Replimune Group, Inc. (REPL)
Replimune Stock Rallies on BLA Filing for Melanoma Combo Drug
REPL stock soars after submitting a BLA to the FDA seeking accelerated approval for its lead candidate, RP1, in combination with Opdivo for advanced melanoma.
Replimune: Strong Data In A Highly Differentiated Space
Replimune's RP1, an oncolytic immuno-gene therapy, shows promise with a 31.4% ORR in phase 2 trials for post PD-1 melanoma and non-melanoma skin cancers. RP2, adding an anti-CTLA-4 component to RP1, demonstrated a 29.4% ORR in phase 1 trials, with durable responses in difficult-to-treat tumors. Despite competitive challenges and a failed CSCC trial, Replimune's cash runway supports its accelerated approval and phase 3 trials, making it an attractive investment.
Replimune (REPL) Gains on Positive Data From Melanoma Study
Replimune's (REPL) lead pipeline candidate RP1, in combination with Opdivo, leads to an overall response rate of 33.6% in patients with anti-PD1 failed melanoma. Shares gain.
