Strong Phase III results from the DESTINY-Breast05 trial, showing a 53% reduction in invasive disease recurrence or death versus T-DM1, combined with the FDA’s March 2026 Priority Review and December 2025 Breakthrough Therapy Designation, have driven the 97% implied probability for approval of Enhertu in HER2-positive early breast cancer with residual disease after neoadjuvant therapy. Traders cite Enhertu’s established safety profile in prior metastatic approvals, consistent efficacy signals across antibody-drug conjugate data, and the absence of major competing safety concerns as reinforcing factors. The supplemental biologics license application targets a potential new standard of care, with a July 2026 PDUFA target date and Project Orbis review accelerating timelines. Remaining uncertainty centers on possible last-minute manufacturing or labeling queries, though historical precedent for similar agents indicates these rarely alter near-term outcomes.
Tóm tắt AI thử nghiệm tham chiếu dữ liệu Polymarket. Đây không phải tư vấn giao dịch và không ảnh hưởng đến cách thị trường này được giải quyết. · Cập nhật$2,031 KL.
$2,031 KL.
May 18, 2026
$2,031 KL.
$2,031 KL.
May 18, 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.Strong Phase III results from the DESTINY-Breast05 trial, showing a 53% reduction in invasive disease recurrence or death versus T-DM1, combined with the FDA’s March 2026 Priority Review and December 2025 Breakthrough Therapy Designation, have driven the 97% implied probability for approval of Enhertu in HER2-positive early breast cancer with residual disease after neoadjuvant therapy. Traders cite Enhertu’s established safety profile in prior metastatic approvals, consistent efficacy signals across antibody-drug conjugate data, and the absence of major competing safety concerns as reinforcing factors. The supplemental biologics license application targets a potential new standard of care, with a July 2026 PDUFA target date and Project Orbis review accelerating timelines. Remaining uncertainty centers on possible last-minute manufacturing or labeling queries, though historical precedent for similar agents indicates these rarely alter near-term outcomes.
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.
Thị trường mở: Apr 29, 2026, 8:06 PM ET
Khối lượng
$2,031Ngày kết thúc
May 18, 2026Thị trường mở
Apr 29, 2026, 8:06 PM ETResolver
0x65070BE91...Kết quả đề xuất: Yes
Không tranh chấp
Kết quả cuối cùng: Yes
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, showing a 53% reduction in invasive disease recurrence or death versus T-DM1, combined with the FDA’s March 2026 Priority Review and December 2025 Breakthrough Therapy Designation, have driven the 97% implied probability for approval of Enhertu in HER2-positive early breast cancer with residual disease after neoadjuvant therapy. Traders cite Enhertu’s established safety profile in prior metastatic approvals, consistent efficacy signals across antibody-drug conjugate data, and the absence of major competing safety concerns as reinforcing factors. The supplemental biologics license application targets a potential new standard of care, with a July 2026 PDUFA target date and Project Orbis review accelerating timelines. Remaining uncertainty centers on possible last-minute manufacturing or labeling queries, though historical precedent for similar agents indicates these rarely alter near-term outcomes.
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.
Khối lượng
$2,031Ngày kết thúc
May 18, 2026Thị trường mở
Apr 29, 2026, 8:06 PM ETResolver
0x65070BE91...Kết quả đề xuất: Yes
Không tranh chấp
Kết quả cuối cùng: Yes
Strong Phase III results from the DESTINY-Breast05 trial, showing a 53% reduction in invasive disease recurrence or death versus T-DM1, combined with the FDA’s March 2026 Priority Review and December 2025 Breakthrough Therapy Designation, have driven the 97% implied probability for approval of Enhertu in HER2-positive early breast cancer with residual disease after neoadjuvant therapy. Traders cite Enhertu’s established safety profile in prior metastatic approvals, consistent efficacy signals across antibody-drug conjugate data, and the absence of major competing safety concerns as reinforcing factors. The supplemental biologics license application targets a potential new standard of care, with a July 2026 PDUFA target date and Project Orbis review accelerating timelines. Remaining uncertainty centers on possible last-minute manufacturing or labeling queries, though historical precedent for similar agents indicates these rarely alter near-term outcomes.
Tóm tắt AI thử nghiệm tham chiếu dữ liệu Polymarket. Đây không phải tư vấn giao dịch và không ảnh hưởng đến cách thị trường này được giải quyết. · Cập nhật
Cẩn thận với liên kết bên ngoài.
Cẩn thận với liên kết bên ngoài.
Câu hỏi thường gặp