Trader consensus prices a 67.5% implied probability on FDA approval of Sanofi's Tzield (teplizumab-mzwv) sBLA, driven by the PDUFA target date just one week away on April 29, 2026, for expanding the CD3-directed monoclonal antibody to children aged 1-7 years with stage 2 type 1 diabetes. This reflects the therapy's proven efficacy in delaying stage 3 onset since its original 2022 approval, bolstered by positive PETITE-T1D study data and priority review via a rare disease voucher, signaling regulatory recognition of unmet pediatric need. Recent FDA acceptance of the filing on January 5 tempers prior delays from safety scrutiny—including a reported treatment-related death—but no fresh adverse signals have emerged, sustaining optimism amid historical biotech approval precedents where proximity to decision boosts odds.
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
NUEVO
NUEVO
29 abr 2026
Sí
NUEVO
NUEVO
29 abr 2026
As of market creation, the FDA's expected decision date for the specified application is April 29, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Sanofi's Tzield as a treatment for delaying the onset of stage 3 type 1 diabetes in patients aged 1 year and older with stage 2 type 1 diabetes by May 13, 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 prices a 67.5% implied probability on FDA approval of Sanofi's Tzield (teplizumab-mzwv) sBLA, driven by the PDUFA target date just one week away on April 29, 2026, for expanding the CD3-directed monoclonal antibody to children aged 1-7 years with stage 2 type 1 diabetes. This reflects the therapy's proven efficacy in delaying stage 3 onset since its original 2022 approval, bolstered by positive PETITE-T1D study data and priority review via a rare disease voucher, signaling regulatory recognition of unmet pediatric need. Recent FDA acceptance of the filing on January 5 tempers prior delays from safety scrutiny—including a reported treatment-related death—but no fresh adverse signals have emerged, sustaining optimism amid historical biotech approval precedents where proximity to decision boosts odds.
As of market creation, the FDA's expected decision date for the specified application is April 29, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Sanofi's Tzield as a treatment for delaying the onset of stage 3 type 1 diabetes in patients aged 1 year and older with stage 2 type 1 diabetes by May 13, 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 Tzield as a treatment for delaying the onset of stage 3 type 1 diabetes in patients aged 1 year and older with stage 2 type 1 diabetes by May 13, 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 20, 2026, 5:44 PM ET
Volumen
$17Fecha de finalización
29 abr 2026Mercado abierto
Apr 20, 2026, 5:44 PM ETResolver
0x65070BE91...As of market creation, the FDA's expected decision date for the specified application is April 29, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Sanofi's Tzield as a treatment for delaying the onset of stage 3 type 1 diabetes in patients aged 1 year and older with stage 2 type 1 diabetes by May 13, 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 prices a 67.5% implied probability on FDA approval of Sanofi's Tzield (teplizumab-mzwv) sBLA, driven by the PDUFA target date just one week away on April 29, 2026, for expanding the CD3-directed monoclonal antibody to children aged 1-7 years with stage 2 type 1 diabetes. This reflects the therapy's proven efficacy in delaying stage 3 onset since its original 2022 approval, bolstered by positive PETITE-T1D study data and priority review via a rare disease voucher, signaling regulatory recognition of unmet pediatric need. Recent FDA acceptance of the filing on January 5 tempers prior delays from safety scrutiny—including a reported treatment-related death—but no fresh adverse signals have emerged, sustaining optimism amid historical biotech approval precedents where proximity to decision boosts odds.
As of market creation, the FDA's expected decision date for the specified application is April 29, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Sanofi's Tzield as a treatment for delaying the onset of stage 3 type 1 diabetes in patients aged 1 year and older with stage 2 type 1 diabetes by May 13, 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 Tzield as a treatment for delaying the onset of stage 3 type 1 diabetes in patients aged 1 year and older with stage 2 type 1 diabetes by May 13, 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
$18Fecha de finalización
29 abr 2026Mercado abierto
Apr 20, 2026, 5:44 PM ETResolver
0x65070BE91...Trader consensus prices a 67.5% implied probability on FDA approval of Sanofi's Tzield (teplizumab-mzwv) sBLA, driven by the PDUFA target date just one week away on April 29, 2026, for expanding the CD3-directed monoclonal antibody to children aged 1-7 years with stage 2 type 1 diabetes. This reflects the therapy's proven efficacy in delaying stage 3 onset since its original 2022 approval, bolstered by positive PETITE-T1D study data and priority review via a rare disease voucher, signaling regulatory recognition of unmet pediatric need. Recent FDA acceptance of the filing on January 5 tempers prior delays from safety scrutiny—including a reported treatment-related death—but no fresh adverse signals have emerged, sustaining optimism amid historical biotech approval precedents where proximity to decision boosts odds.
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
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Cuidado con los enlaces externos.
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