Positive Phase 3 RASolute 302 trial results announced in April 2026, later published in the New England Journal of Medicine, provide the main catalyst for the 87.5% market-implied odds of FDA approval for daraxonrasib this year. In previously treated metastatic pancreatic ductal adenocarcinoma, the oral RAS inhibitor delivered a median overall survival of 13.2 months versus 6.7 months with chemotherapy (hazard ratio 0.40), alongside doubled progression-free survival and a manageable safety profile with fewer discontinuations. These data address a critical unmet need in RAS G12-mutated disease, where historical outcomes remain poor. FDA expanded-access authorization and the drug’s targeted mechanism further support accelerated review timelines, though final approval hinges on full data review and agency decisions amid typical oncology regulatory uncertainty.
Eksperimental na AI-generated summary na nire-reference ang Polymarket data. Hindi ito trading advice at wala itong papel sa kung paano nire-resolve ang market na ito. · Na-updateFDA approves Daraxonrasib this year?
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.
Binuksan ang Market: 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...Positive Phase 3 RASolute 302 trial results announced in April 2026, later published in the New England Journal of Medicine, provide the main catalyst for the 87.5% market-implied odds of FDA approval for daraxonrasib this year. In previously treated metastatic pancreatic ductal adenocarcinoma, the oral RAS inhibitor delivered a median overall survival of 13.2 months versus 6.7 months with chemotherapy (hazard ratio 0.40), alongside doubled progression-free survival and a manageable safety profile with fewer discontinuations. These data address a critical unmet need in RAS G12-mutated disease, where historical outcomes remain poor. FDA expanded-access authorization and the drug’s targeted mechanism further support accelerated review timelines, though final approval hinges on full data review and agency decisions amid typical oncology regulatory uncertainty.
Eksperimental na AI-generated summary na nire-reference ang Polymarket data. Hindi ito trading advice at wala itong papel sa kung paano nire-resolve ang market na ito. · Na-update



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