REPL Stock Shot Up 80% Today – What’s The Deal With FDA?

• The FDA indicated that it will treat the filing as an urgent matter and prioritize the review process.
• The FDA had twice rejected the application earlier, leading to Replimune’s CEO Sushil Patel calling the regulator’s review process inconsistent.
• The agreement follows a leadership shake-up at the FDA, with agency head Marty Makary stepping down earlier this month.

Shares of Replimune Group (REPL) surged 80% on Friday, after the biotech firm reignited investor optimism by finally securing an agreement with the U.S. Food and Drug Administration to resubmit a marketing application for its lead skin cancer therapy that had previously faced two regulatory setbacks.

REPL shares breached their 200-day moving average (200-DMA) for the first time since April 8, and are set to post their biggest single-day gains in more than seven months.

FDA To Prioritize Review Process

Replimune said it reached an agreement with the FDA on a path forward for resubmitting its Biologics License Application (BLA) for RP1 in combination with Nivolumab to treat advanced melanoma. The company said it plans to resubmit the application in the coming days.

The FDA has indicated it will treat the filing as an urgent matter and prioritize the review, citing the significant unmet need among patients with advanced melanoma.

The update comes after the FDA rejected the application twice, first in July 2025 and again in April 2026. Following the second Complete Response Letter (CRL) by the FDA, Replimune’s CEO Sushil Patel criticized the regulator’s review process as inconsistent and said the rejection would force the company to cut jobs and scale back U.S. manufacturing operations.

Replimune also claimed the agency changed review teams during the process and raised concerns that differed from earlier feedback provided to the company.

Agreement After FDA Leadership Shakeup

The agreement also follows a leadership shakeup at the FDA, with 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.

Some firms accused the regulator of being inconsistent and unpredictable in its decision-making process. The disputes added to broader industry concerns about delays and uncertainty surrounding approvals for new treatments.

REPL Traders Expect FDA Approval

Retail sentiment surrounding REPL on Stocktwits flipped to ‘bullish’ from ‘bearish’ a day earlier.  

One user said the drug’s approval looks increasingly likely, which would force a major re-rating of the stock.

Another user expects the stock to climb to $12, a near 50% increase from current levels.

The stock has declined around 17% so far this year.

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