Replimune Stock (REPL) Soars 105% Today: Here’s Why
Replimune stock (REPL) experienced a remarkable surge of 105% in pre-market trading on Monday. This rally was triggered by the company’s announcement regarding its Biologics License Application (BLA) resubmission.
Key Developments Related to Replimune Stock
The biotechnology firm refiled its BLA for “RP1 in combination with nivolumab” aimed at treating advanced melanoma. This form of skin cancer arises from melanin-forming cells and presents significant treatment challenges.
Notably, the U.S. Food and Drug Administration (FDA) accepted the resubmission and established a Prescription Drug User Fee Act (PDUFA) target date of April 10, 2026. The resubmission followed feedback from the FDA on the initial application submitted in July 2025. The updated BLA included additional data and analyses reflecting the agency’s concerns.
Insights from Replimune’s Leadership
CEO Sushil Patel expressed optimism about the FDA’s acceptance of the resubmission. He stated, “RP1 plus nivolumab provides a compelling risk benefit profile, particularly for patients who have limited options after progressing on PD-1 based therapies.”
Stock Performance Overview
- Replimune stock rose 104% in pre-market trading.
- The previous trading day saw a 3.64% decline.
- Year-to-date, the stock has decreased by 62.84%.
- Over the past year, the shares have dropped 60.35%.
- Approximately 51 million shares traded hands on this significant news, eclipsing the three-month daily average of about 4.13 million shares.
Analysts’ Consensus on Replimune Stock
Wall Street analysts currently have a consensus rating of “Hold” for Replimune. The distribution of ratings includes:
- 2 Buy ratings
- 5 Hold ratings
- 2 Sell ratings
The average price target for REPL stock is set at $3.83, indicating a potential downside of 14.89% from current levels.
Investors are closely monitoring Replimune as it navigates the complexities of drug approval, while analysts evaluate the implications of the latest developments on stock performance.
