REPL
Replimune Group, Inc.9.61
-0.34-3.42%
Dec 16, 4:00:00 PM EST
Earnings Call Transcripts
This Quarter (Q4 '25)
No earnings call transcript available yet
Last Quarter (Q3 '25)
No earnings call transcript available
Key Stats
Market Cap
753.84MP/E (TTM)
-Basic EPS (TTM)
-3.47Dividend Yield
0%Recent Filings
8-K
FDA accepts RP1 BLA resubmission
Replimune's BLA resubmission for RP1 in advanced melanoma gained FDA acceptance on October 20, 2025, targeting approval by April 10, 2026, after addressing a July complete response letter. The company reported a Q2 net loss of $83.1 million, up from $53.1 million last year, driven by higher R&D costs for IGNYTE-3 and RP2 trials, while cash reserves stand at $323.6 million to fund operations into late 2026. RP1 showed strong 44% ORR in acral melanoma. Cash burn accelerates commercialization prep.
10-Q
Q2 FY2026 results
Replimune's Q2 FY2026 results showed operating losses widening to $84.3M from $58.9M y/y, driven by ramped-up spending on the IGNYTE-3 confirmatory trial for RP1 and higher personnel costs, while net loss hit $83.1M versus $53.1M last year—largely due to $26.4M in SG&A for pre-launch prep. Cash burn accelerated with $158.2M used in operations for the half-year, leaving $323.6M in cash and equivalents at quarter-end, bolstered by $47.2M in long-term debt under the Hercules facility maturing 2027. The FDA accepted RP1's BLA resubmission in October, targeting a PDUFA date of April 2026, but regulatory hurdles persist. Free cash flow isn't disclosed in the 10-Q. Litigation risk looms from ongoing securities class actions tied to the prior CRL.
8-K
FDA accepts RP1 BLA resubmission
Replimune announced the FDA's acceptance of its BLA resubmission for RP1 combined with nivolumab to treat advanced melanoma in patients progressing on anti-PD-1 therapy. The PDUFA target action date is April 10, 2026, following a Class II timeline after addressing a July 2025 complete response letter. This step advances a therapy targeting unmet needs in melanoma. Yet risks persist in the review process.
8-K
FDA meeting on RP1 BLA
Replimune completed a Type A meeting with the FDA on September 16, 2025, to address the complete response letter for its BLA of RP1 combined with nivolumab in advanced melanoma. The company is now evaluating FDA feedback to chart next steps, though a path under accelerated approval remains undetermined. Patient and physician input underscores RP1's compelling risk-benefit profile from the IGNYTE trial. Yet risks persist in resolving CRL issues to FDA satisfaction.
8-K
FDA Type A meeting scheduled
Replimune Group scheduled a Type A FDA meeting on September 2, 2025, to address the complete response letter for its BLA seeking accelerated approval of RP1 combined with nivolumab in advanced melanoma. The company submitted a briefing book tackling CRL issues like patient criteria and trial design, while emphasizing urgent patient needs amid limited options. Without accelerated approval, the RP1 program in melanoma—including the phase 3 trial—won't continue. At the annual meeting, directors were elected and auditors ratified, but the incentive plan amendment failed.
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