Replimune Group Inc. (REPL) announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for RP1 in combination with nivolumab for the treatment of advanced melanoma.
The company stated that it disagreed with the FDA's assessment of the data set, which had previously supported the breakthrough therapy designation. Replimune emphasized that it believes the evidence is sufficient to allow this promising medicine to be made available to patients with advanced cancer.
In July 2025, the FDA issued the CRL, marking a significant development in the regulatory path for RP1 and raising questions about the next steps for advancing this therapy in melanoma treatment.
On April 10, REPL closed regular trading at $4.76, down $1.15 or 19.46%. In after-hours trading the same day, the stock dropped further by $3.01, a decline of 63.24%, bringing it to $1.75.
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