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Replimune Group announced plans to resubmit its application for its advanced melanoma treatment after reaching an agreement with the Food and Drug Administration on a path forward, following two prior rejections of the drug.
The company said it will resubmit the biologics license application for vusolimogene oderparepvec, also known as RP1, in the coming days. Both rejections centered on the same objection from regulators: the trial lacked a control group, leaving the FDA to insist on data from a properly controlled study before it would consider approval, Reuters reported. Replimune is seeking approval for RP1 in combination with Bristol Myers Squibb $BMY -0.11%'s immunotherapy Opdivo.
Replimune said the FDA has indicated it will treat the resubmission as an urgent matter and prioritize its review, the company said.
The resubmission comes after a significant leadership change at the FDA. At the FDA, a notable shift had already taken place: Marty Makary, whose tenure as commissioner was marked by friction with the pharmaceutical industry, had left the agency earlier this month, CNBC reported. Even before Friday's news broke, investors had already been bidding up the stock — shares were up close to 25% from the day Makary left, Reuters noted.
