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Replimune Stock Surges 105% on FDA Acceptance of Melanoma Therapy Application

Replimune Stock Surges 105% on FDA Acceptance of Melanoma Therapy Application

Author:

Global Cryptocurrency

Published:

2025-10-20 15:26:03

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BTCCSquare news:

Replimune Group Inc. (REPL) shares more than doubled after the FDA accepted its resubmitted Biologics License Application for RP1+nivolumab combination therapy in advanced melanoma. The regulatory agency set a Prescription Drug User Fee Act date of April 2026, triggering a market rally that saw the biotech firm's valuation leap.

The company addressed previous FDA concerns through additional data submissions, marking a critical milestone for the novel skin cancer treatment. CEO Sushil Patel emphasized the therapy's strong risk-benefit profile for patients failing PD-1 inhibitors, a population with limited treatment options.

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