Strong Phase 3 RASolute 302 results released in April 2026, showing daraxonrasib nearly doubling median overall survival to 13.2 months versus 6.7 months with chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), drove the 65.5% market-implied probability of FDA approval this year. The oral RAS(ON) multi-selective inhibitor delivered statistically significant gains in progression-free survival and quality-of-life measures with a manageable safety profile in RAS-mutated tumors, prompting rapid FDA actions including expanded access authorization in May and NDA acceptance in July under the Commissioner’s National Priority Voucher program. Breakthrough therapy and orphan drug designations, combined with pancreatic cancer’s high unmet need, support an accelerated review timeline that could allow approval before year-end, though the standard 10-month clock and any manufacturing or labeling reviews introduce realistic uncertainty. Traders weigh these positive registrational data and expedited regulatory signals against the typical lag between NDA filing and final decision.
Экспериментальная сводка, созданная ИИ на основе данных Polymarket. Это не является торговой рекомендацией и не влияет на то, как разрешается этот рынок. · ОбновленоFDA одобряет Дараксонрасиб в этом году?
FDA одобряет Дараксонрасиб в этом году?
Да
НОВОЕ
НОВОЕ
31 дек. 2026 г.
Да
НОВОЕ
НОВОЕ
31 дек. 2026 г.
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.Strong Phase 3 RASolute 302 results released in April 2026, showing daraxonrasib nearly doubling median overall survival to 13.2 months versus 6.7 months with chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), drove the 65.5% market-implied probability of FDA approval this year. The oral RAS(ON) multi-selective inhibitor delivered statistically significant gains in progression-free survival and quality-of-life measures with a manageable safety profile in RAS-mutated tumors, prompting rapid FDA actions including expanded access authorization in May and NDA acceptance in July under the Commissioner’s National Priority Voucher program. Breakthrough therapy and orphan drug designations, combined with pancreatic cancer’s high unmet need, support an accelerated review timeline that could allow approval before year-end, though the standard 10-month clock and any manufacturing or labeling reviews introduce realistic uncertainty. Traders weigh these positive registrational data and expedited regulatory signals against the typical lag between NDA filing and final decision.
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.
Открытие рынка: May 13, 2026, 5:28 PM ET
Объем
$2,112Дата окончания
31 дек. 2026 г.Открытие рынка
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.Strong Phase 3 RASolute 302 results released in April 2026, showing daraxonrasib nearly doubling median overall survival to 13.2 months versus 6.7 months with chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), drove the 65.5% market-implied probability of FDA approval this year. The oral RAS(ON) multi-selective inhibitor delivered statistically significant gains in progression-free survival and quality-of-life measures with a manageable safety profile in RAS-mutated tumors, prompting rapid FDA actions including expanded access authorization in May and NDA acceptance in July under the Commissioner’s National Priority Voucher program. Breakthrough therapy and orphan drug designations, combined with pancreatic cancer’s high unmet need, support an accelerated review timeline that could allow approval before year-end, though the standard 10-month clock and any manufacturing or labeling reviews introduce realistic uncertainty. Traders weigh these positive registrational data and expedited regulatory signals against the typical lag between NDA filing and final decision.
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.
Объем
$2,112Дата окончания
31 дек. 2026 г.Открытие рынка
May 13, 2026, 5:28 PM ETResolver
0x65070BE91...Strong Phase 3 RASolute 302 results released in April 2026, showing daraxonrasib nearly doubling median overall survival to 13.2 months versus 6.7 months with chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), drove the 65.5% market-implied probability of FDA approval this year. The oral RAS(ON) multi-selective inhibitor delivered statistically significant gains in progression-free survival and quality-of-life measures with a manageable safety profile in RAS-mutated tumors, prompting rapid FDA actions including expanded access authorization in May and NDA acceptance in July under the Commissioner’s National Priority Voucher program. Breakthrough therapy and orphan drug designations, combined with pancreatic cancer’s high unmet need, support an accelerated review timeline that could allow approval before year-end, though the standard 10-month clock and any manufacturing or labeling reviews introduce realistic uncertainty. Traders weigh these positive registrational data and expedited regulatory signals against the typical lag between NDA filing and final decision.
Экспериментальная сводка, созданная ИИ на основе данных Polymarket. Это не является торговой рекомендацией и не влияет на то, как разрешается этот рынок. · Обновлено
Не доверяй внешним ссылкам.
Не доверяй внешним ссылкам.
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