Pravidla

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.