Biotech Replimune more than doubles after FDA panel OKs skin cancer treatment

Shares of small-cap biotech Replimune Group soared 107% on Friday. The company announced that an advisory committee to the U.S. Food and Drug Administration had found the results of a study of its experimental melanoma treatment to be “evaluable and clinically meaningful.” The FDA has already twice rejected the biotech’s application for accelerated approval of the therapy. Wall Street now believes the chances of a favorable outcome are significantly higher.

Replimune jumped 107% on the Nasdaq on Friday to $11.20 per share. The previous evening, the company said an FDA advisory committee had voted that the results of a study of its experimental melanoma treatment were “evaluable and clinically meaningful.” The FDA must now decide whether to approve the treatment. It could announce its decision as soon as this weekend, according to the company’s press release.

Replimune has been trying for more than a year to secure approval for its experimental treatment for melanoma patients whose disease has progressed following previous therapy. The treatment is based on a genetically modified strain of the herpes simplex type 1 virus. It is injected directly into tumors and used in combination with another drug made by Bristol Myers Squibb.

In 2024, the FDA granted the treatment Breakthrough Therapy designation, allowing the company to seek accelerated approval without completing every stage of clinical testing.

However, in July 2025, the FDA rejected Replimune’s accelerated approval application, saying the company had not provided sufficient evidence of the treatment’s effectiveness. The company resubmitted the application but was rejected again in April because the FDA considered the data insufficient. Among other concerns, regulators objected to the heterogeneity of the study population. The biotech disagreed with the decision, describing the decision-making system as ineffective and a threat to innovation. The FDA advisory committee, however, concluded that the data provided by the company allowed the treatment’s efficacy results to be evaluated.

Following the FDA advisory committee vote, Wedbush analyst Robert Driscoll upgraded his rating on Replimune to “outperform” from “neutral” on Friday, Barron’s reports. He also raised his target price by 33% to $12 per share, implying 7% upside from Friday’s closing price.

Driscoll noted that while the FDA had repeatedly raised concerns about shortcomings in the treatment study’s design, he believed that the strength of the efficacy signals persuaded the advisory panel’s melanoma specialists to vote in favor.

Cantor Fitzgerald also upgraded Replimune shares to “overweight” from “neutral,” Barron’s reported. The firm wrote that the “overwhelmingly positive” outcome, together with “compelling” testimony from patients and physicians at the meeting, materially increased the likelihood that the FDA would grant accelerated approval for the treatment.

The stock has five “buy” calls from Wall Street versus one “hold.” Three months ago, the picture was radically different: it had one “buy,” four “hold,” and three “sell” ratings. The average target price is currently $14 per share, implying 25% upside from the last close.