**Strong Phase 3 efficacy data and an expedited FDA review pathway underpin the 63% market-implied probability of approval by year-end.** Revolution Medicines’ RASolute 302 trial, with topline results released in April 2026 and full publication in the New England Journal of Medicine on May 31, demonstrated that daraxonrasib (RMC-6236), an oral RAS(ON) multi-selective inhibitor, nearly doubled median overall survival to 13.2 months versus 6.7 months with chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), including patients with KRAS G12 mutations; progression-free survival also improved significantly with a manageable safety profile. The FDA had already granted Breakthrough Therapy and Orphan Drug designations, awarded a Commissioner’s National Priority Voucher in October 2025, and authorized expanded access in May 2026. On July 23, 2026, the agency accepted the New Drug Application under the priority voucher program, triggering a faster review. These elements—unprecedented survival gains in a high-unmet-need setting plus regulatory acceleration—support trader consensus on likely approval before December 31, 2026, while residual uncertainty around review timelines and any last-minute data requests keeps the probability below 90%.
Polymarketデータを参照したAI生成の実験的な要約。これは取引アドバイスではなく、このマーケットの解決方法には一切関係ありません。 · 更新日はい
はい
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.
マーケット開始日: 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...**Strong Phase 3 efficacy data and an expedited FDA review pathway underpin the 63% market-implied probability of approval by year-end.** Revolution Medicines’ RASolute 302 trial, with topline results released in April 2026 and full publication in the New England Journal of Medicine on May 31, demonstrated that daraxonrasib (RMC-6236), an oral RAS(ON) multi-selective inhibitor, nearly doubled median overall survival to 13.2 months versus 6.7 months with chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), including patients with KRAS G12 mutations; progression-free survival also improved significantly with a manageable safety profile. The FDA had already granted Breakthrough Therapy and Orphan Drug designations, awarded a Commissioner’s National Priority Voucher in October 2025, and authorized expanded access in May 2026. On July 23, 2026, the agency accepted the New Drug Application under the priority voucher program, triggering a faster review. These elements—unprecedented survival gains in a high-unmet-need setting plus regulatory acceleration—support trader consensus on likely approval before December 31, 2026, while residual uncertainty around review timelines and any last-minute data requests keeps the probability below 90%.
Polymarketデータを参照したAI生成の実験的な要約。これは取引アドバイスではなく、このマーケットの解決方法には一切関係ありません。 · 更新日



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