**Recent Phase 3 success for Moderna and Merck’s personalized mRNA neoantigen vaccine (intismeran autogene) combined with Keytruda (pembrolizumab) has shifted trader focus toward potential FDA approval timelines.** In August 2026, the companies reported that the individualized therapy—produced via tumor sequencing to target patient-specific neoantigens—met primary and key secondary endpoints in resected high-risk melanoma, cutting recurrence or death risk versus checkpoint inhibitor alone. This marks the first late-stage win for a therapeutic mRNA cancer vaccine. Regulators have received initial data, with filing planned within months and possible U.S. availability targeted for 2027 if review proceeds smoothly. Separately, the FDA granted accelerated approval in August 2026 to Replimune’s oncolytic viral therapy Tudriqev (RP1) plus nivolumab for anti-PD-1-refractory advanced melanoma after prior rejections, highlighting regulatory caution on novel immunotherapies. Key catalysts ahead include full trial data presentations, formal biologics license application submission, and any advisory committee review—factors that could accelerate or delay resolution depending on manufacturing scale-up and confirmatory evidence requirements.
Experimental AI-generated summary referencing Polymarket data. This is not trading advice and plays no role in how this market resolves. · Updated$88,249 Vol.
June 30, 2027
29%
September 30, 2027
45%
December 31, 2027
66%
$88,249 Vol.
June 30, 2027
29%
September 30, 2027
45%
December 31, 2027
66%
Intismeran autogene refers to the individualized neoantigen therapy developed by Moderna and Merck and evaluated in the Phase 3 INTerpath-001 trial (NCT05933577), also known as mRNA-4157 and V940, together with any brand, trade, or nonproprietary name later assigned to that product, as well as any renamed or modified version that the relevant company or the FDA identify as the same product or a direct continuation of the V940/mRNA-4157 program.
Differences in neoantigen composition between patients will not affect resolution. Changes to the product's formulation will not affect resolution, provided the FDA approves the product described above. Approval as part of a combination regimen will qualify. Approval for a narrower population than the one studied in INTerpath-001 will qualify. Approval for an indication other than melanoma will also qualify. Both standard and accelerated approval will qualify.
An approval is defined as:
For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA)
For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced
For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA)
For biosimilars: FDA approval of a 351(k) application
The following constitute qualifying approvals:
Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs
The following do not constitute qualifying approvals:
Approvable letters that require additional actions before approval
Tentative approvals pending patent or exclusivity expiration
FDA requests for additional information or studies
Extension of Prescription Drug User Fee Act (PDUFA) dates
Approval for compassionate use or expanded access programs only
Approval only for export or for use outside the United States
Emergency Use Authorization (EUA) without full approval
Complete Response Letters (CRLs) indicating the application cannot be approved in its current form
If the listed drug is approved before the end of the specified period, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval.
Conditional approvals may include post-marketing requirements or commitments and still qualify.
The primary resolution source for this market will be official information from the FDA; however, a consensus of credible reporting may also be used.
Market Opened: Aug 20, 2026, 6:27 AM ET
Resolver
0x65070BE91...Intismeran autogene refers to the individualized neoantigen therapy developed by Moderna and Merck and evaluated in the Phase 3 INTerpath-001 trial (NCT05933577), also known as mRNA-4157 and V940, together with any brand, trade, or nonproprietary name later assigned to that product, as well as any renamed or modified version that the relevant company or the FDA identify as the same product or a direct continuation of the V940/mRNA-4157 program.
Differences in neoantigen composition between patients will not affect resolution. Changes to the product's formulation will not affect resolution, provided the FDA approves the product described above. Approval as part of a combination regimen will qualify. Approval for a narrower population than the one studied in INTerpath-001 will qualify. Approval for an indication other than melanoma will also qualify. Both standard and accelerated approval will qualify.
An approval is defined as:
For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA)
For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced
For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA)
For biosimilars: FDA approval of a 351(k) application
The following constitute qualifying approvals:
Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs
The following do not constitute qualifying approvals:
Approvable letters that require additional actions before approval
Tentative approvals pending patent or exclusivity expiration
FDA requests for additional information or studies
Extension of Prescription Drug User Fee Act (PDUFA) dates
Approval for compassionate use or expanded access programs only
Approval only for export or for use outside the United States
Emergency Use Authorization (EUA) without full approval
Complete Response Letters (CRLs) indicating the application cannot be approved in its current form
If the listed drug is approved before the end of the specified period, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval.
Conditional approvals may include post-marketing requirements or commitments and still qualify.
The primary resolution source for this market will be official information from the FDA; however, a consensus of credible reporting may also be used.
Resolver
0x65070BE91...**Recent Phase 3 success for Moderna and Merck’s personalized mRNA neoantigen vaccine (intismeran autogene) combined with Keytruda (pembrolizumab) has shifted trader focus toward potential FDA approval timelines.** In August 2026, the companies reported that the individualized therapy—produced via tumor sequencing to target patient-specific neoantigens—met primary and key secondary endpoints in resected high-risk melanoma, cutting recurrence or death risk versus checkpoint inhibitor alone. This marks the first late-stage win for a therapeutic mRNA cancer vaccine. Regulators have received initial data, with filing planned within months and possible U.S. availability targeted for 2027 if review proceeds smoothly. Separately, the FDA granted accelerated approval in August 2026 to Replimune’s oncolytic viral therapy Tudriqev (RP1) plus nivolumab for anti-PD-1-refractory advanced melanoma after prior rejections, highlighting regulatory caution on novel immunotherapies. Key catalysts ahead include full trial data presentations, formal biologics license application submission, and any advisory committee review—factors that could accelerate or delay resolution depending on manufacturing scale-up and confirmatory evidence requirements.
Experimental AI-generated summary referencing Polymarket data. This is not trading advice and plays no role in how this market resolves. · Updated


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