Why Is REPL Stock Gaining In Pre-Market Today?

• Replimune observed tumor shrinkage in both injected and non-injected lesions.
• RP2 achieved a 19% response rate when used alone, while the combination of RP2 and Nivolumab produced a 19.1% response rate.
• The biotech firm is expected to post a loss of $0.72 per share for the fourth quarter, according to Fiscal.ai data.

Shares of Replimune Group (REPL) soared 13% in pre-market trading on Monday as investors looked ahead to the company’s fourth-quarter results, buoyed by encouraging early clinical data for its cancer immunotherapy RP2 and fresh momentum from last week’s pivotal FDA agreement involving its lead therapy, RP1.

If pre-market gains hold, REPL shares would reach their highest level of the year. The stock also posted its biggest one-day jump in more than seven months on Friday after the company reached an agreement with the FDA to resubmit its marketing application for its lead skin cancer therapy, which had previously faced two regulatory setbacks.

RP2 Trial Shows Tumor Regression

The study enrolled 85 heavily pretreated patients with advanced solid tumors, including uveal melanoma, colorectal cancer, head and neck cancer, pancreatic cancer, melanoma, and sarcoma.

Replimune observed tumor shrinkage in both injected and non-injected lesions, suggesting RP2 can trigger a systemic anti-tumor immune response.

The analysis also showed that the therapy helped transform immunologically ‘cold’ tumors, those largely ignored by the immune system, into more immune-active tumors that could be more readily recognized and targeted. It also boosted key immune responses that fight cancer.

RP2 achieved a 19% response rate when used alone, while the combination of RP2 and Nivolumab produced a similar 19.1% response rate and maintained disease control in nearly 49% of patients.

FDA Leadership Changes Reignite Hope

On Friday, the FDA said it will prioritize the review of Replimune’s application, citing the lack of treatment options for patients with advanced melanoma. The decision comes after the agency rejected the filing twice, in July 2025 and April 2026.

The agreement also comes shortly after leadership changes at the FDA, which included agency head Marty Makary stepping down earlier this month. His time at the FDA drew criticism from several companies over the agency’s handling of drug reviews.

REPL Q4 Forecast

The biotech firm is expected to post a loss of $0.72 per share for the fourth quarter, according to Fiscal.ai data. This is slightly narrower than the loss of $0.82 per share in the previous corresponding period.

Retail sentiment remained in the ‘bullish’ territory over the past 24 hours, amid ‘extremely high’ message volumes.

One user expects the company’s Q4 loss to hurt the cash balance and expects an offering.

Another user expects the stock price to double.

REPL shares have shed around 12% so far this year.

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