**Daraxonrasib (RMC-6236), an oral RAS(ON) multi-selective inhibitor developed by Revolution Medicines, targets RAS-addicted cancers, particularly KRAS G12-mutated metastatic pancreatic ductal adenocarcinoma (PDAC).** The current 65% market-implied probability that the FDA will approve it in 2026 is driven primarily by the positive Phase 3 RASolute 302 trial results released in April 2026. In that study, daraxonrasib significantly extended median overall survival to 13.2 months versus 6.7 months with chemotherapy (hazard ratio 0.40) and doubled progression-free survival, with a manageable safety profile and fewer discontinuations. These data, published in the New England Journal of Medicine, prompted the FDA to accept the New Drug Application on July 22, 2026, under the Commissioner’s National Priority Voucher program. Earlier designations—including Breakthrough Therapy and Orphan Drug status—plus the October 2025 national priority voucher and May 2026 expanded-access approval further compress the review timeline. Standard priority reviews often conclude within six months, positioning a potential decision before year-end, though the agency could still request additional data or identify manufacturing or safety issues during inspection. Trader consensus at 65% Yes therefore reflects the strength of the pivotal survival benefit, the expedited regulatory pathway, and the recent NDA acceptance, tempered by the inherent uncertainty of ongoing FDA review and the possibility of delays into 2027. No approval has occurred as of early August 2026.
Експериментальне резюме, згенероване ШІ з посиланням на дані Polymarket. Це не торгова порада і не впливає на вирішення цього ринку. · ОновленоFDA approves Daraxonrasib this year?
FDA approves Daraxonrasib this year?
НОВЕ
НОВЕ
Dec 31, 2026
НОВЕ
НОВЕ
Dec 31, 2026
Daraxonrasib is an RAS inhibitor drug developed by Revolution Medicines and currently in trial to treat RAS-mutated cancers.
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.**Daraxonrasib (RMC-6236), an oral RAS(ON) multi-selective inhibitor developed by Revolution Medicines, targets RAS-addicted cancers, particularly KRAS G12-mutated metastatic pancreatic ductal adenocarcinoma (PDAC).** The current 65% market-implied probability that the FDA will approve it in 2026 is driven primarily by the positive Phase 3 RASolute 302 trial results released in April 2026. In that study, daraxonrasib significantly extended median overall survival to 13.2 months versus 6.7 months with chemotherapy (hazard ratio 0.40) and doubled progression-free survival, with a manageable safety profile and fewer discontinuations.
These data, published in the New England Journal of Medicine, prompted the FDA to accept the New Drug Application on July 22, 2026, under the Commissioner’s National Priority Voucher program. Earlier designations—including Breakthrough Therapy and Orphan Drug status—plus the October 2025 national priority voucher and May 2026 expanded-access approval further compress the review timeline. Standard priority reviews often conclude within six months, positioning a potential decision before year-end, though the agency could still request additional data or identify manufacturing or safety issues during inspection.
Trader consensus at 65% Yes therefore reflects the strength of the pivotal survival benefit, the expedited regulatory pathway, and the recent NDA acceptance, tempered by the inherent uncertainty of ongoing FDA review and the possibility of delays into 2027. No approval has occurred as of early August 2026.
Daraxonrasib is an RAS inhibitor drug developed by Revolution Medicines and currently in trial to treat RAS-mutated cancers.
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.
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.
Ринок відкрито: May 13, 2026, 5:28 PM ET
Обсяг
$2,112Дата завершення
Dec 31, 2026Ринок відкрито
May 13, 2026, 5:28 PM ETResolver
0x65070BE91...Daraxonrasib is an RAS inhibitor drug developed by Revolution Medicines and currently in trial to treat RAS-mutated cancers.
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.**Daraxonrasib (RMC-6236), an oral RAS(ON) multi-selective inhibitor developed by Revolution Medicines, targets RAS-addicted cancers, particularly KRAS G12-mutated metastatic pancreatic ductal adenocarcinoma (PDAC).** The current 65% market-implied probability that the FDA will approve it in 2026 is driven primarily by the positive Phase 3 RASolute 302 trial results released in April 2026. In that study, daraxonrasib significantly extended median overall survival to 13.2 months versus 6.7 months with chemotherapy (hazard ratio 0.40) and doubled progression-free survival, with a manageable safety profile and fewer discontinuations.
These data, published in the New England Journal of Medicine, prompted the FDA to accept the New Drug Application on July 22, 2026, under the Commissioner’s National Priority Voucher program. Earlier designations—including Breakthrough Therapy and Orphan Drug status—plus the October 2025 national priority voucher and May 2026 expanded-access approval further compress the review timeline. Standard priority reviews often conclude within six months, positioning a potential decision before year-end, though the agency could still request additional data or identify manufacturing or safety issues during inspection.
Trader consensus at 65% Yes therefore reflects the strength of the pivotal survival benefit, the expedited regulatory pathway, and the recent NDA acceptance, tempered by the inherent uncertainty of ongoing FDA review and the possibility of delays into 2027. No approval has occurred as of early August 2026.
Daraxonrasib is an RAS inhibitor drug developed by Revolution Medicines and currently in trial to treat RAS-mutated cancers.
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.
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.
Обсяг
$2,112Дата завершення
Dec 31, 2026Ринок відкрито
May 13, 2026, 5:28 PM ETResolver
0x65070BE91...**Daraxonrasib (RMC-6236), an oral RAS(ON) multi-selective inhibitor developed by Revolution Medicines, targets RAS-addicted cancers, particularly KRAS G12-mutated metastatic pancreatic ductal adenocarcinoma (PDAC).** The current 65% market-implied probability that the FDA will approve it in 2026 is driven primarily by the positive Phase 3 RASolute 302 trial results released in April 2026. In that study, daraxonrasib significantly extended median overall survival to 13.2 months versus 6.7 months with chemotherapy (hazard ratio 0.40) and doubled progression-free survival, with a manageable safety profile and fewer discontinuations. These data, published in the New England Journal of Medicine, prompted the FDA to accept the New Drug Application on July 22, 2026, under the Commissioner’s National Priority Voucher program. Earlier designations—including Breakthrough Therapy and Orphan Drug status—plus the October 2025 national priority voucher and May 2026 expanded-access approval further compress the review timeline. Standard priority reviews often conclude within six months, positioning a potential decision before year-end, though the agency could still request additional data or identify manufacturing or safety issues during inspection. Trader consensus at 65% Yes therefore reflects the strength of the pivotal survival benefit, the expedited regulatory pathway, and the recent NDA acceptance, tempered by the inherent uncertainty of ongoing FDA review and the possibility of delays into 2027. No approval has occurred as of early August 2026.
Експериментальне резюме, згенероване ШІ з посиланням на дані Polymarket. Це не торгова порада і не впливає на вирішення цього ринку. · Оновлено
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