The FDA's extension of the PDUFA target action date for Sanofi's subcutaneous Sarclisa (isatuximab-irfc) biologics license application from April 23 to July 23, 2026—announced by Sanofi on April 22—has driven near-unanimous trader consensus at 97.5% for "No," as this timeline exceeds the market's May 7 resolution deadline. The extension stems from additional FDA scrutiny of the on-body injector device, with no noted safety or efficacy concerns for the drug itself, which demonstrated bioequivalence to the approved intravenous formulation in the IRAKLIA phase 3 trial for relapsed/refractory and newly diagnosed multiple myeloma patients. While positive CHMP recommendation supports EU approval, realistic scenarios for U.S. approval by May 7 are negligible absent an unprecedented early decision, historical precedents for which are rare in extended reviews. Traders await formal resolution post-deadline.
Resumen experimental generado por IA con datos de Polymarket. Esto no es asesoramiento de trading y no influye en cómo se resuelve este mercado. · ActualizadoSí
$7,895 Vol.
$7,895 Vol.
23 abr 2026
Sí
$7,895 Vol.
$7,895 Vol.
23 abr 2026
As of market creation, the FDA’s expected decision date for the specified application is April 23, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Sanofi’s Subcutaneous Sarclisa as a treatment for multiple myeloma by May 7, 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 extension of the PDUFA target action date for Sanofi's subcutaneous Sarclisa (isatuximab-irfc) biologics license application from April 23 to July 23, 2026—announced by Sanofi on April 22—has driven near-unanimous trader consensus at 97.5% for "No," as this timeline exceeds the market's May 7 resolution deadline. The extension stems from additional FDA scrutiny of the on-body injector device, with no noted safety or efficacy concerns for the drug itself, which demonstrated bioequivalence to the approved intravenous formulation in the IRAKLIA phase 3 trial for relapsed/refractory and newly diagnosed multiple myeloma patients. While positive CHMP recommendation supports EU approval, realistic scenarios for U.S. approval by May 7 are negligible absent an unprecedented early decision, historical precedents for which are rare in extended reviews. Traders await formal resolution post-deadline.
As of market creation, the FDA’s expected decision date for the specified application is April 23, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Sanofi’s Subcutaneous Sarclisa as a treatment for multiple myeloma by May 7, 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 Subcutaneous Sarclisa as a treatment for multiple myeloma by May 7, 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 abierto: Apr 17, 2026, 4:15 PM ET
Volumen
$7,895Fecha de finalización
23 abr 2026Mercado abierto
Apr 17, 2026, 4:15 PM ETResolver
0x65070BE91...As of market creation, the FDA’s expected decision date for the specified application is April 23, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Sanofi’s Subcutaneous Sarclisa as a treatment for multiple myeloma by May 7, 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 extension of the PDUFA target action date for Sanofi's subcutaneous Sarclisa (isatuximab-irfc) biologics license application from April 23 to July 23, 2026—announced by Sanofi on April 22—has driven near-unanimous trader consensus at 97.5% for "No," as this timeline exceeds the market's May 7 resolution deadline. The extension stems from additional FDA scrutiny of the on-body injector device, with no noted safety or efficacy concerns for the drug itself, which demonstrated bioequivalence to the approved intravenous formulation in the IRAKLIA phase 3 trial for relapsed/refractory and newly diagnosed multiple myeloma patients. While positive CHMP recommendation supports EU approval, realistic scenarios for U.S. approval by May 7 are negligible absent an unprecedented early decision, historical precedents for which are rare in extended reviews. Traders await formal resolution post-deadline.
As of market creation, the FDA’s expected decision date for the specified application is April 23, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Sanofi’s Subcutaneous Sarclisa as a treatment for multiple myeloma by May 7, 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 Subcutaneous Sarclisa as a treatment for multiple myeloma by May 7, 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.
Volumen
$7,895Fecha de finalización
23 abr 2026Mercado abierto
Apr 17, 2026, 4:15 PM ETResolver
0x65070BE91...The FDA's extension of the PDUFA target action date for Sanofi's subcutaneous Sarclisa (isatuximab-irfc) biologics license application from April 23 to July 23, 2026—announced by Sanofi on April 22—has driven near-unanimous trader consensus at 97.5% for "No," as this timeline exceeds the market's May 7 resolution deadline. The extension stems from additional FDA scrutiny of the on-body injector device, with no noted safety or efficacy concerns for the drug itself, which demonstrated bioequivalence to the approved intravenous formulation in the IRAKLIA phase 3 trial for relapsed/refractory and newly diagnosed multiple myeloma patients. While positive CHMP recommendation supports EU approval, realistic scenarios for U.S. approval by May 7 are negligible absent an unprecedented early decision, historical precedents for which are rare in extended reviews. Traders await formal resolution post-deadline.
Resumen experimental generado por IA con datos de Polymarket. Esto no es asesoramiento de trading y no influye en cómo se resuelve este mercado. · Actualizado
Cuidado con los enlaces externos.
Cuidado con los enlaces externos.
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