Replimune surges after FDA advisers back skin cancer drug
REPL•FDA advisers back RP1 trial results
Replimune shares rose more than doubled premarket on Friday after the U.S. Food and Drug Administration's panel of outside advisers voted to back trial results for its drug for a type of skin cancer.
Late on Thursday, the panel voted 10 to 3 in favor of the drug, RP1, concluding that trial data showed patient benefit, despite concerns raised earlier in the week by FDA staff reviewers that trial design flaws made it unclear whether tumor shrinkage resulted from RP1 or another therapy.
"Overwhelming testimony from melanoma physicians, patients, and patient advocates made a compelling case for RP1 despite FDA criticism," said BMO Capital Markets analyst Evan Seigerman.
FDA staff concerns and prior rejection
In briefing documents released on Tuesday, FDA staff had identified several issues with the application and criteria that were used to assess the melanoma drug, concluding that these "artifactually" inflated the main goals of the trial and response rates.
Replimune shares had fallen more than 37% through Thursday's close since then. The company had a market value of about $455 million as of Thursday's close.
The FDA had declined to approve RP1 for a second time in April, citing reliance on a study without a control group, and sought more data demonstrating adequate evidence of the drug's effectiveness.
Accelerated approval decision due by August 2
Replimune is seeking accelerated approval for RP1 in combination with Bristol Myers Squibb's Opdivo for refractory or advanced melanoma in patients whose tumors progressed despite prior treatment.
"Accelerated approval for RP1 in refractory melanoma is almost certain," said Seigerman, adding a third instance where the company fails to get an FDA nod is "highly unlikely".
