**Recent positive Phase 3 interim results for the leading Moderna-Merck personalized mRNA cancer vaccine (intismeran autogene/mRNA-4157) in resected high-risk melanoma have strengthened prospects, yet the market prices a 61% chance of no FDA approval by December 31, 2027.** Announced on August 19, 2026, the large trial met its primary endpoint of recurrence-free survival and the key secondary endpoint of distant metastasis-free survival when combined with Keytruda, marking the first successful Phase 3 readout for an mRNA-based neoantigen cancer vaccine. The companies are engaging regulators promptly, plan to present full data at an upcoming medical meeting, and hold breakthrough therapy designation, which can accelerate review. Analysts and company executives have cited potential availability as early as 2027, with some projecting commercial launch by late 2027 or early 2028 depending on submission timing and FDA processing. Trader sentiment favoring “No” reflects realistic remaining hurdles in the ~16-month window: the Phase 3 is still maturing, detailed data must undergo full scrutiny, a biologics license application must be filed and validated, and the FDA’s review for a novel personalized therapy typically spans 6–12 months or longer even on priority tracks. Historical precedents for innovative oncology products show frequent timeline slippage due to manufacturing scale-up for individualized vaccines, additional safety data requests, or label negotiations. While the breakthrough nature and strong efficacy signals (sustained ~49% risk reduction in prior Phase 2 follow-up) support a plausible 2027 approval path, the probability-weighted view accounts for execution risks in a first-in-class modality. Key near-term catalysts include the detailed data presentation, formal submission timeline, and any FDA meeting outcomes that could shift odds.
Experimental AI-generated summary referencing Polymarket data. This is not trading advice and plays no role in how this market resolves. · Updated44% chance
NEW
NEW
Dec 31, 2027
44% chance
NEW
NEW
Dec 31, 2027
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants approval of intismeran autogene for any indication by December 31, 2027, 11:59 PM ET. Otherwise, this market will resolve to "No".
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.**Recent positive Phase 3 interim results for the leading Moderna-Merck personalized mRNA cancer vaccine (intismeran autogene/mRNA-4157) in resected high-risk melanoma have strengthened prospects, yet the market prices a 61% chance of no FDA approval by December 31, 2027.**
Announced on August 19, 2026, the large trial met its primary endpoint of recurrence-free survival and the key secondary endpoint of distant metastasis-free survival when combined with Keytruda, marking the first successful Phase 3 readout for an mRNA-based neoantigen cancer vaccine. The companies are engaging regulators promptly, plan to present full data at an upcoming medical meeting, and hold breakthrough therapy designation, which can accelerate review. Analysts and company executives have cited potential availability as early as 2027, with some projecting commercial launch by late 2027 or early 2028 depending on submission timing and FDA processing.
Trader sentiment favoring “No” reflects realistic remaining hurdles in the ~16-month window: the Phase 3 is still maturing, detailed data must undergo full scrutiny, a biologics license application must be filed and validated, and the FDA’s review for a novel personalized therapy typically spans 6–12 months or longer even on priority tracks. Historical precedents for innovative oncology products show frequent timeline slippage due to manufacturing scale-up for individualized vaccines, additional safety data requests, or label negotiations. While the breakthrough nature and strong efficacy signals (sustained ~49% risk reduction in prior Phase 2 follow-up) support a plausible 2027 approval path, the probability-weighted view accounts for execution risks in a first-in-class modality. Key near-term catalysts include the detailed data presentation, formal submission timeline, and any FDA meeting outcomes that could shift odds.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants approval of intismeran autogene for any indication by December 31, 2027, 11:59 PM ET. Otherwise, this market will resolve to "No".
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.
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 19, 2026, 1:49 PM ET
Volume
$1,719End Date
Dec 31, 2027Market Opened
Aug 19, 2026, 1:49 PM ETResolver
0x65070BE91...This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants approval of intismeran autogene for any indication by December 31, 2027, 11:59 PM ET. Otherwise, this market will resolve to "No".
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.**Recent positive Phase 3 interim results for the leading Moderna-Merck personalized mRNA cancer vaccine (intismeran autogene/mRNA-4157) in resected high-risk melanoma have strengthened prospects, yet the market prices a 61% chance of no FDA approval by December 31, 2027.**
Announced on August 19, 2026, the large trial met its primary endpoint of recurrence-free survival and the key secondary endpoint of distant metastasis-free survival when combined with Keytruda, marking the first successful Phase 3 readout for an mRNA-based neoantigen cancer vaccine. The companies are engaging regulators promptly, plan to present full data at an upcoming medical meeting, and hold breakthrough therapy designation, which can accelerate review. Analysts and company executives have cited potential availability as early as 2027, with some projecting commercial launch by late 2027 or early 2028 depending on submission timing and FDA processing.
Trader sentiment favoring “No” reflects realistic remaining hurdles in the ~16-month window: the Phase 3 is still maturing, detailed data must undergo full scrutiny, a biologics license application must be filed and validated, and the FDA’s review for a novel personalized therapy typically spans 6–12 months or longer even on priority tracks. Historical precedents for innovative oncology products show frequent timeline slippage due to manufacturing scale-up for individualized vaccines, additional safety data requests, or label negotiations. While the breakthrough nature and strong efficacy signals (sustained ~49% risk reduction in prior Phase 2 follow-up) support a plausible 2027 approval path, the probability-weighted view accounts for execution risks in a first-in-class modality. Key near-term catalysts include the detailed data presentation, formal submission timeline, and any FDA meeting outcomes that could shift odds.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants approval of intismeran autogene for any indication by December 31, 2027, 11:59 PM ET. Otherwise, this market will resolve to "No".
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.
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.
Volume
$1,719End Date
Dec 31, 2027Market Opened
Aug 19, 2026, 1:49 PM ETResolver
0x65070BE91...**Recent positive Phase 3 interim results for the leading Moderna-Merck personalized mRNA cancer vaccine (intismeran autogene/mRNA-4157) in resected high-risk melanoma have strengthened prospects, yet the market prices a 61% chance of no FDA approval by December 31, 2027.** Announced on August 19, 2026, the large trial met its primary endpoint of recurrence-free survival and the key secondary endpoint of distant metastasis-free survival when combined with Keytruda, marking the first successful Phase 3 readout for an mRNA-based neoantigen cancer vaccine. The companies are engaging regulators promptly, plan to present full data at an upcoming medical meeting, and hold breakthrough therapy designation, which can accelerate review. Analysts and company executives have cited potential availability as early as 2027, with some projecting commercial launch by late 2027 or early 2028 depending on submission timing and FDA processing. Trader sentiment favoring “No” reflects realistic remaining hurdles in the ~16-month window: the Phase 3 is still maturing, detailed data must undergo full scrutiny, a biologics license application must be filed and validated, and the FDA’s review for a novel personalized therapy typically spans 6–12 months or longer even on priority tracks. Historical precedents for innovative oncology products show frequent timeline slippage due to manufacturing scale-up for individualized vaccines, additional safety data requests, or label negotiations. While the breakthrough nature and strong efficacy signals (sustained ~49% risk reduction in prior Phase 2 follow-up) support a plausible 2027 approval path, the probability-weighted view accounts for execution risks in a first-in-class modality. Key near-term catalysts include the detailed data presentation, formal submission timeline, and any FDA meeting outcomes that could shift odds.
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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