The FDA's approval of Sanofi's Dupixent (dupilumab) on February 24, 2026, as the first and only targeted biologic for allergic fungal rhinosinusitis in patients aged 6 and older has driven trader consensus to a near-certain 100% implied probability for "Yes," reflecting Phase 3 trial data showing a 92% reduction in the need for steroids or surgery. This ninth U.S. indication for the interleukin-4 and interleukin-13 inhibitor underscores its expanding label across type 2 inflammatory diseases, backed by Sanofi and Regeneron's official announcements and FDA posting. While revocation or reinterpretation of approval criteria remains a theoretical risk—such as post-marketing safety issues or labeling disputes—such events are exceedingly rare for established biologics with strong safety profiles, cementing market confidence ahead of resolution.
Resumo experimental gerado por IA com dados do Polymarket. Isto não é aconselhamento de trading e não tem qualquer papel na resolução deste mercado. · AtualizadoA FDA aprova o Dupixent da Sanofi?
A FDA aprova o Dupixent da Sanofi?
Sim
$10,142 Vol.
$10,142 Vol.
27 abr 2026
Sim
$10,142 Vol.
$10,142 Vol.
27 abr 2026
As of market creation, the FDA's expected decision date for the specified application is April 27, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Sanofi's Dupixent as a treatment for chronic spontaneous urticaria (CSU) in children by May 11, 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
This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the specified period, the market will resolve to "No" immediately.
If the listed drug is approved before the end of the specified period, 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.The FDA's approval of Sanofi's Dupixent (dupilumab) on February 24, 2026, as the first and only targeted biologic for allergic fungal rhinosinusitis in patients aged 6 and older has driven trader consensus to a near-certain 100% implied probability for "Yes," reflecting Phase 3 trial data showing a 92% reduction in the need for steroids or surgery. This ninth U.S. indication for the interleukin-4 and interleukin-13 inhibitor underscores its expanding label across type 2 inflammatory diseases, backed by Sanofi and Regeneron's official announcements and FDA posting. While revocation or reinterpretation of approval criteria remains a theoretical risk—such as post-marketing safety issues or labeling disputes—such events are exceedingly rare for established biologics with strong safety profiles, cementing market confidence ahead of resolution.
As of market creation, the FDA's expected decision date for the specified application is April 27, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Sanofi's Dupixent as a treatment for chronic spontaneous urticaria (CSU) in children by May 11, 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
This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the specified period, the market will resolve to "No" immediately.
If the listed drug is approved before the end of the specified period, 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 full or conditional approval for Sanofi's Dupixent as a treatment for chronic spontaneous urticaria (CSU) in children by May 11, 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
This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the specified period, the market will resolve to "No" immediately.
If the listed drug is approved before the end of the specified period, 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.
Mercado Aberto: Apr 20, 2026, 5:43 PM ET
Volume
$10,142Data de Término
27 abr 2026Mercado Aberto
Apr 20, 2026, 5:43 PM ETResolver
0x65070BE91...Resultado proposto: Sim
Sem contestação
Resultado final: Sim
As of market creation, the FDA's expected decision date for the specified application is April 27, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Sanofi's Dupixent as a treatment for chronic spontaneous urticaria (CSU) in children by May 11, 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
This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the specified period, the market will resolve to "No" immediately.
If the listed drug is approved before the end of the specified period, 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.The FDA's approval of Sanofi's Dupixent (dupilumab) on February 24, 2026, as the first and only targeted biologic for allergic fungal rhinosinusitis in patients aged 6 and older has driven trader consensus to a near-certain 100% implied probability for "Yes," reflecting Phase 3 trial data showing a 92% reduction in the need for steroids or surgery. This ninth U.S. indication for the interleukin-4 and interleukin-13 inhibitor underscores its expanding label across type 2 inflammatory diseases, backed by Sanofi and Regeneron's official announcements and FDA posting. While revocation or reinterpretation of approval criteria remains a theoretical risk—such as post-marketing safety issues or labeling disputes—such events are exceedingly rare for established biologics with strong safety profiles, cementing market confidence ahead of resolution.
As of market creation, the FDA's expected decision date for the specified application is April 27, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Sanofi's Dupixent as a treatment for chronic spontaneous urticaria (CSU) in children by May 11, 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
This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the specified period, the market will resolve to "No" immediately.
If the listed drug is approved before the end of the specified period, 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 full or conditional approval for Sanofi's Dupixent as a treatment for chronic spontaneous urticaria (CSU) in children by May 11, 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
This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the specified period, the market will resolve to "No" immediately.
If the listed drug is approved before the end of the specified period, 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.
Volume
$10,142Data de Término
27 abr 2026Mercado Aberto
Apr 20, 2026, 5:43 PM ETResolver
0x65070BE91...Resultado proposto: Sim
Sem contestação
Resultado final: Sim
The FDA's approval of Sanofi's Dupixent (dupilumab) on February 24, 2026, as the first and only targeted biologic for allergic fungal rhinosinusitis in patients aged 6 and older has driven trader consensus to a near-certain 100% implied probability for "Yes," reflecting Phase 3 trial data showing a 92% reduction in the need for steroids or surgery. This ninth U.S. indication for the interleukin-4 and interleukin-13 inhibitor underscores its expanding label across type 2 inflammatory diseases, backed by Sanofi and Regeneron's official announcements and FDA posting. While revocation or reinterpretation of approval criteria remains a theoretical risk—such as post-marketing safety issues or labeling disputes—such events are exceedingly rare for established biologics with strong safety profiles, cementing market confidence ahead of resolution.
Resumo experimental gerado por IA com dados do Polymarket. Isto não é aconselhamento de trading e não tem qualquer papel na resolução deste mercado. · Atualizado
Cuidado com os links externos.
Cuidado com os links externos.
Frequently Asked Questions