Recent positive results from the phase 3 RASolute 302 trial, which demonstrated significant overall survival gains in previously treated metastatic pancreatic ductal adenocarcinoma, have strengthened trader confidence in a 2026 FDA approval. The agency’s May 1 issuance of a “safe to proceed” letter for an expanded access program, combined with the drug’s earlier breakthrough therapy designation, orphan drug status, and Commissioner’s National Priority Voucher granted in October 2025, signals an expedited regulatory pathway. These developments follow publication of supporting phase 1/2 data in the New England Journal of Medicine and the sponsor’s stated intent to file a new drug application imminently under the priority voucher framework. While full approval remains contingent on successful NDA review and data verification, the combination of robust trial outcomes and accelerated FDA mechanisms underpins the current 70.5% market-implied probability for yes.
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 results from the phase 3 RASolute 302 trial, which demonstrated significant overall survival gains in previously treated metastatic pancreatic ductal adenocarcinoma, have strengthened trader confidence in a 2026 FDA approval. The agency’s May 1 issuance of a “safe to proceed” letter for an expanded access program, combined with the drug’s earlier breakthrough therapy designation, orphan drug status, and Commissioner’s National Priority Voucher granted in October 2025, signals an expedited regulatory pathway. These developments follow publication of supporting phase 1/2 data in the New England Journal of Medicine and the sponsor’s stated intent to file a new drug application imminently under the priority voucher framework. While full approval remains contingent on successful NDA review and data verification, the combination of robust trial outcomes and accelerated FDA mechanisms underpins the current 70.5% market-implied probability for yes.
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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警惕外部連結哦。
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