Strong Phase 3 RASolute 302 trial results announced in April 2026—showing median overall survival of 13.2 months versus 6.7 months with chemotherapy (HR 0.40)—drive the 70.5% market-implied odds for FDA approval of daraxonrasib this year. The oral RAS(ON) multi-selective inhibitor demonstrated statistically significant gains in progression-free survival and objective response rate in pretreated metastatic pancreatic ductal adenocarcinoma, particularly among KRAS G12-mutated cases. These data prompted the FDA’s May 2026 expanded access protocol authorization, a national priority voucher from October 2025, and Breakthrough Therapy designation, accelerating the company’s planned new drug application. While regulatory review timelines introduce some uncertainty, the unprecedented survival benefit and expedited designations support trader consensus favoring approval before year-end.
Tóm tắt AI thử nghiệm tham chiếu dữ liệu Polymarket. Đây không phải tư vấn giao dịch và không ảnh hưởng đến cách thị trường này được giải quyết. · Cập nhậtThis 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.
Thị trường mở: 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 RASolute 302 trial results announced in April 2026—showing median overall survival of 13.2 months versus 6.7 months with chemotherapy (HR 0.40)—drive the 70.5% market-implied odds for FDA approval of daraxonrasib this year. The oral RAS(ON) multi-selective inhibitor demonstrated statistically significant gains in progression-free survival and objective response rate in pretreated metastatic pancreatic ductal adenocarcinoma, particularly among KRAS G12-mutated cases. These data prompted the FDA’s May 2026 expanded access protocol authorization, a national priority voucher from October 2025, and Breakthrough Therapy designation, accelerating the company’s planned new drug application. While regulatory review timelines introduce some uncertainty, the unprecedented survival benefit and expedited designations support trader consensus favoring approval before year-end.
Tóm tắt AI thử nghiệm tham chiếu dữ liệu Polymarket. Đây không phải tư vấn giao dịch và không ảnh hưởng đến cách thị trường này được giải quyết. · Cập nhật
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