Replimune Group, Inc. announced its financial results for the fiscal first quarter ended June 30, 2025, and provided a corporate update on August 7, 2025. The company acknowledged the U.S. Food and Drug Administration (FDA) had issued a Complete Response Letter (CRL) for the RP1 Biologics License Application (BLA) in advanced melanoma on July 22, 2025.
CEO Sushil Patel stated that Replimune is committed to finding an expeditious path forward with the FDA, citing the compelling clinical data and safety profile generated to date with RP1 in the IGNYTE study. The company believes RP1 should be made available to patients with few remaining treatment options.
Based on the current operating plan, Replimune believes its existing cash, cash equivalents, and short-term investments as of June 30, 2025, will fund operations into the fourth quarter of 2026. This projection includes potential commercialization of RP1 in skin cancers and excludes any potential revenue.
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