Replimune to Resubmit Melanoma Drug as FDA Shift Sends Shares Up 70%
Updated
Updated · CNBC · May 29
Replimune to Resubmit Melanoma Drug as FDA Shift Sends Shares Up 70%
1 articles · Updated · CNBC · May 29
Replimune said it will resubmit its melanoma drug application to the FDA in the coming days after reaching agreement with the agency on a path forward.
The FDA indicated it will treat the filing as urgent and prioritize its review, a sharp turn after rejecting the treatment twice under previous leadership.
Former Commissioner Marty Makary stepped down earlier this month, and the dispute had become a flashpoint for industry complaints about inconsistent FDA guidance on trials and experimental-drug approvals.
Replimune had argued the agency wrongly blocked a promising option for advanced melanoma patients who have progressed on anti-PD-1 therapy, while the FDA said the company ignored trial guidance.
Replimune shares jumped as much as 70% in premarket trading Friday; the company was valued at $386 million at Thursday's close.
Will a simple leadership change at the FDA be enough to approve a twice-rejected cancer drug?
Is this drug's revival a win for patients or a warning about regulatory pressure on the FDA?