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Replimune Stock Soars on FDA Regulatory Breakthrough

Replimune Stock Soars on FDA Regulatory Breakthrough

Author:

Global Cryptocurrency

Published:

2025-10-21 00:10:02

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BTCCSquare news:

Replimune Group's shares more than doubled in late trading Monday after the FDA accepted its resubmitted Biologics License Application for melanoma drug RP1. The regulatory green light erased concerns from June's complete response letter, with the agency setting an April 2026 decision deadline.

CEO Suhil Patel emphasized the drug's strong risk-benefit profile for advanced melanoma patients who've failed PD-1 therapy. The development marks a dramatic reversal from September's inconclusive FDA meeting, triggering a rally that dwarfed the broader market's 1.1% gain.

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