Recent positive topline results from the Phase 3 RASolute 302 trial, announced April 13, 2026, represent the primary driver behind the 70.5% market-implied probability of FDA approval for daraxonrasib this year. The oral RAS(ON) multi-selective inhibitor achieved a statistically significant doubling of median overall survival to 13.2 months versus 6.7 months with standard chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma, with a hazard ratio of 0.40. This efficacy signal, paired with prior Breakthrough Therapy and Orphan Drug designations plus selection for the FDA’s Commissioner’s National Priority Voucher program, supports expectations for accelerated review once the new drug application is filed. The FDA’s May 1 “safe to proceed” letter authorizing an expanded access protocol further signals regulatory momentum, though final approval depends on timely submission and completion of the expedited process amid inherent uncertainties in review timelines.
基於Polymarket數據的AI實驗性摘要。這不是交易建議,也不影響該市場的結算方式。 · 更新於是
是
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.
市場開放時間: 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...Recent positive topline results from the Phase 3 RASolute 302 trial, announced April 13, 2026, represent the primary driver behind the 70.5% market-implied probability of FDA approval for daraxonrasib this year. The oral RAS(ON) multi-selective inhibitor achieved a statistically significant doubling of median overall survival to 13.2 months versus 6.7 months with standard chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma, with a hazard ratio of 0.40. This efficacy signal, paired with prior Breakthrough Therapy and Orphan Drug designations plus selection for the FDA’s Commissioner’s National Priority Voucher program, supports expectations for accelerated review once the new drug application is filed. The FDA’s May 1 “safe to proceed” letter authorizing an expanded access protocol further signals regulatory momentum, though final approval depends on timely submission and completion of the expedited process amid inherent uncertainties in review timelines.
基於Polymarket數據的AI實驗性摘要。這不是交易建議,也不影響該市場的結算方式。 · 更新於
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