The FDA’s acceptance of Revolution Medicines’ NDA for daraxonrasib (RMC-6236) in July 2026, following its October 2025 National Priority Voucher, Breakthrough Therapy, and Orphan Drug designations, forms the core driver behind the 85% market-implied probability of approval this year. This oral RAS(ON) multi-selective inhibitor targets the GTP-bound active state of mutant and wild-type RAS proteins driving ~90% of pancreatic ductal adenocarcinomas; phase 3 data showed superior overall and progression-free survival versus chemotherapy in previously treated metastatic cases, with manageable safety. Expanded access authorization in May further signals regulatory confidence. Standard review timelines after NDA acceptance, combined with the priority voucher’s accelerated pathway, support strong trader consensus on near-term approval while acknowledging residual uncertainty from final labeling or data reviews.
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...The FDA’s acceptance of Revolution Medicines’ NDA for daraxonrasib (RMC-6236) in July 2026, following its October 2025 National Priority Voucher, Breakthrough Therapy, and Orphan Drug designations, forms the core driver behind the 85% market-implied probability of approval this year. This oral RAS(ON) multi-selective inhibitor targets the GTP-bound active state of mutant and wild-type RAS proteins driving ~90% of pancreatic ductal adenocarcinomas; phase 3 data showed superior overall and progression-free survival versus chemotherapy in previously treated metastatic cases, with manageable safety. Expanded access authorization in May further signals regulatory confidence. Standard review timelines after NDA acceptance, combined with the priority voucher’s accelerated pathway, support strong trader consensus on near-term approval while acknowledging residual uncertainty from final labeling or data reviews.
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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