Strong Phase III results from the DESTINY-Breast05 trial, demonstrating a 53% reduction in invasive disease recurrence or death versus T-DM1, have driven the 97% market-implied probability that the FDA will approve Enhertu for post-neoadjuvant treatment of HER2-positive early breast cancer with residual disease. The supplemental biologics license application received Priority Review and Breakthrough Therapy Designation in March 2026, with a PDUFA target of July 2026, reflecting the therapy’s clear efficacy edge in this setting. AstraZeneca and Daiichi Sankyo’s established manufacturing and regulatory track record further supports trader consensus. While delays from manufacturing scale-up or unexpected safety signals remain possible, the depth of the clinical data and accelerated review timeline make such outcomes highly improbable.
基於Polymarket數據的AI實驗性摘要。這不是交易建議，也不影響該市場的結算方式。 · 更新於是
最新
最新
2026-05-18
是
最新
最新
2026-05-18
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.Strong Phase III results from the DESTINY-Breast05 trial, demonstrating a 53% reduction in invasive disease recurrence or death versus T-DM1, have driven the 97% market-implied probability that the FDA will approve Enhertu for post-neoadjuvant treatment of HER2-positive early breast cancer with residual disease. The supplemental biologics license application received Priority Review and Breakthrough Therapy Designation in March 2026, with a PDUFA target of July 2026, reflecting the therapy’s clear efficacy edge in this setting. AstraZeneca and Daiichi Sankyo’s established manufacturing and regulatory track record further supports trader consensus. While delays from manufacturing scale-up or unexpected safety signals remain possible, the depth of the clinical data and accelerated review timeline make such outcomes highly improbable.
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.
市場開放時間： Apr 29, 2026, 8:06 PM ET
交易量
$1,768結束日期
2026-05-18市場開放時間
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.Strong Phase III results from the DESTINY-Breast05 trial, demonstrating a 53% reduction in invasive disease recurrence or death versus T-DM1, have driven the 97% market-implied probability that the FDA will approve Enhertu for post-neoadjuvant treatment of HER2-positive early breast cancer with residual disease. The supplemental biologics license application received Priority Review and Breakthrough Therapy Designation in March 2026, with a PDUFA target of July 2026, reflecting the therapy’s clear efficacy edge in this setting. AstraZeneca and Daiichi Sankyo’s established manufacturing and regulatory track record further supports trader consensus. While delays from manufacturing scale-up or unexpected safety signals remain possible, the depth of the clinical data and accelerated review timeline make such outcomes highly improbable.
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.
交易量
$1,768結束日期
2026-05-18市場開放時間
Apr 29, 2026, 8:06 PM ETResolver
0x65070BE91...Strong Phase III results from the DESTINY-Breast05 trial, demonstrating a 53% reduction in invasive disease recurrence or death versus T-DM1, have driven the 97% market-implied probability that the FDA will approve Enhertu for post-neoadjuvant treatment of HER2-positive early breast cancer with residual disease. The supplemental biologics license application received Priority Review and Breakthrough Therapy Designation in March 2026, with a PDUFA target of July 2026, reflecting the therapy’s clear efficacy edge in this setting. AstraZeneca and Daiichi Sankyo’s established manufacturing and regulatory track record further supports trader consensus. While delays from manufacturing scale-up or unexpected safety signals remain possible, the depth of the clinical data and accelerated review timeline make such outcomes highly improbable.
基於Polymarket數據的AI實驗性摘要。這不是交易建議，也不影響該市場的結算方式。 · 更新於
警惕外部連結哦。
警惕外部連結哦。
Frequently Asked Questions