BMY
REPL
A very expensive “maybe”
Replimune just caught a big break. An FDA advisory committee voted 10-3 that the company’s IGNYTE data for RP1 plus Bristol Myers Squibb’s Opdivo looked clinically meaningful and evaluable, which sent REPL ripping more than 100% higher.
That’s not the same thing as approval. But in biotech, a favorable panel vote is basically the market’s version of hearing, “okay, maybe don’t throw the whole project into the sun just yet.”
Why investors suddenly care again
The whole RP1 story has been a roller coaster. The FDA previously slammed the company’s application, saying the single-arm mid-stage study wasn’t interpretable, and even issued a Complete Response Letter in June 2025.
Now the agency’s target action date for the Class 1 resubmission is August 2, 2026. So this panel vote matters because it could swing the odds on whether Replimune gets a real shot at turning its melanoma program into a commercial asset.
The Bristol Myers connection
BMY shows up here because Opdivo is part of the combo. That makes Bristol Myers a material counterpart in the story, even though the stock pop is all Replimune’s.
Meanwhile, Capricor got the opposite treatment from the same general FDA backdrop, but that’s just context — the market loves a good biotech contrast story almost as much as it loves a moonshot chart.
Big picture: Replimune is still not home free, but after this vote, the company went from “yikes” to “maybe there’s a path.” In biotech, that’s often enough to move a stock like a rocket with a loose bolt.