Shares of Replimune Group, Inc. (NASDAQ:REPL) are rising Monday after the clinical stage biotechnology company shared an important regulatory update.
- REPL is charging ahead with explosive momentum. Stay ahead of the curve here.
What To Know: Replimune said the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its biologics license application (BLA) for RP1 in combination with nivolumab. RP1 is Replimune’s lead product candidate intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response.
The BLA for RP1 in combination with nivolumab is for the treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen.
The deadline for the FDA to make a decision on Replimune’s new drug application is next April. During the past few months, Replimune has been working to address agency feedback. Additional information, data and analyses were included in the resubmission, which will be part of the BLA review.
"We are pleased the agency has accepted the resubmission of our BLA for RP1," said Sushil Patel, CEO of Replimune. "RP1 plus nivolumab offers a strong risk benefit profile where there are few options for patients with advanced melanoma, who have progressed on PD-1 based therapy. We look forward to working closely with the agency to expedite this review as much as possible for patients' benefit."
Following the FDA acceptance of the company’s BLA resubmission, Wedbush analyst Robert Driscoll upgraded Replimune from Neutral to Outperform and raised the price target from $4 to $18. Leerink Partners also upgraded the stock from Market Perform to Outperform and raised the price target from $3 to $13. The positive analyst coverage appears to be helping boost shares on Monday.
REPL Analysis: Despite Monday’s gains, Replimune’s year-to-date performance remains down more than 20%, suggesting that the stock has faced challenges throughout the year. Its current setup suggests that if the stock can maintain its momentum and break through psychological resistance at $10.00, it may pave the way for a challenge towards the 52-week high. Conversely, a pullback towards the 50-day moving average could provide a critical test of support, determining the stock’s ability to sustain its recent gains.
REPL Price Action: Replimune shares were up 116.32% at $9.73 at the time of publication on Monday, according to Benzinga Pro. The stock is trading within its 52-week range of $2.68 to $17.00, reflecting a significant surge from its previous close of $4.50.
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