**Positive Phase 3 results for Moderna and Merck’s personalized mRNA vaccine intismeran autogene (mRNA-4157/V940) in adjuvant melanoma, announced August 19, 2026, form the main driver behind the 87.5% market-implied odds of a BLA submission by June 30, 2027.** The INTerpath-001 trial (1,137 patients with resected high-risk stage IIB–IV melanoma) met its primary endpoint of recurrence-free survival and key secondary endpoint of distant metastasis-free survival when the individualized mRNA vaccine was combined with Keytruda (pembrolizumab). These data build on earlier Phase 2 signals showing durable benefit and support the companies’ plans to present full results at an upcoming medical meeting while beginning regulatory discussions. The candidate already holds Breakthrough Therapy Designation, which can accelerate FDA review timelines. Executives have indicated that a filing could occur in late 2026 or early 2027 if data review proceeds smoothly, leaving substantial runway before the June 2027 deadline. Moderna’s established mRNA manufacturing platform, proven during COVID-19 vaccine development, further reduces perceived timeline risk for personalized neoantigen production. Traders see limited downside because the companies have publicly committed to pursuing approval submissions, and historical precedents show the FDA can act on strong oncology data within months once a complete package is filed. Key upcoming catalysts include the detailed data presentation, formal pre-BLA or BLA meetings with the FDA, and any manufacturing or additional data requests. While personalized vaccine logistics introduce some uncertainty, the recent clinical success and explicit regulatory engagement plans underpin the strong trader consensus reflected in the current odds.
Experimental AI-generated summary referencing Polymarket data. This is not trading advice and plays no role in how this market resolves. · Updated88% chance
$39,865 Vol.
$39,865 Vol.
Jun 30, 2027
88% chance
$39,865 Vol.
$39,865 Vol.
Jun 30, 2027
This market will resolve to "Yes" if it is officially announced that a Biologics License Application (BLA) for intismeran autogene has been submitted to the U.S. Food and Drug Administration (FDA), or that the FDA has accepted such an application for review, 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.
A qualifying application must seek FDA licensure of intismeran autogene through a Biologics License Application (BLA). An original BLA or a resubmission of such a BLA following FDA action will qualify. The application may cover any indication.
A qualifying announcement must come from the relevant company submitting the BLA, the FDA, or authorized representatives thereof.
The submission must already have occurred at the time of the statement. A statement of intent, plan, guidance, or expected timing will not qualify.
If the FDA grants approval of intismeran autogene on or before June 30, 2027, 11:59 PM ET, this market will resolve to "Yes", whether or not a submission was separately disclosed.
The primary resolution source for this market will be official communications from the company submitting the BLA, the FDA, or authorized representatives thereof; however, a consensus of credible reporting may also be used.**Positive Phase 3 results for Moderna and Merck’s personalized mRNA vaccine intismeran autogene (mRNA-4157/V940) in adjuvant melanoma, announced August 19, 2026, form the main driver behind the 87.5% market-implied odds of a BLA submission by June 30, 2027.**
The INTerpath-001 trial (1,137 patients with resected high-risk stage IIB–IV melanoma) met its primary endpoint of recurrence-free survival and key secondary endpoint of distant metastasis-free survival when the individualized mRNA vaccine was combined with Keytruda (pembrolizumab). These data build on earlier Phase 2 signals showing durable benefit and support the companies’ plans to present full results at an upcoming medical meeting while beginning regulatory discussions. The candidate already holds Breakthrough Therapy Designation, which can accelerate FDA review timelines.
Executives have indicated that a filing could occur in late 2026 or early 2027 if data review proceeds smoothly, leaving substantial runway before the June 2027 deadline. Moderna’s established mRNA manufacturing platform, proven during COVID-19 vaccine development, further reduces perceived timeline risk for personalized neoantigen production. Traders see limited downside because the companies have publicly committed to pursuing approval submissions, and historical precedents show the FDA can act on strong oncology data within months once a complete package is filed.
Key upcoming catalysts include the detailed data presentation, formal pre-BLA or BLA meetings with the FDA, and any manufacturing or additional data requests. While personalized vaccine logistics introduce some uncertainty, the recent clinical success and explicit regulatory engagement plans underpin the strong trader consensus reflected in the current odds.
This market will resolve to "Yes" if it is officially announced that a Biologics License Application (BLA) for intismeran autogene has been submitted to the U.S. Food and Drug Administration (FDA), or that the FDA has accepted such an application for review, 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.
A qualifying application must seek FDA licensure of intismeran autogene through a Biologics License Application (BLA). An original BLA or a resubmission of such a BLA following FDA action will qualify. The application may cover any indication.
A qualifying announcement must come from the relevant company submitting the BLA, the FDA, or authorized representatives thereof.
The submission must already have occurred at the time of the statement. A statement of intent, plan, guidance, or expected timing will not qualify.
If the FDA grants approval of intismeran autogene on or before June 30, 2027, 11:59 PM ET, this market will resolve to "Yes", whether or not a submission was separately disclosed.
The primary resolution source for this market will be official communications from the company submitting the BLA, the FDA, or authorized representatives thereof; 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.
A qualifying application must seek FDA licensure of intismeran autogene through a Biologics License Application (BLA). An original BLA or a resubmission of such a BLA following FDA action will qualify. The application may cover any indication.
A qualifying announcement must come from the relevant company submitting the BLA, the FDA, or authorized representatives thereof.
The submission must already have occurred at the time of the statement. A statement of intent, plan, guidance, or expected timing will not qualify.
If the FDA grants approval of intismeran autogene on or before June 30, 2027, 11:59 PM ET, this market will resolve to "Yes", whether or not a submission was separately disclosed.
The primary resolution source for this market will be official communications from the company submitting the BLA, the FDA, or authorized representatives thereof; however, a consensus of credible reporting may also be used.
Market Opened: Aug 19, 2026, 2:46 PM ET
Volume
$39,865End Date
Jun 30, 2027Market Opened
Aug 19, 2026, 2:46 PM ETResolver
0x65070BE91...This market will resolve to "Yes" if it is officially announced that a Biologics License Application (BLA) for intismeran autogene has been submitted to the U.S. Food and Drug Administration (FDA), or that the FDA has accepted such an application for review, 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.
A qualifying application must seek FDA licensure of intismeran autogene through a Biologics License Application (BLA). An original BLA or a resubmission of such a BLA following FDA action will qualify. The application may cover any indication.
A qualifying announcement must come from the relevant company submitting the BLA, the FDA, or authorized representatives thereof.
The submission must already have occurred at the time of the statement. A statement of intent, plan, guidance, or expected timing will not qualify.
If the FDA grants approval of intismeran autogene on or before June 30, 2027, 11:59 PM ET, this market will resolve to "Yes", whether or not a submission was separately disclosed.
The primary resolution source for this market will be official communications from the company submitting the BLA, the FDA, or authorized representatives thereof; however, a consensus of credible reporting may also be used.**Positive Phase 3 results for Moderna and Merck’s personalized mRNA vaccine intismeran autogene (mRNA-4157/V940) in adjuvant melanoma, announced August 19, 2026, form the main driver behind the 87.5% market-implied odds of a BLA submission by June 30, 2027.**
The INTerpath-001 trial (1,137 patients with resected high-risk stage IIB–IV melanoma) met its primary endpoint of recurrence-free survival and key secondary endpoint of distant metastasis-free survival when the individualized mRNA vaccine was combined with Keytruda (pembrolizumab). These data build on earlier Phase 2 signals showing durable benefit and support the companies’ plans to present full results at an upcoming medical meeting while beginning regulatory discussions. The candidate already holds Breakthrough Therapy Designation, which can accelerate FDA review timelines.
Executives have indicated that a filing could occur in late 2026 or early 2027 if data review proceeds smoothly, leaving substantial runway before the June 2027 deadline. Moderna’s established mRNA manufacturing platform, proven during COVID-19 vaccine development, further reduces perceived timeline risk for personalized neoantigen production. Traders see limited downside because the companies have publicly committed to pursuing approval submissions, and historical precedents show the FDA can act on strong oncology data within months once a complete package is filed.
Key upcoming catalysts include the detailed data presentation, formal pre-BLA or BLA meetings with the FDA, and any manufacturing or additional data requests. While personalized vaccine logistics introduce some uncertainty, the recent clinical success and explicit regulatory engagement plans underpin the strong trader consensus reflected in the current odds.
This market will resolve to "Yes" if it is officially announced that a Biologics License Application (BLA) for intismeran autogene has been submitted to the U.S. Food and Drug Administration (FDA), or that the FDA has accepted such an application for review, 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.
A qualifying application must seek FDA licensure of intismeran autogene through a Biologics License Application (BLA). An original BLA or a resubmission of such a BLA following FDA action will qualify. The application may cover any indication.
A qualifying announcement must come from the relevant company submitting the BLA, the FDA, or authorized representatives thereof.
The submission must already have occurred at the time of the statement. A statement of intent, plan, guidance, or expected timing will not qualify.
If the FDA grants approval of intismeran autogene on or before June 30, 2027, 11:59 PM ET, this market will resolve to "Yes", whether or not a submission was separately disclosed.
The primary resolution source for this market will be official communications from the company submitting the BLA, the FDA, or authorized representatives thereof; 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.
A qualifying application must seek FDA licensure of intismeran autogene through a Biologics License Application (BLA). An original BLA or a resubmission of such a BLA following FDA action will qualify. The application may cover any indication.
A qualifying announcement must come from the relevant company submitting the BLA, the FDA, or authorized representatives thereof.
The submission must already have occurred at the time of the statement. A statement of intent, plan, guidance, or expected timing will not qualify.
If the FDA grants approval of intismeran autogene on or before June 30, 2027, 11:59 PM ET, this market will resolve to "Yes", whether or not a submission was separately disclosed.
The primary resolution source for this market will be official communications from the company submitting the BLA, the FDA, or authorized representatives thereof; however, a consensus of credible reporting may also be used.
Volume
$39,865End Date
Jun 30, 2027Market Opened
Aug 19, 2026, 2:46 PM ETResolver
0x65070BE91...**Positive Phase 3 results for Moderna and Merck’s personalized mRNA vaccine intismeran autogene (mRNA-4157/V940) in adjuvant melanoma, announced August 19, 2026, form the main driver behind the 87.5% market-implied odds of a BLA submission by June 30, 2027.** The INTerpath-001 trial (1,137 patients with resected high-risk stage IIB–IV melanoma) met its primary endpoint of recurrence-free survival and key secondary endpoint of distant metastasis-free survival when the individualized mRNA vaccine was combined with Keytruda (pembrolizumab). These data build on earlier Phase 2 signals showing durable benefit and support the companies’ plans to present full results at an upcoming medical meeting while beginning regulatory discussions. The candidate already holds Breakthrough Therapy Designation, which can accelerate FDA review timelines. Executives have indicated that a filing could occur in late 2026 or early 2027 if data review proceeds smoothly, leaving substantial runway before the June 2027 deadline. Moderna’s established mRNA manufacturing platform, proven during COVID-19 vaccine development, further reduces perceived timeline risk for personalized neoantigen production. Traders see limited downside because the companies have publicly committed to pursuing approval submissions, and historical precedents show the FDA can act on strong oncology data within months once a complete package is filed. Key upcoming catalysts include the detailed data presentation, formal pre-BLA or BLA meetings with the FDA, and any manufacturing or additional data requests. While personalized vaccine logistics introduce some uncertainty, the recent clinical success and explicit regulatory engagement plans underpin the strong trader consensus reflected in the current 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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