May 29 (Reuters) – Replimune said on Friday it plans to resubmit the application for its experimental skin cancer drug in the coming days after reaching an agreement with the U.S. FDA, which previously declined to approve the therapy twice.
Shares of the company jumped 77% to $8.17 in early trading.
The regulator declined to approve vusolimogene oderparepvec, also known as RP1, in April, citing reliance on a single-arm study without a control group, and asked for more data from a well-controlled trial demonstrating adequate evidence of the drug’s effectiveness.
The U.S. Food and Drug Administration’s decision to decline approval for Replimune’s drug was among a series of contentious decisions under former Commissioner Marty Makary, who stepped down earlier this month after a turbulent period marked by public disputes with drugmakers.
Makary faced criticism over reviews of potentially life-saving drugs and vaccines from Sarepta Therapeutics, uniQure and Moderna, among others.
Replimune’s shares have gained nearly 25% since Makary’s departure.
“We see this as a positive, but remain cautious as we’re uncertain what has actually changed (except FDA leadership) to warrant a different outcome,” BMO Capital analyst Evan Seigerman said, adding that “an about-face from the FDA seemingly reflects recent changes at the top of the administration.”
Replimune said on Friday that the FDA has indicated it will treat the resubmission as an urgent matter upon receipt and prioritize its review.
The company is seeking approval for RP1 in combination with Bristol Myers Squibb’s immunotherapy Opdivo for the treatment of advanced melanoma, a highly aggressive form of skin cancer.
About 112,000 new melanoma cases and 8,510 deaths are estimated in the U.S. this year, according to the company.
(Reporting by Mariam Sunny in Bengaluru; Editing by Shinjini Ganguli)
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