Replimune Group, Inc. (NASDAQ:REPL) shares plunged Friday as investors braced for a pivotal U.S. FDA decision on its lead cancer therapy, RP1.
This move comes following a report detailing the FDA’s acceptance of the resubmission of the Biologics License Application for RP1 in combination with nivolumab, a treatment for advanced melanoma, which has been under scrutiny due to previous rejections.
The FDA’s review decision is critical as it could significantly impact the stock’s trajectory.
FDA Decision Today
The FDA is set to make a decision on the Biologics License Application for RP1 on April 10.
This follows a Complete Response Letter issued in June 2025, indicating that the IGNYTE trial did not provide sufficient evidence of effectiveness, which has raised concerns about the company’s prospects.
Internal FDA Dynamics Impact Replimune Review Process
As per a media report in August 2025, the FDA’s top cancer drug regulator stepped in during the final stages of a heated review of Replimune’s skin cancer treatment — a move that played a key role in the drug being rejected at the last minute, despite support from some within the agency.
Ongoing leadership changes, staff turnover, and internal issues at the FDA influenced the review process and the decision to deny approval.
Replimune found itself caught in the middle of the agency’s internal turmoil.
The company said existing cash, cash equivalents, and short-term investments of $269.1 million will provide cash runway late into the first quarter of calendar 2027.
Analyst Consensus & Recent Actions: The stock carries a Buy Rating with an average price target of $16.60. Recent analyst moves include:
- Piper Sandler: Overweight (Raises Target to $14.00) (February 5)
- Wedbush: Outperform (Raises Target to $19.00) (February 4)
REPL Price Action: Replimune Group shares were down 19.46% at $4.760 at the time of publication on Friday, according to Benzinga Pro data.
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