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Replimune Group, Inc.
As of May 30, 2026 at 24:05 UTC
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About Replimune Group, Inc.
Replimune Group Inc is a clinical-stage biotechnology company. It uses a proprietary RPx platform to design and develop product candidates that are intended to maximally activate the immune system against solid tumors. The RPx platform is based on a proprietary, engineered strain of herpes simplex virus 1, or HSV-1, backbone with payloads added to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The company focuses on developing oncolytic immunotherapies for the treatment of cancer. Its pipeline products include RP1, RP2, and RP3. The company operates in USA and UK, majority of revenue from USA.
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Latest News
5 articlesThe Schall Law Firm is investigating Replimune Group, Inc. for potential securities law violations related to allegedly false or misleading statements. The company received a complete response letter from the FDA regarding its BLA for RP1 in combination with nivolumab for advanced melanoma treatment, citing disagreement over data suitability. Following this announcement on April 10, 2026, Replimune's stock price fell approximately 64.3% on April 13, 2026.
The global oncolytic virus immunotherapy market is projected to reach over $5 billion by 2031, with three approved therapies and more than 150 candidates in clinical trials. Major pharmaceutical companies and biotechnology firms are advancing combination therapies and strategic partnerships to address cancer treatment challenges, with significant clinical development underway across multiple indications.
Replimune announced it received a Complete Response Letter (CRL) from the FDA for its RP1 biologics license application in combination with nivolumab for advanced melanoma treatment. Despite the drug showing a 34% response rate with 24.8-month median duration in the IGNYTE trial, the FDA rejected approval. The company criticized the FDA's regulatory process and announced it will scale back operations and eliminate jobs, stating the treatment will not be available to patients due to systemic failures rather than drug efficacy.
The global oncolytic virotherapy market is projected to grow from USD 49.73 million in 2025 to USD 153.31 million by 2031, with a CAGR of 20.64%. Growth is driven by rising cancer incidence, advances in genetic engineering, and synergistic combination therapies with checkpoint inhibitors. However, host immune system challenges and premature viral clearance remain significant obstacles to market expansion.
Replimune presented biomarker data showing RP1 plus nivolumab can potentially reverse resistance mechanisms to PD-1 blockade in advanced melanoma, demonstrating a 33.6% response rate and 24.8-month median response duration.