**Positive Phase 3 results for Moderna and Merck’s personalized mRNA melanoma vaccine (intismeran autogene, also known as mRNA-4157 or V940) are the main driver behind current trader sentiment.** On August 19, 2026, the companies announced that the large INTerpath-001 trial (1,137 patients with resected high-risk stage IIB–IV cutaneous melanoma) met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival when the individualized neoantigen mRNA therapy was added to pembrolizumab (Keytruda). The combination showed clinically meaningful benefit over Keytruda alone, with no new safety signals. This marks the first positive Phase 3 readout for any personalized mRNA cancer vaccine and builds on consistent earlier Phase 2b data showing sustained risk reductions (around 49% for recurrence or death at five years). Moderna and Merck stated they will present detailed results at an upcoming medical meeting and immediately engage regulators, including the FDA, on filing plans. The program already holds breakthrough therapy designation, which supports expedited review pathways. Traders view a BLA submission (or FDA acceptance) by June 30, 2027 as highly likely given the strong data, regulatory momentum, and typical timelines from positive Phase 3 topline to filing in oncology. Key near-term catalysts include the full data presentation and any announced regulatory meetings or pre-BLA feedback. Uncertainties remain around manufacturing scale-up for a personalized therapy, exact filing timing, and potential data nuances that could affect review speed, but the recent trial success has created broad consensus around a near-term submission.
Riepilogo sperimentale generato dall'AI con riferimento ai dati di Polymarket. Questo non è un consiglio di trading e non ha alcun ruolo nella risoluzione di questo mercato. · AggiornatoVaccino contro il cancro della pelle BLA presentato da...?
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$44,260 Vol.
31 mar 2027
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88%
$44,260 Vol.
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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 March 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.
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 March 31, 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.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 melanoma vaccine (intismeran autogene, also known as mRNA-4157 or V940) are the main driver behind current trader sentiment.**
On August 19, 2026, the companies announced that the large INTerpath-001 trial (1,137 patients with resected high-risk stage IIB–IV cutaneous melanoma) met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival when the individualized neoantigen mRNA therapy was added to pembrolizumab (Keytruda). The combination showed clinically meaningful benefit over Keytruda alone, with no new safety signals.
This marks the first positive Phase 3 readout for any personalized mRNA cancer vaccine and builds on consistent earlier Phase 2b data showing sustained risk reductions (around 49% for recurrence or death at five years). Moderna and Merck stated they will present detailed results at an upcoming medical meeting and immediately engage regulators, including the FDA, on filing plans. The program already holds breakthrough therapy designation, which supports expedited review pathways.
Traders view a BLA submission (or FDA acceptance) by June 30, 2027 as highly likely given the strong data, regulatory momentum, and typical timelines from positive Phase 3 topline to filing in oncology. Key near-term catalysts include the full data presentation and any announced regulatory meetings or pre-BLA feedback. Uncertainties remain around manufacturing scale-up for a personalized therapy, exact filing timing, and potential data nuances that could affect review speed, but the recent trial success has created broad consensus around a near-term submission.
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 March 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.
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 March 31, 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 March 31, 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.
Mercato aperto: Aug 31, 2026, 11:11 AM ET
Volume
$44,260Data di fine
30 giu 2027Mercato aperto
Aug 31, 2026, 11:11 AM ETRisolutore
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 March 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.
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 March 31, 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.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 melanoma vaccine (intismeran autogene, also known as mRNA-4157 or V940) are the main driver behind current trader sentiment.**
On August 19, 2026, the companies announced that the large INTerpath-001 trial (1,137 patients with resected high-risk stage IIB–IV cutaneous melanoma) met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival when the individualized neoantigen mRNA therapy was added to pembrolizumab (Keytruda). The combination showed clinically meaningful benefit over Keytruda alone, with no new safety signals.
This marks the first positive Phase 3 readout for any personalized mRNA cancer vaccine and builds on consistent earlier Phase 2b data showing sustained risk reductions (around 49% for recurrence or death at five years). Moderna and Merck stated they will present detailed results at an upcoming medical meeting and immediately engage regulators, including the FDA, on filing plans. The program already holds breakthrough therapy designation, which supports expedited review pathways.
Traders view a BLA submission (or FDA acceptance) by June 30, 2027 as highly likely given the strong data, regulatory momentum, and typical timelines from positive Phase 3 topline to filing in oncology. Key near-term catalysts include the full data presentation and any announced regulatory meetings or pre-BLA feedback. Uncertainties remain around manufacturing scale-up for a personalized therapy, exact filing timing, and potential data nuances that could affect review speed, but the recent trial success has created broad consensus around a near-term submission.
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 March 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.
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 March 31, 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 March 31, 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
$44,260Data di fine
30 giu 2027Mercato aperto
Aug 31, 2026, 11:11 AM ETRisolutore
0x65070BE91...**Positive Phase 3 results for Moderna and Merck’s personalized mRNA melanoma vaccine (intismeran autogene, also known as mRNA-4157 or V940) are the main driver behind current trader sentiment.** On August 19, 2026, the companies announced that the large INTerpath-001 trial (1,137 patients with resected high-risk stage IIB–IV cutaneous melanoma) met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival when the individualized neoantigen mRNA therapy was added to pembrolizumab (Keytruda). The combination showed clinically meaningful benefit over Keytruda alone, with no new safety signals. This marks the first positive Phase 3 readout for any personalized mRNA cancer vaccine and builds on consistent earlier Phase 2b data showing sustained risk reductions (around 49% for recurrence or death at five years). Moderna and Merck stated they will present detailed results at an upcoming medical meeting and immediately engage regulators, including the FDA, on filing plans. The program already holds breakthrough therapy designation, which supports expedited review pathways. Traders view a BLA submission (or FDA acceptance) by June 30, 2027 as highly likely given the strong data, regulatory momentum, and typical timelines from positive Phase 3 topline to filing in oncology. Key near-term catalysts include the full data presentation and any announced regulatory meetings or pre-BLA feedback. Uncertainties remain around manufacturing scale-up for a personalized therapy, exact filing timing, and potential data nuances that could affect review speed, but the recent trial success has created broad consensus around a near-term submission.
Riepilogo sperimentale generato dall'AI con riferimento ai dati di Polymarket. Questo non è un consiglio di trading e non ha alcun ruolo nella risoluzione di questo mercato. · Aggiornato
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