Trader consensus on an 82.5% implied probability for FDA approval of Daiichi Sankyo and AstraZeneca's Enhertu reflects robust phase 3 DESTINY-Breast11 data demonstrating superior pathologic complete response rates (67.3% vs. 56.3%) for Enhertu followed by paclitaxel, trastuzumab, and pertuzumab in high-risk HER2-positive early breast cancer, compared to standard chemotherapy. The supplemental Biologics License Application, accepted in late 2025, nears its PDUFA target action date of May 18, 2026, with no advisory committee or complete response letter signaled. Enhertu's track record of rapid label expansions—including recent first-line metastatic approvals—bolsters confidence in this antibody-drug conjugate's safety and efficacy profile, though minor labeling adjustments remain a slim risk.
Résumé expérimental généré par IA à partir des données Polymarket. Ceci n'est pas un conseil de trading et ne joue aucun rôle dans la résolution de ce marché. · Mis à jourOui
NOUVEAU
NOUVEAU
18 mai 2026
Oui
NOUVEAU
NOUVEAU
18 mai 2026
As of market creation, the FDA's expected decision date for the specified application is May 18, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Daiichi Sankyo & AstraZeneca's Enhertu as a treatment for neoadjuvant treatment of adult patients with HER2-positive breast cancer by June 1, 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 on an 82.5% implied probability for FDA approval of Daiichi Sankyo and AstraZeneca's Enhertu reflects robust phase 3 DESTINY-Breast11 data demonstrating superior pathologic complete response rates (67.3% vs. 56.3%) for Enhertu followed by paclitaxel, trastuzumab, and pertuzumab in high-risk HER2-positive early breast cancer, compared to standard chemotherapy. The supplemental Biologics License Application, accepted in late 2025, nears its PDUFA target action date of May 18, 2026, with no advisory committee or complete response letter signaled. Enhertu's track record of rapid label expansions—including recent first-line metastatic approvals—bolsters confidence in this antibody-drug conjugate's safety and efficacy profile, though minor labeling adjustments remain a slim risk.
As of market creation, the FDA's expected decision date for the specified application is May 18, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Daiichi Sankyo & AstraZeneca's Enhertu as a treatment for neoadjuvant treatment of adult patients with HER2-positive breast cancer by June 1, 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 Daiichi Sankyo & AstraZeneca's Enhertu as a treatment for neoadjuvant treatment of adult patients with HER2-positive breast cancer by June 1, 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.
Marché ouvert : Apr 29, 2026, 8:06 PM ET
Volume
$289Date de fin
18 mai 2026Marché ouvert
Apr 29, 2026, 8:06 PM ETResolver
0x65070BE91...As of market creation, the FDA's expected decision date for the specified application is May 18, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Daiichi Sankyo & AstraZeneca's Enhertu as a treatment for neoadjuvant treatment of adult patients with HER2-positive breast cancer by June 1, 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 on an 82.5% implied probability for FDA approval of Daiichi Sankyo and AstraZeneca's Enhertu reflects robust phase 3 DESTINY-Breast11 data demonstrating superior pathologic complete response rates (67.3% vs. 56.3%) for Enhertu followed by paclitaxel, trastuzumab, and pertuzumab in high-risk HER2-positive early breast cancer, compared to standard chemotherapy. The supplemental Biologics License Application, accepted in late 2025, nears its PDUFA target action date of May 18, 2026, with no advisory committee or complete response letter signaled. Enhertu's track record of rapid label expansions—including recent first-line metastatic approvals—bolsters confidence in this antibody-drug conjugate's safety and efficacy profile, though minor labeling adjustments remain a slim risk.
As of market creation, the FDA's expected decision date for the specified application is May 18, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Daiichi Sankyo & AstraZeneca's Enhertu as a treatment for neoadjuvant treatment of adult patients with HER2-positive breast cancer by June 1, 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 Daiichi Sankyo & AstraZeneca's Enhertu as a treatment for neoadjuvant treatment of adult patients with HER2-positive breast cancer by June 1, 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
$289Date de fin
18 mai 2026Marché ouvert
Apr 29, 2026, 8:06 PM ETResolver
0x65070BE91...Trader consensus on an 82.5% implied probability for FDA approval of Daiichi Sankyo and AstraZeneca's Enhertu reflects robust phase 3 DESTINY-Breast11 data demonstrating superior pathologic complete response rates (67.3% vs. 56.3%) for Enhertu followed by paclitaxel, trastuzumab, and pertuzumab in high-risk HER2-positive early breast cancer, compared to standard chemotherapy. The supplemental Biologics License Application, accepted in late 2025, nears its PDUFA target action date of May 18, 2026, with no advisory committee or complete response letter signaled. Enhertu's track record of rapid label expansions—including recent first-line metastatic approvals—bolsters confidence in this antibody-drug conjugate's safety and efficacy profile, though minor labeling adjustments remain a slim risk.
Résumé expérimental généré par IA à partir des données Polymarket. Ceci n'est pas un conseil de trading et ne joue aucun rôle dans la résolution de ce marché. · Mis à jour
Méfiez-vous des liens externes.
Méfiez-vous des liens externes.
Questions fréquentes