Shares of Replimune Group, Inc. (REPL) plummeted 74% on Tuesday morning, after the company announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for RP1 in combination with nivolumab for the treatment of advanced melanoma.
The stock opened at $2.71, sharply down from the previous close of $12.33. The trading volume was 34.5 million shares, compared to an average of 1.57 million.
In the CRL, the FDA stated that the IGNYTE trial, which formed the basis of the BLA, was not considered an adequate and well-controlled study to provide substantial evidence of effectiveness.
"We are surprised by this FDA decision and disappointed for advanced melanoma patients who have limited treatment options," said Dr. Sushil Patel, CEO of Replimune. "The issues highlighted in the CRL were not raised by the agency during mid- and late-cycle reviews."
The company said it plans to request a Type A meeting with the FDA, expected within 30 days, to discuss potential next steps and salvage the regulatory path for RP1.
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