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Replimune Group Completes FDA Meeting on RP1 Application

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Replimune Group Completes FDA Meeting on RP1 Application

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Replimune Group ( (REPL) ) has issued an announcement.

On September 18, 2025, Replimune Group announced the completion of a Type A meeting with the FDA on September 16, 2025, concerning its Biologics License Application for RP1 in combination with nivolumab for advanced melanoma treatment. The company is assessing the FDA’s feedback to determine the next steps, as a path forward under the accelerated approval pathway has not yet been established. This development underscores the ongoing need for effective treatments in advanced melanoma and highlights Replimune’s commitment to working with the FDA to advance RP1.

The most recent analyst rating on (REPL) stock is a Buy with a $8.00 price target. To see the full list of analyst forecasts on Replimune Group stock, see the REPL Stock Forecast page.

Spark’s Take on REPL Stock

According to Spark, TipRanks’ AI Analyst, REPL is a Neutral.

Replimune Group’s stock score reflects its early-stage status in the biotechnology sector, characterized by significant R&D investments leading to negative earnings and cash flows. While the company shows strong equity, the current technical indicators suggest mixed to bearish market momentum. Valuation remains challenging due to negative earnings. The company’s future success hinges on the development and commercialization of its products.

To see Spark’s full report on REPL stock, click here.

More about Replimune Group

Replimune Group, Inc., headquartered in Woburn, MA, is a clinical-stage biotechnology company founded in 2015. It focuses on developing novel oncolytic immunotherapies, utilizing a proprietary RPx platform based on a potent HSV-1 backbone to maximize immunogenic cell death and induce a systemic anti-tumor immune response. The company’s product candidates are designed to be synergistic with various cancer treatment modalities.

Average Trading Volume: 9,314,480

Technical Sentiment Signal: Sell

Current Market Cap: $445.7M

For detailed information about REPL stock, go to TipRanks’ Stock Analysis page.

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