Recent positive Phase 2 data showing unprecedented overall survival in previously treated metastatic pancreatic ductal adenocarcinoma with KRAS G12 mutations, announced in April 2026, combined with the FDA’s national priority voucher from October 2025, form the main driver behind the 70.5% market-implied probability of approval this year. The voucher enables expedited review, while the May 2026 “safe to proceed” letter for expanded access underscores regulatory engagement and urgency for this RAS(ON) inhibitor. A Phase 3 trial readout expected around mid-2026 will supply pivotal evidence, though NDA submission timing and full data review still carry inherent uncertainty typical of accelerated oncology pathways.
Polymarket 데이터를 참조하는 실험적 AI 생성 요약입니다. 이것은 거래 조언이 아니며 이 마켓의 정산에 영향을 미치지 않습니다. · 업데이트예
예
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants a full or conditional approval for a drug product whose active ingredient is Revolution Medicines’ daraxonrasib (including any brand name or identifier) for any use between market creation and December 31, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No."
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 Amendments 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 within this market’s timeframe, 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 will be official information from the FDA; however, a consensus of credible reporting will also be used.
마켓 개설일: May 13, 2026, 5:28 PM ET
Resolver
0x65070BE91...This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants a full or conditional approval for a drug product whose active ingredient is Revolution Medicines’ daraxonrasib (including any brand name or identifier) for any use between market creation and December 31, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No."
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 Amendments 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 within this market’s timeframe, 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 will be official information from the FDA; however, a consensus of credible reporting will also be used.
Resolver
0x65070BE91...Recent positive Phase 2 data showing unprecedented overall survival in previously treated metastatic pancreatic ductal adenocarcinoma with KRAS G12 mutations, announced in April 2026, combined with the FDA’s national priority voucher from October 2025, form the main driver behind the 70.5% market-implied probability of approval this year. The voucher enables expedited review, while the May 2026 “safe to proceed” letter for expanded access underscores regulatory engagement and urgency for this RAS(ON) inhibitor. A Phase 3 trial readout expected around mid-2026 will supply pivotal evidence, though NDA submission timing and full data review still carry inherent uncertainty typical of accelerated oncology pathways.
Polymarket 데이터를 참조하는 실험적 AI 생성 요약입니다. 이것은 거래 조언이 아니며 이 마켓의 정산에 영향을 미치지 않습니다. · 업데이트
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