Positive Phase 3 RASolute 302 trial data released in mid-April 2026, showing daraxonrasib—a RAS(ON) multi-selective inhibitor—extended median overall survival to 13.2 months versus 6.7 months with chemotherapy in pretreated metastatic pancreatic ductal adenocarcinoma, drove the 70.5% implied probability for FDA approval this year. The results met all primary and key secondary endpoints, prompting Revolution Medicines to pursue an NDA submission under the Commissioner’s National Priority Voucher pilot program, which targets review within one to two months of filing. Breakthrough Therapy and Orphan Drug designations, combined with the FDA’s rapid “safe to proceed” authorization for an expanded access protocol on May 1, signal strong regulatory engagement and alignment with national health priorities. Data presentation at the 2026 ASCO meeting and expected NDA filing later this spring position the application for potential approval before year-end, though final agency review timelines remain subject to data completeness.
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.Positive Phase 3 RASolute 302 trial data released in mid-April 2026, showing daraxonrasib—a RAS(ON) multi-selective inhibitor—extended median overall survival to 13.2 months versus 6.7 months with chemotherapy in pretreated metastatic pancreatic ductal adenocarcinoma, drove the 70.5% implied probability for FDA approval this year. The results met all primary and key secondary endpoints, prompting Revolution Medicines to pursue an NDA submission under the Commissioner’s National Priority Voucher pilot program, which targets review within one to two months of filing. Breakthrough Therapy and Orphan Drug designations, combined with the FDA’s rapid “safe to proceed” authorization for an expanded access protocol on May 1, signal strong regulatory engagement and alignment with national health priorities. Data presentation at the 2026 ASCO meeting and expected NDA filing later this spring position the application for potential approval before year-end, though final agency review timelines remain subject to data completeness.
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
$56Дата 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.Positive Phase 3 RASolute 302 trial data released in mid-April 2026, showing daraxonrasib—a RAS(ON) multi-selective inhibitor—extended median overall survival to 13.2 months versus 6.7 months with chemotherapy in pretreated metastatic pancreatic ductal adenocarcinoma, drove the 70.5% implied probability for FDA approval this year. The results met all primary and key secondary endpoints, prompting Revolution Medicines to pursue an NDA submission under the Commissioner’s National Priority Voucher pilot program, which targets review within one to two months of filing. Breakthrough Therapy and Orphan Drug designations, combined with the FDA’s rapid “safe to proceed” authorization for an expanded access protocol on May 1, signal strong regulatory engagement and alignment with national health priorities. Data presentation at the 2026 ASCO meeting and expected NDA filing later this spring position the application for potential approval before year-end, though final agency review timelines remain subject to data completeness.
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
$56Дата завершення
Dec 31, 2026Ринок відкрито
May 13, 2026, 5:28 PM ETResolver
0x65070BE91...Positive Phase 3 RASolute 302 trial data released in mid-April 2026, showing daraxonrasib—a RAS(ON) multi-selective inhibitor—extended median overall survival to 13.2 months versus 6.7 months with chemotherapy in pretreated metastatic pancreatic ductal adenocarcinoma, drove the 70.5% implied probability for FDA approval this year. The results met all primary and key secondary endpoints, prompting Revolution Medicines to pursue an NDA submission under the Commissioner’s National Priority Voucher pilot program, which targets review within one to two months of filing. Breakthrough Therapy and Orphan Drug designations, combined with the FDA’s rapid “safe to proceed” authorization for an expanded access protocol on May 1, signal strong regulatory engagement and alignment with national health priorities. Data presentation at the 2026 ASCO meeting and expected NDA filing later this spring position the application for potential approval before year-end, though final agency review timelines remain subject to data completeness.
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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