Replimune's (REPL) RP1, in combination with nivolumab, is likely to receive US Food and Drug Administration approval for PD-1-refractory advanced melanoma, Wedbush analysts said in a Friday note, following an FDA advisory committee's 10-3 vote in favor of the treatment.
The biologics license application has a Prescription Drug User Fee Act target action date of Aug. 2, though Wedbush said approval could be delayed.
Analysts said the FDA's decision to conduct a third review of the BLA and convene an advisory committee meeting signaled a willingness to approve RP1.
Wedbush said that the company will target an initial market of 150 clinics, followed by expansion to 350 treatment centers, within six to nine months of launch.
Analysts added that Replimune does, however, face potential financing risk, given its current cash runway is only expected to fund operations into Q1 2027.
Wedbush retained a neutral rating on the stock, but increased its price target to $12 from $9.
Shares were up more than 100% in Friday trading.
Price: $10.28, Change: $+4.87, Percent Change: +89.94%