tiprankstipranks
Trending News
More News >
Advertisement
Advertisement

Replimune Group Receives FDA Complete Response Letter

Story Highlights
Replimune Group Receives FDA Complete Response Letter

Elevate Your Investing Strategy:

  • Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.

The latest announcement is out from Replimune Group ( (REPL) ).

On July 21, 2025, Replimune Group received a Complete Response Letter from the FDA regarding its Biologics License Application for RP1 in combination with nivolumab for treating advanced melanoma. The FDA cited inadequacies in the IGNYTE trial’s design and patient population heterogeneity, though no safety issues were noted. Replimune plans to engage with the FDA to address these concerns and seek a path forward for RP1’s approval, emphasizing the potential benefits for patients with limited treatment options.

The most recent analyst rating on (REPL) stock is a Buy with a $17.00 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 focused on developing novel oncolytic immunotherapies. Founded in 2015, the company aims to transform cancer treatment through its proprietary RPx platform, which is designed to maximize immunogenic cell death and induce a systemic anti-tumor immune response. The platform is based on a potent HSV-1 backbone and is intended to be synergistic with various cancer treatment modalities.

Average Trading Volume: 1,574,542

Technical Sentiment Signal: Buy

Current Market Cap: $932M

See more insights into REPL stock on TipRanks’ Stock Analysis page.

Disclaimer & DisclosureReport an Issue

Looking for investment ideas? Subscribe to our Smart Investor newsletter for weekly expert stock picks!
Get real-time notifications on news & analysis, curated for your stock watchlist. Download the TipRanks app today! Get the App
1