Replimune Shares Take Flight Premarket After FDA Panel Backs RP1

By Colin Kellaher

Shares of Replimune Group more than doubled in premarket trading Friday after a Food and Drug Administration advisory committee backed approval of the biotechnology company's proposed RP1 skin cancer drug.

Replimune shares, which fell 38% on Tuesday after briefing materials released ahead of the advisory committee's meeting shows the agency believes the company's data didn't show substantial evidence of the drug's effectiveness, were recently up about 128% premarket at $12.44.

The FDA panel vote marks the latest twist in the saga of Replimune's efforts to win FDA approval of RP1 in combination with Bristol Myers Squibb's blockbuster cancer drug Opdivo for advanced melanoma.

The FDA previously declined to approve Replimune's treatment in July last year and then again in April, but the agency then allowed a third submission in June and set a target action date of Aug. 2, just days after the advisory committee.

The FDA, which often turns to advisory committees to obtain advice from experts who work outside of the government when a scientific, technical or policy question arises, such as whether an unapproved product is safe and effective, usually follows the advice of the panels but isn't bound by the recommendations.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

July 31, 2026 06:34 ET (10:34 GMT)