company revealed it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA), denying approval for its experimental melanoma treatment.
The regulatory setback concerns Replimune’s Biologics License Application (BLA) for RP1, which was proposed in combination with nivolumab as a treatment for advanced melanoma. In its response, the FDA determined that the supporting IGNYTE trial did not qualify as “an adequate and well-controlled clinical investigation,” and failed to deliver “substantial evidence of effectiveness.” Regulators also cited a heterogeneous patient population, which they said complicated proper interpretation of the trial data.
Further scrutiny was directed at the confirmatory trial design, with the agency raising “questions about the contribution of components.” Despite these issues, the FDA did not flag any safety concerns related to RP1 or its administration.
Replimune expressed its dismay at the outcome, particularly because the concerns laid out in the CRL had not been mentioned in previous interactions. “We are surprised by this FDA decision and disappointed for advanced melanoma patients who have limited treatment options as highlighted by the granting of breakthrough status at the time we provided the IGNYTE primary data,” said Sushil Patel, Ph.D., Chief Executive Officer of Replimune.
The company now intends to request a Type A meeting with the FDA in the coming weeks, expecting a formal response within 30 days. Replimune emphasized it would “urgently interact” with the agency to explore options for accelerated approval. However, the company warned that without such a path forward, “the development of RP1 for advanced cancer patients with limited options will not be viable.”
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