Trader consensus prices "Yes" at 79% implied probability for FDA approval of Daiichi Sankyo and AstraZeneca's Enhertu supplemental biologics license application, driven by compelling DESTINY-Breast05 Phase III data showing a 53% reduction in invasive disease-free survival risk versus standard T-DM1 in post-neoadjuvant HER2-positive early breast cancer patients with residual disease. The FDA's Priority Review designation on March 9, 2026—following Breakthrough Therapy status in December 2025—has fast-tracked review, with PDUFA target action date of May 18, just days away. Enhertu's established safety profile and prior metastatic breast cancer approvals bolster optimism, though potential interstitial lung disease concerns could prompt labeling adjustments or rare delays. No recent setbacks have emerged to erode sentiment.
Експериментальне резюме, згенероване ШІ з посиланням на дані Polymarket. Це не торгова порада і не впливає на вирішення цього ринку. · ОновленоFDA approves Daiichi Sankyo & AstraZeneca's Enhertu?
FDA approves Daiichi Sankyo & AstraZeneca's Enhertu?
НОВЕ
НОВЕ
May 18, 2026
НОВЕ
НОВЕ
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.Trader consensus prices "Yes" at 79% implied probability for FDA approval of Daiichi Sankyo and AstraZeneca's Enhertu supplemental biologics license application, driven by compelling DESTINY-Breast05 Phase III data showing a 53% reduction in invasive disease-free survival risk versus standard T-DM1 in post-neoadjuvant HER2-positive early breast cancer patients with residual disease. The FDA's Priority Review designation on March 9, 2026—following Breakthrough Therapy status in December 2025—has fast-tracked review, with PDUFA target action date of May 18, just days away. Enhertu's established safety profile and prior metastatic breast cancer approvals bolster optimism, though potential interstitial lung disease concerns could prompt labeling adjustments or rare delays. No recent setbacks have emerged to erode sentiment.
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.
Ринок відкрито: Apr 29, 2026, 8:06 PM ET
Обсяг
$769Дата завершення
May 18, 2026Ринок відкрито
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 prices "Yes" at 79% implied probability for FDA approval of Daiichi Sankyo and AstraZeneca's Enhertu supplemental biologics license application, driven by compelling DESTINY-Breast05 Phase III data showing a 53% reduction in invasive disease-free survival risk versus standard T-DM1 in post-neoadjuvant HER2-positive early breast cancer patients with residual disease. The FDA's Priority Review designation on March 9, 2026—following Breakthrough Therapy status in December 2025—has fast-tracked review, with PDUFA target action date of May 18, just days away. Enhertu's established safety profile and prior metastatic breast cancer approvals bolster optimism, though potential interstitial lung disease concerns could prompt labeling adjustments or rare delays. No recent setbacks have emerged to erode sentiment.
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.
Обсяг
$769Дата завершення
May 18, 2026Ринок відкрито
Apr 29, 2026, 8:06 PM ETResolver
0x65070BE91...Trader consensus prices "Yes" at 79% implied probability for FDA approval of Daiichi Sankyo and AstraZeneca's Enhertu supplemental biologics license application, driven by compelling DESTINY-Breast05 Phase III data showing a 53% reduction in invasive disease-free survival risk versus standard T-DM1 in post-neoadjuvant HER2-positive early breast cancer patients with residual disease. The FDA's Priority Review designation on March 9, 2026—following Breakthrough Therapy status in December 2025—has fast-tracked review, with PDUFA target action date of May 18, just days away. Enhertu's established safety profile and prior metastatic breast cancer approvals bolster optimism, though potential interstitial lung disease concerns could prompt labeling adjustments or rare delays. No recent setbacks have emerged to erode sentiment.
Експериментальне резюме, згенероване ШІ з посиланням на дані Polymarket. Це не торгова порада і не впливає на вирішення цього ринку. · Оновлено
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