Recent positive Phase 3 results from the RASolute 302 trial, showing significant progression-free and overall survival benefits in previously treated metastatic pancreatic ductal adenocarcinoma with KRAS G12 mutations, have strengthened trader confidence in 2026 FDA approval. The agency’s rapid “safe to proceed” letter for expanded access in late April, combined with prior Breakthrough Therapy, Orphan Drug, and National Priority Voucher designations, signals an accelerated review pathway for the RAS(ON) multi-selective inhibitor. Revolution Medicines plans an NDA submission under the priority voucher program, which historically shortens timelines for high-priority therapies. While final approval hinges on full data review and manufacturing standards, these developments explain the current 70.5% implied probability for approval before year-end.
基于Polymarket数据的AI实验性摘要。这不是交易建议,也不影响该市场的结算方式。 · 更新于是
是
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.
市场开放时间: 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 3 results from the RASolute 302 trial, showing significant progression-free and overall survival benefits in previously treated metastatic pancreatic ductal adenocarcinoma with KRAS G12 mutations, have strengthened trader confidence in 2026 FDA approval. The agency’s rapid “safe to proceed” letter for expanded access in late April, combined with prior Breakthrough Therapy, Orphan Drug, and National Priority Voucher designations, signals an accelerated review pathway for the RAS(ON) multi-selective inhibitor. Revolution Medicines plans an NDA submission under the priority voucher program, which historically shortens timelines for high-priority therapies. While final approval hinges on full data review and manufacturing standards, these developments explain the current 70.5% implied probability for approval before year-end.
基于Polymarket数据的AI实验性摘要。这不是交易建议,也不影响该市场的结算方式。 · 更新于
警惕外部链接哦。
警惕外部链接哦。
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