Replimune Group, Inc. (REPL) shares soared 82.34 percent to $8.54, up $3.86 on Friday, after the biotechnology company announced progress with the U.S. Food and Drug Administration regarding its melanoma therapy filing.
The stock is currently trading at $8.54, compared with a previous close of $4.68. It opened at $7.92 and traded between $7.67 and $9.07 during the session, with volume surging to 40.06 million shares versus average daily volume of 6.19 million shares.
Replimune Group said it reached alignment with the U.S. Food and Drug Administration on a path forward for the resubmission and reconsideration of the Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab for advanced melanoma treatment.
The company said it plans to resubmit the BLA in the coming days. The FDA indicated it would treat the resubmission as an urgent matter and prioritize the review process due to the significant unmet need among advanced melanoma patients.
Replimune shares have traded between $1.50 and $13.24 over the past 52 weeks.
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