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'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.
The prolonged standoff had resonated well beyond Replimune itself, crystallizing anxieties that had been building across the biotech sector. The two sides had traded sharply opposing accounts of responsibility: Replimune contended that regulators were standing in the way of a treatment physicians considered genuinely effective, whereas the FDA argued the company had simply disregarded the procedural guidance it had been given for running its trials, CNBC reported. Other pharmaceutical companies had used the case to voice wider frustrations, arguing that the agency's shifting expectations around trial design and approval standards had made drug development harder to plan.
"This constructive dialogue represents an important step forward for the thousands of patients living with advanced melanoma who have progressed on prior anti-PD-1 based therapy and have limited treatment options available to them," Replimune said in a statement.
The application is supported by data from the IGNYTE clinical trial, the company said. About 112,000 new melanoma cases and 8,510 deaths are estimated in the U.S. this year, the company said.
Replimune stock jumped as much as 82% when markets opened on Friday. Wall Street's reception was tempered by questions about what, if anything, had materially changed. Evan Seigerman of BMO Capital Markets wrote that the about-face "may reflect a desire to rectify less-popular decisions made by the FDA under Makary," while cautioning that his firm was "uncertain what has actually changed" apart from who now runs the agency, Bloomberg reported.