Strong Phase 3 RASolute 302 trial results announced in mid-April 2026, showing daraxonrasib doubling median overall survival to 13.2 months versus 6.7 months with chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), underpin the 70% market-implied odds for FDA approval in 2026. The oral RAS(ON) multi-selective inhibitor met all primary and secondary endpoints with a manageable safety profile, prompting Revolution Medicines to plan a new drug application under the Commissioner’s National Priority Voucher program. Prior Breakthrough Therapy and Orphan Drug designations, plus the FDA’s rapid May 2026 authorization of an expanded access protocol, signal accelerated regulatory engagement for this high-unmet-need RAS-driven cancer therapy. Ongoing first-line trials and NEJM publication of supporting Phase 1/2 data further support trader confidence in timely review, though final approval timing remains subject to FDA data review.
Polymarket 데이터를 참조하는 실험적 AI 생성 요약입니다. 이것은 거래 조언이 아니며 이 마켓의 정산에 영향을 미치지 않습니다. · 업데이트예
예
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.
마켓 개설일: 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 mid-April 2026, showing daraxonrasib doubling median overall survival to 13.2 months versus 6.7 months with chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), underpin the 70% market-implied odds for FDA approval in 2026. The oral RAS(ON) multi-selective inhibitor met all primary and secondary endpoints with a manageable safety profile, prompting Revolution Medicines to plan a new drug application under the Commissioner’s National Priority Voucher program. Prior Breakthrough Therapy and Orphan Drug designations, plus the FDA’s rapid May 2026 authorization of an expanded access protocol, signal accelerated regulatory engagement for this high-unmet-need RAS-driven cancer therapy. Ongoing first-line trials and NEJM publication of supporting Phase 1/2 data further support trader confidence in timely review, though final approval timing remains subject to FDA data review.
Polymarket 데이터를 참조하는 실험적 AI 생성 요약입니다. 이것은 거래 조언이 아니며 이 마켓의 정산에 영향을 미치지 않습니다. · 업데이트
외부 링크에 주의하세요.
외부 링크에 주의하세요.
자주 묻는 질문