Replimune Shares Signal Potential Rebound Following Key Developments

A significant shift appears underway for Replimune Group Inc. as two major catalysts converge, potentially reversing its prolonged downward trajectory. The biopharmaceutical company is gaining fresh momentum from an analyst rating upgrade by BMO Capital, coinciding with a critical regulatory milestone for its lead cancer therapy, RP1.

In a pivotal development for the company, the U.S. Food and Drug Administration has formally accepted Replimune's resubmitted Biologics License Application for RP1. This acceptance marks a substantial recovery from the setback experienced in July 2025, when the regulatory agency issued a Complete Response Letter rejecting the original submission. The FDA's previous rejection cited concerns that the IGNYTE clinical trial lacked sufficient control measures. The newly submitted application directly addresses these criticisms with additional supporting data, establishing April 10, 2026, as the updated target date for the FDA's final decision.

Market Sentiment Shifts as Analysts Revise Positions

The investment community is demonstrating renewed confidence in Replimune's prospects. BMO Capital has elevated its assessment from "Underperform" to "Market Perform," while Leerink Partners has implemented a more substantial upgrade. The latter firm boosted its rating from "Market Perform" to "Outperform" and simultaneously increased its price target dramatically from $3.00 to $13.00. Meanwhile, HC Wainwright continues to maintain its "Buy" recommendation with a $12.00 price objective, despite implementing a minor adjustment to its Q2 2026 earnings estimate.

Should investors sell immediately? Or is it worth buying Replimune?

Current market indicators reflect this growing optimism:

• Brokerage consensus rating stands at "Moderate Buy"
• The average price target across analysts is $9.75
• Key FDA decision date set for April 10, 2026
• Most bullish projections reach as high as $13.00

The FDA's acceptance of the resubmitted application represents a potential inflection point for Replimune. Following extended uncertainty surrounding the company's flagship product, investors now have clearer visibility into the regulatory timeline, prompting market experts to rapidly reassess their positions based on these improved circumstances.