REPL Stock Rallies In Anticipation Of FDA Decision On Skin Cancer Drug

• The FDA issued a complete response letter regarding the application for RP1 in combination with Nivolumab for the treatment of advanced melanoma in late July.
• Following months of engagement between the company and the FDA, the company subsequently resubmitted its application in October with additional information, data and analyses.

Shares of Replimune Group Inc (REPL) closed 11% higher on Thursday as the deadline for the U.S. Food and Drug Administration’s decision on its skin cancer therapy RP1 draws close.

The FDA is slated to decide on the company’s application for RP1 in the treatment of advanced melanoma by April 10. RP1 is Replimune’s lead product candidate.

RP1’s Past Issues

The FDA issued a complete response letter regarding the application for RP1 in combination with Nivolumab for the treatment of advanced melanoma in late July.

The agency said in the letter that it is unable to approve the application in its present form and indicated that the trial conducted by the company for the drug is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.

Following months of engagement between the company and the FDA, the company subsequently resubmitted its application in October with additional information, data and analyses.

How Did Retail Traders React?

On Stocktwits, retail sentiment around REPL stayed within the ‘bullish’ territory over the past 24 hours, while message volume rose from ‘high’ to ‘extremely high’ levels.

A Stocktwits user said that shareholders are setting up to be disappointed like the last time when RP1 was denied approval.

Yet another expressed doubts about the FDA approving the drug, opining that a fresh trial would be needed for the same.

According to data from Koyfin, five of the seven analysts covering REPL stock rate it ‘Buy’ or higher while two rate it a ‘Hold’. The 12-month average price target on the stock is $12.86, representing a potential upside of about 53%.  

REPL stock has fallen 2% over the past 12 months. 

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