Investing.com -- Shares of Replimune Group Inc (NASDAQ:REPL) surged more than 19% in after-hours trading following the company's announcement of significant regulatory progress for its lead product candidate, RP1 (vusolimogene oderparepvec).
The clinical-stage biotechnology firm has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration seeking accelerated approval for RP1, an oncolytic immunotherapy, in combination with nivolumab.
“We view these updates as encouraging and supportive of regulatory submission of RP1 in combination with nivolumab for anti-PD-1-failed melanoma,” said analysts at Leerink in a note.
The therapy is aimed at treating adult patients with advanced melanoma who have not responded to prior anti-PD1 therapies. Adding to the momentum, Replimune revealed that the FDA has granted Breakthrough Therapy designation to RP1 in this treatment setting.
This designation is reserved for experimental treatments showing potential for significant improvement over existing therapies based on early clinical evidence.
The nod from the FDA was awarded based on promising safety data and clinical activity observed in a subset of patients from the company’s IGNYTE trial, which focused on individuals whose melanoma had progressed despite prior anti-PD1 therapy.
As per analysts at BMO Capital Markets, investors will be closely watching for FDA approval of RP1's BLA and the subsequent Prescription Drug User Fee Act date assignment.
Beyond this, there is growing interest in RP2's clinical trials for hepatocellular carcinoma (HCC) and uveal melanoma.
The HCC trial is anticipated to commence in 2024, while the uveal melanoma trial is expected to enroll its first patient in the first quarter of 2025.