Replimune Tudriqev (RP1) Approved: FDA Clears Oncolytic Virus for Melanoma After Two CRLs

APPROVED August 6, 2026: The FDA granted accelerated approval to Replimune’s Tudriqev (vusolimogene oderparepvec-wtpg, formerly RP1) in combination with Bristol Myers Squibb’s Opdivo (nivolumab) for adults with unresectable advanced cutaneous melanoma who progressed on an anti-PD-1 regimen. The approval arrived on the company’s third BLA submission after two prior Complete Response Letters (July 2025, April 2026) and a 10-3 favorable AdComm vote on July 30. IGNYTE showed a 24.2% ORR with median DoR of 14.1 months. REPL closed at $12.86 on August 6. See our full approval coverage. The article below preserves the pre-approval timeline and analysis.

Note August 7, 2026: As of market close on Friday August 7, REPL last traded at approximately $12.70. The August 6 approval was the FDA’s ninth Q3 PDUFA approval (tenth overall outcome). Continued approval is contingent on the confirmatory Phase 3 IGNYTE-3 trial (NCT06264180), now a post-marketing requirement. The approval is a major win for the oncolytic virus field and validates Replimune’s platform after two prior CRLs.

Replimune Group (REPL) received FDA accelerated approval on August 6, 2026 for Tudriqev (RP1, vusolimogene oderparepvec-wtpg) plus nivolumab in advanced melanoma after anti-PD-1 progression. Below is the original article tracking the pre-approval timeline and analysis.

Update July 28, 2026: The FDA scheduled a CTGTAC advisory committee meeting for July 30, 2026, and released briefing documents calling the IGNYTE study “not interpretable.” REPL fell 32% intraday to $5.78 and closed at $5.35 on July 28 (Polygon), down 48.9% from the $10.46 reference price in this article. See our full coverage of the FDA briefing documents release.

Price update July 29, 2026 (Polygon): REPL closed at $5.35 on July 28, down from $8.63 on July 25 (the prior trading day). The crash followed FDA briefing documents that called the IGNYTE study “not interpretable.” The July 30 AdComm vote is the next catalyst — a negative vote makes a third CRL likely.

Update July 30, 2026: The CTGTAC advisory committee voted 10-3 that RP1 plus nivolumab has a favorable benefit-risk profile. REPL surged 39% in after-hours trading. See our full AdComm vote coverage. The August 2 PDUFA date is the FDA’s final decision deadline.

Update July 31, 2026: The August 2 PDUFA date falls on a Sunday. The FDA may act Friday July 31 or Monday August 3. REPL closed at $11.20 on July 31 (Polygon), surging 107% from the $5.41 July 29 close (halted during the July 30 AdComm) after the 10-3 favorable vote. The stock opened at $11.38 and traded as high as $12.50 intraday. Cantor Fitzgerald upgraded the stock to Overweight. Reuters reported that analysts view approval as “almost certain” following the favorable AdComm vote. The FDA is not bound by the committee’s recommendation, but the 10-3 vote significantly shifts the odds. The confirmatory Phase 3 IGNYTE-3 trial (NCT06264180) remains ongoing and would serve as the basis for any post-marketing confirmatory requirement.

Update August 2, 2026: The August 2 PDUFA date (Sunday) has passed. As of Sunday August 2, no FDA approval announcement has been made. The FDA does not typically announce decisions on weekends. The most likely timeline is a decision on Monday August 3, 2026. Markets are closed Sunday. REPL remains at $11.20 (July 31 Polygon close, +107% from the $5.41 July 29 halted close). Analysts view approval as “almost certain” after the 10-3 favorable AdComm vote, but the FDA has twice issued CRLs (July 2025 and April 2026) over IGNYTE trial design concerns. The next content refresh run on Monday will check for the FDA decision.

Update August 3, 2026: As of Monday August 3 (pre-market, 2:47 AM ET), no FDA approval announcement has been made for RP1. The FDA has not yet begun business hours. The PDUFA date (August 2, Sunday) has passed. Monday August 3 is the first business day after the PDUFA date. REPL last closed at $11.20 on July 31 (Polygon) and traded as high as $12.97 on August 2 (Sunday session, per Yahoo Finance). The stock will be closely watched at the Monday open. Analysts view approval as “almost certain” after the 10-3 favorable AdComm vote, but two prior CRLs remain a risk. If the FDA approves, this article and the AdComm vote coverage will need major updates.

Update August 6, 2026: As of Thursday August 6 (10:00 AM ET), the FDA has still not announced a decision on RP1. This is now 4 business days past the August 2 (Sunday) PDUFA date (Monday Aug 3, Tuesday Aug 4, Wednesday Aug 5, Thursday Aug 6). REPL traded in the $11.50-$12.50 range on August 5 (Yahoo Finance), continuing to hold the post-AdComm gains. The market continues to price in approval after the 10-3 favorable AdComm vote. The lack of a CRL press release from Replimune after 4 business days is increasingly notable — after two prior CRLs, the company would be obligated to disclose a third rejection. The FDA may announce at any time today during business hours.

Update August 4, 2026 (post-market): As of Tuesday August 4 market close (4:00 PM ET), the FDA has still not announced a decision on RP1. REPL traded $12.71-$13.86 on August 4 (Yahoo Finance), up 6.7%-16.4% from the August 3 close of $11.91. The stock closed near $11.84 (Google Finance). This is now 2 business days past the August 2 (Sunday) PDUFA date (Monday Aug 3 and Tuesday Aug 4). The continued gap higher — despite no FDA announcement — suggests the market is pricing in approval after the 10-3 favorable AdComm vote. The lack of a press release from Replimune is notable: after two prior CRLs, the company would be required to disclose a third rejection. The absence of such disclosure may itself be a bullish signal, though the FDA can extend review without public communication. The next content refresh run will check for a decision. If approved, a major rewrite of this article and related pieces will be needed.

The stock closed at $10.46 on July 23 with volume of 3.8 million shares, giving the company a market cap near $0.9 billion. This is a binary catalyst: approval could double or triple the stock. A third rejection would be devastating for a clinical-stage company with no revenue.

What RP1 is and why it has been rejected twice

RP1 is an oncolytic virus immunotherapy built on a proprietary strain of herpes simplex virus 1, engineered with a fusogenic protein and GM-CSF to maximize tumor killing and activate a systemic anti-tumor immune response. It is designed to be combined with checkpoint inhibitors like Bristol Myers Squibb’s Opdivo (nivolumab).

The FDA issued the first CRL in July 2025, citing inadequate evidence of effectiveness. A senior member of the original review team later stated publicly that clinical reviewers believed Replimune had provided adequate evidence of RP1’s contribution of effect, but FDA leadership disagreed. A second CRL followed in April 2026.

The June 2026 resubmission was classified as a complete Class 1 response, the most expedited review type. Replimune said the FDA has signaled a more collaborative posture following recent leadership changes at the agency.

The data behind the application

The BLA seeks accelerated approval based on the Phase 2 IGNYTE trial, which evaluated RP1 plus nivolumab in patients with confirmed progression on anti-PD-1 therapy. Key results:

• Objective response rate: 34%
• Median duration of response: 24.8 months
• RP1 holds Breakthrough Therapy and Priority Review designations

The contribution of effect question is central: the FDA’s past concern was whether RP1 adds meaningful benefit beyond nivolumab alone. The 34% response rate in a post-anti-PD-1 population, where nivolumab monotherapy has limited activity, is Replimune’s core argument.

What happened: FDA approval on August 6, 2026

The FDA granted accelerated approval to Tudriqev (RP1) on August 6, 2026 — 4 business days after the August 2 (Sunday) PDUFA date. The approval arrived on Replimune’s third BLA submission after two prior CRLs (July 2025, April 2026) and a 10-3 favorable AdComm vote on July 30. The approved indication is for adults with unresectable advanced cutaneous melanoma who have progressed on an anti-PD-1 regimen, in combination with nivolumab. Continued approval is contingent on verification of clinical benefit in the confirmatory Phase 3 IGNYTE-3 trial, which is now a post-marketing requirement.

The approval is landmark: RP1 (Tudriqev) is the first oncolytic virus immunotherapy approved for melanoma, and the first approval of its kind from the FDA’s CBER division. For full details on the accelerated approval, the IGNYTE data package, and the market implications, see our Tudriqev approval coverage.

For context on how the FDA evaluates oncology drugs after rejection, see our GSK Jideytro approval coverage.

Source: Replimune IR press release | Dermatology Times