The FDA’s acceptance of Revolution Medicines’ NDA for daraxonrasib (RMC-6236), an oral RAS(ON) multi-selective inhibitor, on July 22, 2026, under the Commissioner’s National Priority Voucher program is the main driver behind the 80% market-implied probability of approval this year. Positive topline Phase 3 RASolute 302 data released in April showed median overall survival of 13.2 months versus 6.7 months with chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma, with a hazard ratio of 0.40. Prior Breakthrough Therapy and Orphan Drug designations, plus the May expanded-access authorization, further signal regulatory confidence. Review timelines under the voucher program typically span 1–2 months, positioning a decision well before year-end barring unexpected safety findings. Trader consensus reflects the strength of registrational evidence and expedited pathway.
Polymarket ডেটা রেফারেন্স করে পরীক্ষামূলক AI-জেনারেটেড সারাংশ। এটি ট্রেডিং পরামর্শ নয় এবং এই মার্কেট কীভাবে রেজলভ হয় তাতে কোনো ভূমিকা রাখে না। · আপডেটেডThis 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.
মার্কেট ওপেন হয়েছে: 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...The FDA’s acceptance of Revolution Medicines’ NDA for daraxonrasib (RMC-6236), an oral RAS(ON) multi-selective inhibitor, on July 22, 2026, under the Commissioner’s National Priority Voucher program is the main driver behind the 80% market-implied probability of approval this year. Positive topline Phase 3 RASolute 302 data released in April showed median overall survival of 13.2 months versus 6.7 months with chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma, with a hazard ratio of 0.40. Prior Breakthrough Therapy and Orphan Drug designations, plus the May expanded-access authorization, further signal regulatory confidence. Review timelines under the voucher program typically span 1–2 months, positioning a decision well before year-end barring unexpected safety findings. Trader consensus reflects the strength of registrational evidence and expedited pathway.
Polymarket ডেটা রেফারেন্স করে পরীক্ষামূলক AI-জেনারেটেড সারাংশ। এটি ট্রেডিং পরামর্শ নয় এবং এই মার্কেট কীভাবে রেজলভ হয় তাতে কোনো ভূমিকা রাখে না। · আপডেটেড



বাহ্যিক লিংক থেকে সাবধান।
বাহ্যিক লিংক থেকে সাবধান।
সচরাচর জিজ্ঞাসা