Replimune secures FDA approval for Tudriqev, eyes $1.3 bn peak sales in advanced melanoma

Replimune announced FDA approval of its therapy Tudriqev for patients with advanced melanoma who have progressed after PD-1 treatment.

Analysts at BMO Capital Markets project the drug could generate about $1.3 billion in peak annual revenue by 2035, citing the broad label and limited competition.

The approval moved the company from a regulatory struggle to a commercial focus, with the CEO thanking internal and external supporters.

Replimune’s stock jumped more than 8% to close around $12.86 after the news, rebounding from a low of $1.70 earlier in the year.