TUDRIQEV (vusolimogene oderparepvec-wtpg) is a Replimune Group, Inc. program in Advanced melanoma previously treated with an anti-PD-1 regimen. The FDA approved it on Aug 6, 2026. 1 FDA decision on record below. Every date links its source.
Indication under review: Advanced melanoma previously treated with an anti-PD-1 regimen. Sponsor: Replimune Group, Inc. (REPL). Review status: Class 1 resubmission (third submission) Market-cap tier at the time we tracked it: Small. We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
When is TUDRIQEV (vusolimogene oderparepvec-wtpg)'s next FDA decision or readout?
No upcoming catalyst is on our calendar for TUDRIQEV (vusolimogene oderparepvec-wtpg); 1 FDA decision is on record below.
What happened at TUDRIQEV (vusolimogene oderparepvec-wtpg)'s most recent FDA decision?
On Aug 6, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
What is TUDRIQEV (vusolimogene oderparepvec-wtpg) used for?
In our records TUDRIQEV (vusolimogene oderparepvec-wtpg) is under review or in development for Advanced melanoma previously treated with an anti-PD-1 regimen.
Who makes TUDRIQEV (vusolimogene oderparepvec-wtpg)?
Replimune Group, Inc. (REPL).
Has TUDRIQEV (vusolimogene oderparepvec-wtpg) been approved by the FDA?
Yes. The FDA approved an application for TUDRIQEV (vusolimogene oderparepvec-wtpg) on Aug 6, 2026; the decision page linked above carries the source.
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
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