May 29 (Reuters) – Replimune said on Friday it plans to apply a third time for approval of its experimental skin cancer drug in the coming days after reaching an agreement with the U.S. regulator.
Shares of the company rocketed 86% for the day to $8.69.
The FDA 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. It had rejected an initial application last year.
After last month’s rejection, the Wall Street Journal reported on Friday, Replimune met in early May with the White House, which then pushed health officials to re-examine the FDA’s repeated rejections of the advanced melanoma treatment.
The company told the White House the FDA’s action was at odds with the Trump administration’s desire to help terminally ill patients, the Journal said, citing unidentified people familiar with the matter.
The White House and the FDA did not immediately respond to requests from Reuters for comment on the newspaper report outside business hours. The Journal said the White House declined to comment.
The regulator’s second rejection of Replimune’s melanoma drug was among a series of contentious decisions under then-Commissioner Marty Makary, who stepped down 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 said the FDA has indicated it would treat the resubmission as an urgent matter and prioritize its review.
BMO Capital analyst Evan Seigerman said Replimune’s decision to reapply was positive but that the bank remained “cautious as we’re uncertain what has actually changed (except FDA leadership) to warrant a different outcome,” adding that “an about-face from the FDA seemingly reflects recent changes at the top of the administration.”
Replimune 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; Additional reporting by Mihika Sharma; Editing by Shinjini Ganguli and William Mallard)
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