Earnings summaries and quarterly performance for Replimune Group.
Executive leadership at Replimune Group.
Board of directors at Replimune Group.
CO
Christy Oliger
Detailed
Director
DW
Dieter Weinand
Detailed
Lead Independent Director
JS
Joseph Slattery
Detailed
Director
KD
Kapil Dhingra
Detailed
Director
MB
Madhavan Balachandran
Detailed
Director
MG
Michael Goller
Detailed
Director
PP
Paolo Pucci
Detailed
Director
PA
Philip Astley-Sparke
Detailed
Executive Chairman
VP
Veleka Peeples-Dyer
Detailed
Director
Research analysts who have asked questions during Replimune Group earnings calls.
Allison Bratzel
Piper Sandler Companies
1 question for REPL
Also covers: ABCL, AKBA, ALXO +5 more
AR
Anupam Rama
JPMorgan Chase & Co.
1 question for REPL
Also covers: APLS, BBIO, BOLD +16 more
ES
Evan Seigerman
BMO Capital Markets
1 question for REPL
Also covers: ABBV, AMGN, ARVN +15 more
JS
Jiale Song
Jefferies Financial Group Inc.
1 question for REPL
Also covers: ACRS, CRVS, CTMX +12 more
JC
Jonathan Chang
Leerink Partners
1 question for REPL
Also covers: ADAP, GMAB, IMCR +10 more
PL
Peter Lawson
Barclays PLC
1 question for REPL
Also covers: ADAP, ARVN, BPMC +15 more
Recent press releases and 8-K filings for REPL.
Replimune Prepares for RP1 Commercial Launch and Provides Pipeline Updates
REPL
Product Launch
New Projects/Investments
Guidance Update
- Replimune is preparing for the near-term approval and commercial launch of RP1, with a PDUFA date of April 10th for its class two resubmission.
- The company reported a cash balance of approximately $270 million, providing about a one-year runway and sufficient funds for the commercial launch.
- Clinical data from the IGNITE trial for anti-PD-1 failed melanoma demonstrated a 34% response rate, and the FDA has confirmed the trial design is acceptable for registrational purposes.
- Replimune has commercial supply for RP1 ready and is expanding its pipeline with a registrational trial (Reveal) for uveal melanoma using RP2, which has over 50 patients enrolled and expects preliminary data for 90 patients in early 2027.
Jan 14, 2026, 9:30 PM
Replimune Provides Update on RP1 Approval, Commercial Launch, and Pipeline at J.P. Morgan Healthcare Conference
REPL
Product Launch
New Projects/Investments
- Replimune is preparing for the near-term approval and commercial launch of RP1, with a PDUFA date of April 10th for its class two resubmission, and has commercial supply for RP1 ready.
- The IGNITE trial for RP1 in anti-PD-1 failed melanoma demonstrated a 34% response rate in primary resistant patients and durable responses, with the FDA confirming the trial design for registrational purposes. Replimune estimates a 10,000 addressable patient opportunity for RP1, with 80% of these patients eligible for treatment.
- The company is advancing its pipeline, with over 60 patients enrolled in the IGNITE-3 trial for RP1 and over 50 patients enrolled in the registrational Reveal trial for RP2 in uveal melanoma, with preliminary data for Reveal expected in early 2027.
- Replimune has approximately $270 million in cash, providing about a one-year runway and fully funding its commercial launch.
Jan 14, 2026, 9:30 PM
REPL Provides Update on RPx Oncolytic Immunotherapy Platform and Commercialization
REPL
Product Launch
New Projects/Investments
- REPL is preparing for the commercial launch of its RPx oncolytic immunotherapy for melanoma, with a PDUFA date of April 10, 2026, and has its commercial team and manufacturing facility "launch ready".
- The IGNYTE study demonstrated a 33.6% Overall Response Rate (ORR) in anti-PD-1 failed melanoma patients, with the confirmatory IGNYTE-3 study on track for an interim OS analysis in 2H 2027.
- The company is expanding its RPx platform, showing an ORR of 34.6% with RP1 monotherapy in locally advanced cutaneous squamous cell carcinoma (CSCC) in solid organ transplant patients (ARTACUS study).
- REPL estimates a market opportunity of approximately 10,000 addressable injectable melanoma patients and a potential to reach up to ~130,000 patients across various indications beyond skin cancers.
Jan 14, 2026, 9:30 PM
Replimune Discusses RP1 Approval Outlook, Commercial Plans, and Clinical Progress
REPL
Product Launch
New Projects/Investments
Guidance Update
- Replimune is anticipating FDA approval for RP1, with a PDUFA date of April 10th for its Class 2 resubmission, and has confirmed the IGNYTE trial design is acceptable for registrational purposes.
- The company is prepared for the commercial launch of RP1, with commercial supply available and logistics simplified for next-day delivery and room temperature stability. Initial commercial efforts will target approximately 150 accounts.
- Clinical data for RP1 includes a 34% response rate in anti-PD-1 failed melanoma from the IGNYTE trial , and promising monotherapy results showing a 34% response rate in locally advanced CSCC in solid organ transplant patients and a 100% response rate in low-risk resectable CSCC.
- Replimune is expanding its pipeline, with the REVEAL trial for RP2 in uveal melanoma having over 50 patients enrolled and preliminary data for 90 patients expected in early 2027. The company also has approximately $270 million in cash, providing about a year of runway and fully funding the commercial launch.
Jan 14, 2026, 9:30 PM
Replimune Group, Inc. Provides Update on RP1 PDUFA Date, Commercial Readiness, and Clinical Pipeline
REPL
Product Launch
New Projects/Investments
- Replimune Group, Inc. anticipates a PDUFA date of April 10, 2026, for its RP1 treatment in melanoma.
- The company is poised for commercial launch success, with over 150 accounts ready on day one and its U.S. manufacturing facility prepared with RP1 launch supply.
- As of December 31, 2025, Replimune reported unaudited cash of $269.2 million.
- Replimune has 7 ongoing clinical trials for RP1 and RP2, including the registrational Phase 2/3 REVEAL study for metastatic uveal melanoma with an interim OS analysis planned for the second half of 2027, and preliminary HCC data expected in the second half of 2026.
Jan 12, 2026, 1:00 PM
Replimune Presents RP1 Clinical Data at SITC 2025
REPL
New Projects/Investments
Product Launch
- Replimune Group presented biomarker and updated clinical data from the IGNYTE clinical trial of RP1 plus nivolumab at the 40th Annual Meeting of the Society for the Immunotherapy of Cancer (SITC 2025).
- The data demonstrated that RP1 plus nivolumab can potentially reprogram the tumor microenvironment and reverse mechanisms of resistance to immune checkpoint blockade.
- With an additional 7 months of follow-up, RP1 combined with nivolumab showed a clinically meaningful overall response rate (ORR) of 33.6% and a median duration of response of 24.8 months in melanoma patients who previously failed anti-PD-1 therapy.
- Consistent duration of response was observed across PD-L1–positive and negative tumors, as well as in both primary and secondary resistance settings.
Nov 7, 2025, 9:45 PM
Replimune Group, Inc. Reports Q2 2026 Financial Results and FDA BLA Acceptance for RP1
REPL
Earnings
Guidance Update
Product Launch
- The FDA accepted Replimune's Biologics License Application (BLA) resubmission for RP1 for advanced melanoma, setting a Prescription Drug User Fee Act (PDUFA) target action date for April 10, 2026.
- As of September 30, 2025, cash, cash equivalents, and short-term investments totaled $323.6 million, which is expected to fund operations late into the fourth quarter of 2026.
- For the fiscal second quarter ended September 30, 2025, Replimune reported a net loss of $83.1 million, with research and development expenses at $57.9 million and selling, general and administrative expenses at $26.4 million.
- Key clinical trials for RP1 (IGNYTE-3 in advanced melanoma) and RP2 (REVEAL in metastatic uveal melanoma) are actively enrolling patients.
Nov 6, 2025, 1:20 PM
Replimune Announces FDA Acceptance of BLA Resubmission for RP1
REPL
Product Launch
- Replimune Group, Inc. announced that the U.S. Food and Drug Administration (FDA) accepted the resubmission of its Biologics License Application (BLA) for RP1.
- The BLA is for RP1 in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on an anti-PD-1 containing regimen.
- The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 10, 2026, based on a Class II resubmission timeline.
- This resubmission is considered a complete response to the complete response letter received in July 2025.
Oct 20, 2025, 11:20 AM
Replimune Announces FDA Acceptance of RP1 BLA Resubmission
REPL
Product Launch
New Projects/Investments
- Replimune Group announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its Biologics License Application (BLA) for RP1.
- The BLA is for RP1 in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on an anti-PD-1 containing regimen.
- The FDA has set a PDUFA date of April 10, 2026, for the review, based on a Class II resubmission timeline.
- This resubmission is considered a complete response to the complete response letter received in July 2025, with additional information, data, and analyses included.
Oct 20, 2025, 11:00 AM
Replimune Group Highlights RP1 plus Nivolumab Acral Melanoma Data at ESMO Congress 2025
REPL
New Projects/Investments
- Replimune Group, Inc. announced new data from an ad hoc analysis of the IGNYTE phase 2 cohort of RP1 plus nivolumab for acral melanoma patients.
- Presented at the European Society for Medical Oncology (ESMO) Congress 2025, the analysis showed an objective response rate of 44% (8/18) with a median duration of response of 11.9 months in acral melanoma patients.
- Acral melanoma is a rare and aggressive type of cutaneous melanoma that typically does not respond well to available therapies, and the safety profile of RP1 plus nivolumab was favorable.
- The IGNYTE-3 randomized controlled phase 3 trial evaluating RP1 plus nivolumab in melanoma that has progressed on anti-PD1 and anti-CTLA-4 therapy is currently recruiting.
Oct 19, 2025, 12:00 PM
Quarterly earnings call transcripts for Replimune Group.
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