Will the FDA approve intismeran autogene (V940/mRNA-4157) with pembrolizumab (KEYTRUDA) for adjuvant treatment of completely resected stage IIB-IV melanoma before Apr 1, 2027?

If the FDA approves intismeran autogene (V940/mRNA-4157) with pembrolizumab (KEYTRUDA) for adjuvant treatment of completely resected stage IIB-IV melanoma for marketing before Apr 1, 2027, then the market resolves to Yes. 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 approvals that trigger the Payout Criterion: 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 approvals: Complete Response Letters (CRLs) indicating the application cannot be approved in its current form Approvable letters that require additional actions before approval Tentative approvals pending patent or exclusivity expiration FD Resolution: this play-money market resolves to the same result as the official Kalshi market settlement, linked as this market's resolution source. Observation time: the source market's final settlement after trading closes at 2027-04-01T03:59:00Z (UTC). If the source market is voided, cancelled, or its result is unavailable or ambiguous, this market is voided and positions are refunded.

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