**The FDA's July 22, 2026 acceptance of Revolution Medicines' NDA for daraxonrasib—an oral RAS(ON) multi-selective inhibitor—combined with robust Phase 3 data from the RASolute 302 trial, underpins the market's 85% implied probability of approval this year.** Positive topline results released in April showed statistically significant gains versus chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), with median overall survival of 13.2 months versus 6.6–6.7 months (hazard ratio 0.40) and progression-free survival roughly doubled in both the RAS G12-mutated and overall populations. The drug demonstrated a manageable safety profile, lower discontinuation rates, and quality-of-life benefits. Regulatory tailwinds further support rapid review: Breakthrough Therapy and Orphan Drug designations, plus a National Priority Voucher awarded in late 2025, typically shorten timelines for serious unmet-need indications like pretreated PDAC. Expanded access was also authorized in May 2026, signaling agency confidence. With the NDA under active review and no major safety signals reported, traders view full approval by year-end as the most likely outcome, though final labeling and any manufacturing or data queries could still influence the exact PDUFA timing.
Experimental AI-generated summary referencing Polymarket data. This is not trading advice and plays no role in how this market resolves. · UpdatedThis 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.
Market Opened: 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 July 22, 2026 acceptance of Revolution Medicines' NDA for daraxonrasib—an oral RAS(ON) multi-selective inhibitor—combined with robust Phase 3 data from the RASolute 302 trial, underpins the market's 85% implied probability of approval this year.** Positive topline results released in April showed statistically significant gains versus chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), with median overall survival of 13.2 months versus 6.6–6.7 months (hazard ratio 0.40) and progression-free survival roughly doubled in both the RAS G12-mutated and overall populations. The drug demonstrated a manageable safety profile, lower discontinuation rates, and quality-of-life benefits. Regulatory tailwinds further support rapid review: Breakthrough Therapy and Orphan Drug designations, plus a National Priority Voucher awarded in late 2025, typically shorten timelines for serious unmet-need indications like pretreated PDAC. Expanded access was also authorized in May 2026, signaling agency confidence. With the NDA under active review and no major safety signals reported, traders view full approval by year-end as the most likely outcome, though final labeling and any manufacturing or data queries could still influence the exact PDUFA timing.
Experimental AI-generated summary referencing Polymarket data. This is not trading advice and plays no role in how this market resolves. · Updated



Beware of external links.
Beware of external links.
Frequently Asked Questions