Replimune Group: The Prospects For FDA Approval After Rejection
Replimune Group's RP1 oncolytic virus therapy faced an FDA rejection, raising concerns about the platform's viability in refractory melanoma. The company's pipeline is centered on RP1, making the recent setback particularly significant for its near-term prospects. There is a very real chance that the FDA will ultimately allow for accelerated approval.
Replimune Group, Inc. (REPL) Q4 2025 Earnings Call Transcript
Replimune Group, Inc. (NASDAQ:REPL ) Q4 2025 Results Conference Call May 22, 2025 8:00 AM ET Company Participants Arleen Goldenberg - Senior Communications Leader Sushil Patel - Chief Executive Officer Chris Sarchi - Chief Commercial Officer Emily Hill - Chief Financial Officer Conference Call Participants Anupam Rama - J.P. Morgan Roger Song - Jefferies Jonathan Chang - Leerink Allison Bratzel - Piper Sandler Peter Lawson - Barclays Operator Good morning and welcome to the Replimune Fiscal Year Fourth Quarter 2025 Financial Results and Corporate Update Conference Call.
Replimune: Scope Goes Beyond That Of RP1 Oncolytic Targeting For Melanoma
Replimune Group, Inc.'s BLA of RP1 + OPDIVO in advanced melanoma received an FDA Priority Review, with a PDUFA date set for July 22, 2025. RP2, adding an anti-CTLA-4 component, is being tested in metastatic uveal melanoma and 2nd-line metastatic hepatocellular carcinoma patients. Financially, Replimune has $536.5 million in cash, but REPL will likely need additional funding within the next 12 months.
Replimune: A Misunderstood Contender In Oncolytics
Replimune Group's solid cash position and strategic focus on niche oncology markets position it for potential success, despite market volatility and past trial setbacks. The company's RP1 and RP2 platforms target unmet needs in melanoma and other cancers, with promising data and regulatory momentum supporting their potential. The FDA's Priority Review and Breakthrough Therapy designations for RP1 underscore its potential to reshape second-line melanoma treatment and expedite market entry.
REPL Stock Rises on FDA's Priority Review for Melanoma Drug BLA
The FDA accepts and grants priority review to Replimune's BLA for RP1 in combination with Opdivo for advanced melanoma. A decision is due on July 22, 2025.
Replimune: RPL1 BLA Submission Under AA Pathway Makes It A Must Watch
Replimune has submitted its BLA of RP1 + Opdivo for the treatment of advanced melanoma patients previously treated with an anti-PD1 containing regimen. The phase 3 confirmatory IGNYTE-3 study is underway to prove yet again that RP1 + Opdivo is able to help these patients with advanced melanoma and to keep the drug marketed. The global melanoma therapeutics market size is projected to reach $17.93 billion by 2034.
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.
