Trader consensus prices "Yes" at 78.5% implied probability for FDA approval of Daiichi Sankyo and AstraZeneca's Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate (ADC), driven by compelling Phase III DESTINY-Breast11 data showing over 67% pathological complete response (pCR) rates in high-risk HER2-positive early breast cancer neoadjuvant setting versus 56% for control. This follows Breakthrough Therapy Designation and Priority Review, building on Enhertu's track record of multiple U.S. approvals, including December 2025 first-line metastatic combination. The PDUFA target action date looms on May 18—just days away—fueling optimism despite interstitial lung disease risks, with a separate post-neoadjuvant sBLA PDUFA set for July 7. No major updates in the past week, but proximity to resolution anchors current positioning.
Experimentelle KI-generierte Zusammenfassung mit Polymarket-Daten. Dies ist keine Handelsberatung und spielt keine Rolle bei der Auflösung dieses Marktes. · AktualisiertFDA genehmigt Enhertu von Daiichi Sankyo & AstraZeneca?
FDA genehmigt Enhertu von Daiichi Sankyo & AstraZeneca?
Ja
NEU
NEU
18. Mai 2026
Ja
NEU
NEU
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 prices "Yes" at 78.5% implied probability for FDA approval of Daiichi Sankyo and AstraZeneca's Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate (ADC), driven by compelling Phase III DESTINY-Breast11 data showing over 67% pathological complete response (pCR) rates in high-risk HER2-positive early breast cancer neoadjuvant setting versus 56% for control. This follows Breakthrough Therapy Designation and Priority Review, building on Enhertu's track record of multiple U.S. approvals, including December 2025 first-line metastatic combination. The PDUFA target action date looms on May 18—just days away—fueling optimism despite interstitial lung disease risks, with a separate post-neoadjuvant sBLA PDUFA set for July 7. No major updates in the past week, but proximity to resolution anchors current positioning.
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.
Markt eröffnet: Apr 29, 2026, 8:06 PM ET
Volumen
$862Enddatum
18. Mai 2026Markt eröffnet
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 78.5% implied probability for FDA approval of Daiichi Sankyo and AstraZeneca's Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate (ADC), driven by compelling Phase III DESTINY-Breast11 data showing over 67% pathological complete response (pCR) rates in high-risk HER2-positive early breast cancer neoadjuvant setting versus 56% for control. This follows Breakthrough Therapy Designation and Priority Review, building on Enhertu's track record of multiple U.S. approvals, including December 2025 first-line metastatic combination. The PDUFA target action date looms on May 18—just days away—fueling optimism despite interstitial lung disease risks, with a separate post-neoadjuvant sBLA PDUFA set for July 7. No major updates in the past week, but proximity to resolution anchors current positioning.
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.
Volumen
$862Enddatum
18. Mai 2026Markt eröffnet
Apr 29, 2026, 8:06 PM ETResolver
0x65070BE91...Trader consensus prices "Yes" at 78.5% implied probability for FDA approval of Daiichi Sankyo and AstraZeneca's Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate (ADC), driven by compelling Phase III DESTINY-Breast11 data showing over 67% pathological complete response (pCR) rates in high-risk HER2-positive early breast cancer neoadjuvant setting versus 56% for control. This follows Breakthrough Therapy Designation and Priority Review, building on Enhertu's track record of multiple U.S. approvals, including December 2025 first-line metastatic combination. The PDUFA target action date looms on May 18—just days away—fueling optimism despite interstitial lung disease risks, with a separate post-neoadjuvant sBLA PDUFA set for July 7. No major updates in the past week, but proximity to resolution anchors current positioning.
Experimentelle KI-generierte Zusammenfassung mit Polymarket-Daten. Dies ist keine Handelsberatung und spielt keine Rolle bei der Auflösung dieses Marktes. · Aktualisiert
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