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Shares of Replimune Group, Inc. (REPL) plunged 60% in pre-market trading on Monday, and are set to hit a record low after the U.S. Food and Drug Administration (FDA) rejected its melanoma treatment for a second time, triggering a wave of bearish brokerage reactions.
On Friday, the FDA declined to approve Replimune’s melanoma therapy, RP1, stating that the submitted data did not provide strong enough evidence of effectiveness. The regulator had already raised similar concerns in July 2025, citing that the company’s trial was not sufficiently robust to support approval.
The FDA said the updated filing failed to change its original stance, leaving the company with the option to either withdraw or resubmit the application within the next year.
Following the rejection, Replimune expressed disappointment, saying the drug showed meaningful benefits and a good safety profile, but regulatory hurdles are now putting its future at risk. The company warned it may scale back operations and cut jobs as RP1’s development becomes uncertain.
Jefferies downgraded Replimune to ‘Hold’ from ‘Buy’ and slashed its price target to $2, down significantly from its earlier estimate of $13, according to The Fly. The brokerage said it sees a “tough road ahead” for Replimune after the FDA’s rejection of RP-1. Jefferies added that the company’s path forward remains “uncertain”.
JPMorgan downgraded the stock to ‘Underweight’ from ‘Neutral’ and did not add a price target. Analyst Anupam Rama called the update “disappointing,” adding that he believed the overall RP1 data supported FDA approval. The brokerage warned that Replimune’s stock could fall into the low single digits due to the uncertainty around RP1’s future.
On Friday, BMO Capital said that the company’s path will likely be long and financially challenging.
Retail sentiment for REPL on Stocktwits remained ‘extremely bullish’ over the past 24 hours, amid ‘extremely high’ message volumes. A week back, sentiment was ‘extremely bullish’ on the platform. The stock generated significant buzz, with message volumes increasing by more than 2,000% over a seven-day period, according to Stocktwits data.
One user expects further selloff.
Year-to-date, the stock has declined more than 50%.
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