Replimune Group (REPL) Nosedives 39% as FDA Approval for Melanoma Treatment ‘Uncertain’

We recently published 10 Stocks Losing Big Amid Market Boom. Replimune Group, Inc. (NASDAQ:REPL) is one of the worst performers on Thursday.

Replimune extended losses to a second consecutive day on Thursday, slashing 39.40 percent to close at $3.46 apiece after failing to clear regulatory challenges for its treatment candidate for melanoma.

In a statement, Replimune Group, Inc. (NASDAQ:REPL) said it met with the US Food and Drug Administration on Tuesday to discuss the agency’s complete response letter for its biologics license application for RP1, in combination with nivolumab, for the treatment of advanced melanoma.

Replimune Group (REPL) Nosedives 39% as FDA Approval for Melanoma Treatment 'Uncertain'

Mila Supinskaya Glashchenko/Shutterstock.com

However, the FDA provided a response, which Replimune Group, Inc. (NASDAQ:REPL) cannot figure out whether the drug can move forward under the FDA’s accelerated approval.

“The feedback from the melanoma community, including patients and physicians, clearly highlights the unmet need in advanced melanoma and the compelling risk-benefit profile of RP1 observed in the IGNYTE trial,” said Replimune Group, Inc. (NASDAQ:REPL) CEO Sushil Patel.

“We remain committed to working with the FDA to determine an expeditious path forward for RP1,” he added.

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Disclosure: None. This article is originally published at Insider Monkey.