Replimune (REPL) stock took off on Friday after the company provided investors with an update on RP1. The biotechnology company received a positive outcome from the U.S. Food and Drug Administration’s (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee following a review of its BLA resubmission for RP1. This is a cancer immunotherapy candidate being developed with nivolumab for advanced melanoma patients who have failed prior anti-PD-1 treatment.
The FDA committee reviewed whether the IGNYTE study could provide a reliable measure of response rate and durability, as well as whether the results showed meaningful clinical benefit and evidence of systemic anti-tumor activity from RP1. The panel voted 10 to 3 that the efficacy results from IGNYTE were evaluable and clinically meaningful.
“We are encouraged by today’s outcome and would like to thank the committee for its thoughtful discussion of the IGNYTE data,” said Replimune CEO Sushil Patel. “This is an important step forward for patients with advanced melanoma who have progressed on anti-PD-1 therapy.”
The FDA is expected to make its decision on the Biologics License Application (BLA) resubmission by August 2, 2026, under a Class 1 resubmission review.
Analysts Upgrade REPL Stock Following the FDA Update
Replimune stock received upgrades from a few analysts in light of the FDA committee’s positive stance on RP1.
- Cantor Fitzgerald analyst Li Watsek upgraded the stock to a Buy but provided no price target for the shares.
- Four-star Wedbush analyst Robert Driscoll upgraded REPL stock to a Buy rating and increased his price target to $12 from $9, suggesting a possible 11.52% upside for the shares.
- Five-star Piper Sandler analyst Allison Bratzel upgraded REPL stock to a Buy rating and kept a $14 price target, implying a 30.11% upside for the shares.
- Additionally, five-star BMO Capital analyst Evan Seigerman reiterated a Buy rating and a $16 price target for REPL stock.
What Does the FDA News Mean for REPL Stock?
The FDA update was an immediate benefit for Replimune stock, as the company’s shares rallied 96.3% on Friday. This extended a 9.26% year-to-date rally, though the shares were still down 28.82% over the past 12 months.
With today’s news came heavy trading of REPL stock, as some 19 million shares changed hands. For comparison, the stock’s three-month average daily trading volume was about 3.05 million shares.
Investors will also want to keep a close eye on REPL stock in the days to come. With the FDA’s resubmission decision deadline set for August 2, 2026, shares of REPL stock could see more volatility and trading activity when markets open on Monday. (See REPL Stock Forecast)