**Strong Phase 3 efficacy data and expedited regulatory pathways underpin the 77.5% market-implied probability of FDA approval for daraxonrasib (RMC-6236) in 2026.** In April 2026, Revolution Medicines reported that its oral RAS(ON) multi-selective inhibitor met all primary and key secondary endpoints in the RASolute 302 trial for previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). Daraxonrasib achieved median overall survival of 13.2 months versus 6.7 months with chemotherapy (hazard ratio 0.40) in patients with RAS G12 mutations, alongside doubled progression-free survival and a manageable safety profile. The FDA granted Breakthrough Therapy and Orphan Drug designations, awarded a Commissioner’s National Priority Voucher in October 2025 for accelerated review, cleared an expanded access protocol in May 2026, and accepted the New Drug Application in July 2026. These factors—combined with the drug’s targeted mechanism against KRAS-driven tumors and the remaining months in 2026—support trader consensus on likely approval before year-end, though final labeling decisions and manufacturing reviews introduce some uncertainty.
Eksperymentalne podsumowanie AI odwołujące się do danych Polymarket. To nie jest porada handlowa i nie ma wpływu na rozstrzyganie tego rynku. · ZaktualizowanoFDA 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.
Rynek otwarty: 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 expedited regulatory pathways underpin the 77.5% market-implied probability of FDA approval for daraxonrasib (RMC-6236) in 2026.** In April 2026, Revolution Medicines reported that its oral RAS(ON) multi-selective inhibitor met all primary and key secondary endpoints in the RASolute 302 trial for previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). Daraxonrasib achieved median overall survival of 13.2 months versus 6.7 months with chemotherapy (hazard ratio 0.40) in patients with RAS G12 mutations, alongside doubled progression-free survival and a manageable safety profile. The FDA granted Breakthrough Therapy and Orphan Drug designations, awarded a Commissioner’s National Priority Voucher in October 2025 for accelerated review, cleared an expanded access protocol in May 2026, and accepted the New Drug Application in July 2026. These factors—combined with the drug’s targeted mechanism against KRAS-driven tumors and the remaining months in 2026—support trader consensus on likely approval before year-end, though final labeling decisions and manufacturing reviews introduce some uncertainty.
Eksperymentalne podsumowanie AI odwołujące się do danych Polymarket. To nie jest porada handlowa i nie ma wpływu na rozstrzyganie tego rynku. · Zaktualizowano



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