Recent positive Phase 3 results for Moderna and Merck’s personalized mRNA vaccine intismeran autogene (mRNA-4157/V940) plus Keytruda have driven trader sentiment on FDA approval timelines for this skin cancer therapy. Announced August 19, 2026, the INTerpath-001 trial met its primary recurrence-free survival endpoint and key secondary distant metastasis-free survival goal in 1,137 resected high-risk melanoma patients, building on sustained five-year Phase 2 data showing a 49% risk reduction. The companies are already engaging regulators and hold breakthrough therapy designation, positioning the individualized neoantigen approach for potential filing within months and possible accelerated review. Full data presentation at an upcoming medical meeting, manufacturing scale-up for the bespoke mRNA platform, and standard FDA review cycles remain key variables that could influence approval by late 2026 or into 2027.
Experimental AI-generated summary referencing Polymarket data. This is not trading advice and plays no role in how this market resolves. · Updated$116,819 Vol.
Dec 31, 2027
June 30, 2027
29%
September 30, 2027
42%
December 31, 2027
66%
$116,819 Vol.
June 30, 2027
$13,047 Vol.
29%
September 30, 2027
$3,236 Vol.
42%
December 31, 2027
$100,537 Vol.
66%
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants approval of intismeran autogene for any indication by June 30, 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.This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants approval of intismeran autogene for any indication by September 30, 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.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 results for Moderna and Merck’s personalized mRNA vaccine intismeran autogene (mRNA-4157/V940) plus Keytruda have driven trader sentiment on FDA approval timelines for this skin cancer therapy. Announced August 19, 2026, the INTerpath-001 trial met its primary recurrence-free survival endpoint and key secondary distant metastasis-free survival goal in 1,137 resected high-risk melanoma patients, building on sustained five-year Phase 2 data showing a 49% risk reduction. The companies are already engaging regulators and hold breakthrough therapy designation, positioning the individualized neoantigen approach for potential filing within months and possible accelerated review. Full data presentation at an upcoming medical meeting, manufacturing scale-up for the bespoke mRNA platform, and standard FDA review cycles remain key variables that could influence approval by late 2026 or into 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 June 30, 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 20, 2026, 6:27 AM ET
Volume
$116,819End Date
Jan 1, 2028Market Opened
Aug 20, 2026, 6:27 AM 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 June 30, 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.This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants approval of intismeran autogene for any indication by September 30, 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.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 results for Moderna and Merck’s personalized mRNA vaccine intismeran autogene (mRNA-4157/V940) plus Keytruda have driven trader sentiment on FDA approval timelines for this skin cancer therapy. Announced August 19, 2026, the INTerpath-001 trial met its primary recurrence-free survival endpoint and key secondary distant metastasis-free survival goal in 1,137 resected high-risk melanoma patients, building on sustained five-year Phase 2 data showing a 49% risk reduction. The companies are already engaging regulators and hold breakthrough therapy designation, positioning the individualized neoantigen approach for potential filing within months and possible accelerated review. Full data presentation at an upcoming medical meeting, manufacturing scale-up for the bespoke mRNA platform, and standard FDA review cycles remain key variables that could influence approval by late 2026 or into 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 June 30, 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
$116,819End Date
Jan 1, 2028Market Opened
Aug 20, 2026, 6:27 AM ETResolver
0x65070BE91...Recent positive Phase 3 results for Moderna and Merck’s personalized mRNA vaccine intismeran autogene (mRNA-4157/V940) plus Keytruda have driven trader sentiment on FDA approval timelines for this skin cancer therapy. Announced August 19, 2026, the INTerpath-001 trial met its primary recurrence-free survival endpoint and key secondary distant metastasis-free survival goal in 1,137 resected high-risk melanoma patients, building on sustained five-year Phase 2 data showing a 49% risk reduction. The companies are already engaging regulators and hold breakthrough therapy designation, positioning the individualized neoantigen approach for potential filing within months and possible accelerated review. Full data presentation at an upcoming medical meeting, manufacturing scale-up for the bespoke mRNA platform, and standard FDA review cycles remain key variables that could influence approval by late 2026 or into 2027.
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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Frequently Asked Questions