**Positive Phase 3 results from the INTerpath-001 trial of intismeran autogene (mRNA-4157/V940), Moderna's personalized mRNA neoantigen vaccine combined with Merck's Keytruda (pembrolizumab), announced August 19, 2026, represent the primary driver behind the 87.5% market-implied probability of a BLA submission by June 30, 2027.** The trial met its primary endpoint of recurrence-free survival and the key secondary endpoint of distant metastasis-free survival in patients with resected high-risk stage IIB–IV melanoma, building directly on earlier Phase 2 signals that earned Breakthrough Therapy Designation. Moderna and Merck have stated they will present full data at an upcoming medical meeting and begin regulatory engagement, with leadership noting a potential path to approval as early as 2027. Traders view the strong efficacy data, the companies' established mRNA platform experience from COVID-19 vaccines, and the expedited regulatory pathway as substantially reducing timeline risk for a filing in late 2026 or early 2027. While manufacturing complexities for individualized vaccines and possible FDA data requests introduce modest uncertainty, the proximity of the deadline (roughly 10 months from late August 2026) and clear intent to submit support the elevated consensus odds. No other skin cancer vaccine candidates appear positioned for comparable near-term progress.
Ringkasan eksperimental yang dihasilkan AI dengan referensi data Polymarket. Ini bukan saran trading dan tidak berperan dalam bagaimana pasar ini diselesaikan. · Diperbarui$40,502 Vol.
$40,502 Vol.
$40,502 Vol.
$40,502 Vol.
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.
Pasar Dibuka: Aug 19, 2026, 2:46 PM ET
Resolver
0x65070BE91...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.
Resolver
0x65070BE91...**Positive Phase 3 results from the INTerpath-001 trial of intismeran autogene (mRNA-4157/V940), Moderna's personalized mRNA neoantigen vaccine combined with Merck's Keytruda (pembrolizumab), announced August 19, 2026, represent the primary driver behind the 87.5% market-implied probability of a BLA submission by June 30, 2027.** The trial met its primary endpoint of recurrence-free survival and the key secondary endpoint of distant metastasis-free survival in patients with resected high-risk stage IIB–IV melanoma, building directly on earlier Phase 2 signals that earned Breakthrough Therapy Designation. Moderna and Merck have stated they will present full data at an upcoming medical meeting and begin regulatory engagement, with leadership noting a potential path to approval as early as 2027. Traders view the strong efficacy data, the companies' established mRNA platform experience from COVID-19 vaccines, and the expedited regulatory pathway as substantially reducing timeline risk for a filing in late 2026 or early 2027. While manufacturing complexities for individualized vaccines and possible FDA data requests introduce modest uncertainty, the proximity of the deadline (roughly 10 months from late August 2026) and clear intent to submit support the elevated consensus odds. No other skin cancer vaccine candidates appear positioned for comparable near-term progress.
Ringkasan eksperimental yang dihasilkan AI dengan referensi data Polymarket. Ini bukan saran trading dan tidak berperan dalam bagaimana pasar ini diselesaikan. · Diperbarui


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