**Strong Phase 3 data and recent NDA acceptance underpin the 85% market-implied odds for FDA approval of daraxonrasib this year.** Revolution Medicines’ oral RAS(ON) multi-selective inhibitor showed statistically significant gains in the pivotal RASolute 302 trial, with median overall survival of 13.2 months versus 6.7 months for chemotherapy (HR 0.40) in previously treated metastatic pancreatic ductal adenocarcinoma, alongside improved progression-free survival and a manageable safety profile. The FDA granted Breakthrough Therapy and Orphan Drug designations, awarded a National Priority Voucher in 2025, and on July 22, 2026 accepted the NDA for review—signaling a complete application under expedited pathways. Traders view these elements, combined with the expanded access program authorized in May 2026, as strong indicators that approval is likely within the priority review window before year-end, though final agency decisions retain some uncertainty until the review concludes.
สรุปจาก AI ทดลองที่อ้างอิงข้อมูลจาก Polymarket ไม่ใช่คำแนะนำในการเทรดและไม่มีผลต่อการตัดสินตลาดนี้ · อัปเดตแล้วThis 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.
ตลาดเปิดเมื่อ: 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 data and recent NDA acceptance underpin the 85% market-implied odds for FDA approval of daraxonrasib this year.** Revolution Medicines’ oral RAS(ON) multi-selective inhibitor showed statistically significant gains in the pivotal RASolute 302 trial, with median overall survival of 13.2 months versus 6.7 months for chemotherapy (HR 0.40) in previously treated metastatic pancreatic ductal adenocarcinoma, alongside improved progression-free survival and a manageable safety profile. The FDA granted Breakthrough Therapy and Orphan Drug designations, awarded a National Priority Voucher in 2025, and on July 22, 2026 accepted the NDA for review—signaling a complete application under expedited pathways. Traders view these elements, combined with the expanded access program authorized in May 2026, as strong indicators that approval is likely within the priority review window before year-end, though final agency decisions retain some uncertainty until the review concludes.
สรุปจาก AI ทดลองที่อ้างอิงข้อมูลจาก Polymarket ไม่ใช่คำแนะนำในการเทรดและไม่มีผลต่อการตัดสินตลาดนี้ · อัปเดตแล้ว



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