**Positive Phase 3 results from Moderna and Merck’s INTerpath-001 trial, announced August 19, 2026, represent the key driver behind the 87.5% implied probability for a BLA submission by June 30, 2027.** The personalized mRNA neoantigen therapy (intismeran autogene / mRNA-4157 / V940) combined with Keytruda met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival in resected high-risk melanoma, delivering statistically significant and clinically meaningful improvements. Companies have stated they will present full data at an upcoming medical meeting and immediately engage regulators on filing plans, building on the therapy’s existing breakthrough therapy designation. With the trial now positioned for a potential submission in late 2026 or early 2027, traders view the timeline to BLA as comfortably achievable well before the mid-2027 cutoff, barring unexpected regulatory requests for additional data. Upcoming catalysts include the full dataset release and initial FDA interactions that could further de-risk the filing window.
Experimental AI-generated summary referencing Polymarket data. This is not trading advice and plays no role in how this market resolves. · Updated88% chance
$38,832 Vol.
$38,832 Vol.
Jun 30, 2027
88% chance
$38,832 Vol.
$38,832 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 from Moderna and Merck’s INTerpath-001 trial, announced August 19, 2026, represent the key driver behind the 87.5% implied probability for a BLA submission by June 30, 2027.** The personalized mRNA neoantigen therapy (intismeran autogene / mRNA-4157 / V940) combined with Keytruda met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival in resected high-risk melanoma, delivering statistically significant and clinically meaningful improvements. Companies have stated they will present full data at an upcoming medical meeting and immediately engage regulators on filing plans, building on the therapy’s existing breakthrough therapy designation. With the trial now positioned for a potential submission in late 2026 or early 2027, traders view the timeline to BLA as comfortably achievable well before the mid-2027 cutoff, barring unexpected regulatory requests for additional data. Upcoming catalysts include the full dataset release and initial FDA interactions that could further de-risk the filing window.
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
$38,832End 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 from Moderna and Merck’s INTerpath-001 trial, announced August 19, 2026, represent the key driver behind the 87.5% implied probability for a BLA submission by June 30, 2027.** The personalized mRNA neoantigen therapy (intismeran autogene / mRNA-4157 / V940) combined with Keytruda met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival in resected high-risk melanoma, delivering statistically significant and clinically meaningful improvements. Companies have stated they will present full data at an upcoming medical meeting and immediately engage regulators on filing plans, building on the therapy’s existing breakthrough therapy designation. With the trial now positioned for a potential submission in late 2026 or early 2027, traders view the timeline to BLA as comfortably achievable well before the mid-2027 cutoff, barring unexpected regulatory requests for additional data. Upcoming catalysts include the full dataset release and initial FDA interactions that could further de-risk the filing window.
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
$38,832End Date
Jun 30, 2027Market Opened
Aug 19, 2026, 2:46 PM ETResolver
0x65070BE91...**Positive Phase 3 results from Moderna and Merck’s INTerpath-001 trial, announced August 19, 2026, represent the key driver behind the 87.5% implied probability for a BLA submission by June 30, 2027.** The personalized mRNA neoantigen therapy (intismeran autogene / mRNA-4157 / V940) combined with Keytruda met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival in resected high-risk melanoma, delivering statistically significant and clinically meaningful improvements. Companies have stated they will present full data at an upcoming medical meeting and immediately engage regulators on filing plans, building on the therapy’s existing breakthrough therapy designation. With the trial now positioned for a potential submission in late 2026 or early 2027, traders view the timeline to BLA as comfortably achievable well before the mid-2027 cutoff, barring unexpected regulatory requests for additional data. Upcoming catalysts include the full dataset release and initial FDA interactions that could further de-risk the filing window.
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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