---
title: "Why Is Replimune Stock (REPL) Up 105% Today?"
description: "Replimune's stock surged 105% after the FDA accepted its resubmission of the BLA for RP1, with a PDUFA date set for April 10, 2026. The company addressed FDA feedback and believes it has provided a co"
type: "news"
locale: "en"
url: "https://longbridge.com/en/news/261898215.md"
published_at: "2025-10-20T13:19:30.000Z"
---

# Why Is Replimune Stock (REPL) Up 105% Today?

> Replimune's stock surged 105% after the FDA accepted its resubmission of the BLA for RP1, with a PDUFA date set for April 10, 2026. The company addressed FDA feedback and believes it has provided a complete response. CEO Sushil Patel expressed optimism about expediting the review for advanced melanoma treatment. Despite today's gains, Replimune's stock has fallen 62.84% year-to-date and 60.35% over the past year, with heavy trading volume of 51 million shares compared to a three-month average of 4.13 million.

Replimune noted that the U.S. Food and Drug Administration (FDA) accepted its resubmission of the BLA and has set a PDUFA date of April 10, 2026. The biotechnology company has worked over the past few months to address feedback from the FDA on its initial BLA submission. As a result, it included additional information, data, and analyses in the resubmission. It considers this a complete response to the FDA's complete response letter sent in July 2025.

Replimune CEO Sushil Patel said, "We are pleased the agency has accepted the resubmission of our BLA for RP1. RP1 plus nivolumab offers a strong risk benefit profile where there are few options for patients with advanced melanoma, who have progressed on PD-1 based therapy. We look forward to working closely with the agency to expedite this review as much as possible for patients' benefit."

## **Replimune Stock Movement Today**

Replimune stock was up 104% in pre-market trading on Monday, following a 3.64% drop yesterday. The shares have fallen 62.84% year-to-date and 60.35% over the past 12 months. Today's news came with heavy trading, as some 51 million shares changed hands, compared to a three-month daily average of about 4.13 million units.

### Related Stocks

- [REPL.US - Replimune](https://longbridge.com/en/quote/REPL.US.md)

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> **Disclaimer**: This article is for reference only and does not constitute any investment advice.