Asset profile

vusolimogene oderparepvec · Replimune (REPL)

Indication: advanced melanoma in patients who have progressed on prior anti-PD-1 therapy
Also known as: RP1

Company

Replimune Group Inc is a clinical-stage biotechnology company. It uses a proprietary RPx platform to design and develop product candidates that are intended to maximally activate the immune system against solid tumors. The RPx platform is based on a proprietar…

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On the calendar

Aug 2026

Aug 2, 2026

45 days ago

REPLReplimune

Replimune: FDA accepts RP1 BLA resubmission for advanced melanoma

Rescheduled — was Apr 10, 2026

FDA decision (PDUFA)Complete response letterSEC 8-K

Jun 2028

~ Jun 2028

REPLReplimune

vusolimogene oderparepvec: Phase 2 trial NCT03767348 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

Jul 2029

~ Jul 2029

REPLReplimune

vusolimogene oderparepvec: Phase 1/Phase 2 trial NCT04349436 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

Oct 2029

Oct 31, 2029

in 1141 days

REPLReplimune

vusolimogene oderparepvec: Phase 2 trial NCT06898970 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

Sep 2030

Sep 30, 2030

in 1475 days

REPLReplimune

vusolimogene oderparepvec: Phase 3 trial NCT06264180 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

Timeline

Newest first.

Decision-grade

Jul 31, 2026

12:02 AM

REPLReplimune

Replimune: FDA AdComm votes 10-3 IGNYTE efficacy results evaluable and clinically meaningful

Advisory committee voteSEC 8-K Open record2 updates

Material

Jun 29, 2026

12:11 PM

REPLReplimune

Replimune: FDA accepts RP1 BLA resubmission, sets Aug 2 2026 PDUFA

Application acceptedSEC 8-K Open record

Decision-grade

Jun 26, 2026

12:14 PM

REPLReplimune

Replimune: FDA accepts RP1 BLA resubmission for advanced melanoma

PDUFA date extendedSEC 8-K Open record

Decision-grade

May 29, 2026

01:56 PM

REPLReplimune

Replimune plans RP1 BLA resubmission after FDA alignment

Application submittedSEC 8-K Open record

Decision-grade

Apr 10, 2026

09:59 PM

REPLReplimune

Replimune receives FDA CRL for RP1 BLA in advanced melanoma

Complete response letterSEC 8-K Open record3 updates

Decision-grade

Feb 3, 2026

01:05 PM

REPLReplimune

Replimune: FDA sets April 10, 2026 PDUFA for RP1 BLA in melanoma

PDUFA date setSEC 8-K Open record

Material

Nov 6, 2025

01:20 PM

REPLReplimune

Replimune: FDA accepts RP1 BLA resubmission, sets April 10, 2026 PDUFA

Application acceptedSEC 8-K Open record

Material

Oct 20, 2025

11:20 AM

REPLReplimune

Replimune: FDA accepts RP1 BLA resubmission; PDUFA April 10, 2026

Application acceptedSEC 8-K Open record

Readiness checklist

Public facts only. We never publish an approval probability.

Updated Sep 15, 2026

Primary endpoint metUnknown

Overall survival significant or trendingUnknown

US / Western patient shareFavourable

116 of 215 sites in the United States

Advisory committee scheduledMixed

Replimune: FDA AdComm votes 10-3 IGNYTE efficacy results evaluable and clinically meaningful

PDUFA date extendedConcern

Replimune: FDA accepts RP1 BLA resubmission for advanced melanoma

Manufacturing inspection recordUnknown

No public inspection record

Company language signals (label discussions)Unknown

Same-class precedentConcern

Replimune receives FDA CRL for RP1 BLA in advanced melanoma

Related companies

Each relationship is backed by the filing that stated it.

REPLReplimuneOwner

SEC 8-K Jun 29, 2026
Company press release Jul 30, 2026
Company press release Apr 10, 2026

Verify every date against the linked primary source. Informational only. Not investment advice. SimianX is not affiliated with the FDA or the SEC.

Registered trials

Registry ID	Phase	Status	Primary completion	Enrollment	Sites
NCT04050436	Phase 2	Active, not recruiting	Sep 1, 2025	231	14 of 56 sites in the United States
NCT06264180	Phase 3	Recruiting	Sep 30, 2030	400	50 of 81 sites in the United States
NCT03767348	Phase 2	Active, not recruiting	Jun 1, 2028	340	26 of 51 sites in the United States
NCT04349436	Phase 1/2	Active, not recruiting	Jul 1, 2029	69	24 of 24 sites in the United States
NCT06067061	Phase 1/2	Terminated	May 7, 2025	2	0 of 1 sites in the United States
NCT05858229	Phase 1/2	Active, not recruiting	Dec 1, 2025	12	1 of 1 sites in the United States
NCT06898970	Phase 2	Recruiting	Oct 31, 2029	18	1 of 1 sites in the United States

More from Replimune

Other drugs and candidates from the same company tracked in this sector.

RP1anti-PD-1 failed melanoma vusolimogene oderparepvec-wtpgadvanced refractory melanoma