Trader consensus reflects near-certainty at 99.7% for "No" following the FDA's April 22, 2026, announcement extending review of Sanofi's biologics license application for subcutaneous Sarclisa (isatuximab-irfc), an anti-CD38 monoclonal antibody for multiple myeloma. The Prescription Drug User Fee Act target date shifted from April 23 to July 23, 2026, to allow additional evaluation time, despite positive phase 3 data showing pharmacokinetic non-inferiority and similar efficacy to the approved intravenous formulation via on-body injector. No approval has been posted on official FDA channels, solidifying the outcome as the market's resolution criteria—tied to the original timeline—remain unmet. Realistic shifts would require an unforeseen expedited approval before close, though routine extensions signal low likelihood amid standard regulatory caution.
Экспериментальная сводка, созданная ИИ на основе данных Polymarket. Это не является торговой рекомендацией и не влияет на то, как разрешается этот рынок. · ОбновленоУправление по санитарному надзору за качеством пищевых продуктов и медикаментов США (FDA) одобряет подкожную сар
Управление по санитарному надзору за качеством пищевых продуктов и медикаментов США (FDA) одобряет подкожную сар
Да
$10,880 Объем
$10,880 Объем
23 апр. 2026 г.
Да
$10,880 Объем
$10,880 Объем
23 апр. 2026 г.
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.Trader consensus reflects near-certainty at 99.7% for "No" following the FDA's April 22, 2026, announcement extending review of Sanofi's biologics license application for subcutaneous Sarclisa (isatuximab-irfc), an anti-CD38 monoclonal antibody for multiple myeloma. The Prescription Drug User Fee Act target date shifted from April 23 to July 23, 2026, to allow additional evaluation time, despite positive phase 3 data showing pharmacokinetic non-inferiority and similar efficacy to the approved intravenous formulation via on-body injector. No approval has been posted on official FDA channels, solidifying the outcome as the market's resolution criteria—tied to the original timeline—remain unmet. Realistic shifts would require an unforeseen expedited approval before close, though routine extensions signal low likelihood amid standard regulatory caution.
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.
Открытие рынка: Apr 17, 2026, 4:15 PM ET
Объем
$10,880Дата окончания
23 апр. 2026 г.Открытие рынка
Apr 17, 2026, 4:15 PM ETResolver
0x65070BE91...Предложенный исход: Нет
Спор отсутствует
Окончательный исход: Нет
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.Trader consensus reflects near-certainty at 99.7% for "No" following the FDA's April 22, 2026, announcement extending review of Sanofi's biologics license application for subcutaneous Sarclisa (isatuximab-irfc), an anti-CD38 monoclonal antibody for multiple myeloma. The Prescription Drug User Fee Act target date shifted from April 23 to July 23, 2026, to allow additional evaluation time, despite positive phase 3 data showing pharmacokinetic non-inferiority and similar efficacy to the approved intravenous formulation via on-body injector. No approval has been posted on official FDA channels, solidifying the outcome as the market's resolution criteria—tied to the original timeline—remain unmet. Realistic shifts would require an unforeseen expedited approval before close, though routine extensions signal low likelihood amid standard regulatory caution.
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.
Объем
$10,880Дата окончания
23 апр. 2026 г.Открытие рынка
Apr 17, 2026, 4:15 PM ETResolver
0x65070BE91...Предложенный исход: Нет
Спор отсутствует
Окончательный исход: Нет
Trader consensus reflects near-certainty at 99.7% for "No" following the FDA's April 22, 2026, announcement extending review of Sanofi's biologics license application for subcutaneous Sarclisa (isatuximab-irfc), an anti-CD38 monoclonal antibody for multiple myeloma. The Prescription Drug User Fee Act target date shifted from April 23 to July 23, 2026, to allow additional evaluation time, despite positive phase 3 data showing pharmacokinetic non-inferiority and similar efficacy to the approved intravenous formulation via on-body injector. No approval has been posted on official FDA channels, solidifying the outcome as the market's resolution criteria—tied to the original timeline—remain unmet. Realistic shifts would require an unforeseen expedited approval before close, though routine extensions signal low likelihood amid standard regulatory caution.
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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