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Investing.com - Cantor Fitzgerald upgraded Replimune Group (NASDAQ:REPL) from Neutral to Overweight on Wednesday following the departure of FDA’s Center for Biologics Evaluation and Research (CBER) head Dr. Vinay Prasad. The upgrade sparked a notable 12.4% gain over the past week, though the stock remains down 72% over the last six months, according to InvestingPro data.
The upgrade comes just eight days after Replimune received a Complete Response Letter (CRL) for its RP1 therapy on July 22, 2025.
Cantor Fitzgerald believes the recent CRL was likely the result of senior leadership, specifically Dr. Prasad, overruling the FDA review team’s recommendation.
The research firm views Dr. Prasad’s departure as "removing a major obstacle for the potential CRL overturn" and now sees improved odds for RP1 receiving Accelerated Approval.
Cantor’s positive outlook assumes the FDA review team maintains its supportive stance toward approving the therapy.
In other recent news, Replimune Group has faced significant developments following a Complete Response Letter (CRL) from the FDA. The letter, which indicates that an application cannot be approved in its current form, has led to multiple downgrades from analysts. BMO Capital downgraded Replimune from Outperform to Underperform, reducing its price target from $27.00 to $2.00. Barclays (LON:BARC) also downgraded the company from Overweight to Equalweight, adjusting its price target from $17.00 to $3.00. Similarly, Leerink Partners changed its rating from Outperform to Market Perform, cutting the price target to $3.00 from $21.00. Jefferies maintained a Buy rating but significantly lowered its price target from $31.00 to $6.00. The CRL was issued for Replimune’s RP1 therapy in combination with nivolumab, intended for treating anti-PD-1-failed melanoma patients. The FDA cited inadequacies in the Phase II IGNYTE trial, which was deemed not sufficient to provide substantial evidence of effectiveness.
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