Replimune Shares Plummet to All-Time Low as FDA Rejection Muddies Path Forward

By Elias Schisgall

Shares of Replimune Group continued their free fall and touched an all-time low after the company's application for a melanoma treatment was rejected by the Food and Drug Administration for a second time, which analysts said raises considerable uncertainty for the company's path forward.

Shares were down 61% to $1.86 in Monday morning trading, after hitting their all-time low of $1.50 earlier in the session. The stock has now fallen about 75% this year.

The FDA on Friday said the biotechnology company failed to provide data showing that RP1, also known as vusolimogene oderparepvec, can effectively treat unresectable advanced cutaneous melanoma. Replimune fired back at the FDA later Friday, accusing the agency of inconsistencies and poor communication.

Some analysts wrote that the FDA's decision was a disappointment, given what they saw as sufficient evidence for an approval from the company's Ignyte study. Nonetheless, they cut the stock's ratings, citing uncertainty about the company's prospects for future approvals, including an ongoing Phase 3 study of RP1.

"We see no path forward for RP1 with Ignyte, and significant risk with regards to the ongoing Ph 3 study," Wedbush analysts wrote in a note, downgrading the stock to neutral and cutting their price target to $2 from $19.

JPMorgan analysts wrote that they expect the stock to trade down to low single digits per share, adding that a sentiment overhang could lead to relative underperformance. They downgraded the stock to underweight and withdrew their price target.

Replimune will need to align with the FDA about the Phase 3 study, they wrote. "Further, we would anticipate the company will likely need to restructure around IGNYTE-3, given the late stage nature of the program, and de-prioritizing earlier stage pipeline efforts (removing upside from early stage pipeline wins)," the analysts wrote.

Replimune Chief Executive Officer Sushil Patel said Friday that the company will be forced to cut jobs and scale back its U.S. manufacturing as a result of the FDA's decision. He did not address the path forward for the Phase 3 trial.

Write to Elias Schisgall at elias.schisgall@wsj.com

(END) Dow Jones Newswires

April 13, 2026 11:44 ET (15:44 GMT)