Trader consensus on Polymarket reflects near-certainty at 96.9% for "No" on FDA approval of AstraZeneca's camizestrant, driven primarily by the Oncologic Drugs Advisory Committee's (ODAC) 6-3 vote against its risk-benefit profile on the April 30, 2026 PDUFA target date. The panel cited concerns over the SERENA-6 trial's single-arm design and limited evidence of clinical benefit for switching to the next-generation oral selective estrogen receptor degrader (SERD) upon ESR1 mutation detection in HR-positive, HER2-negative advanced breast cancer. With no approval announced two weeks past the deadline despite AstraZeneca's ongoing FDA discussions, traders anticipate rejection or significant delays. Realistic shifts could occur if the FDA overrides ODAC—as in about 30% of cases—or new data emerges, though trial design flaws and regulatory scrutiny make approval unlikely.
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$2,832 KL.
$2,832 KL.
Apr 30, 2026
$2,832 KL.
$2,832 KL.
Apr 30, 2026
As of market creation, the FDA's expected decision date for the specified application is April 30, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for AstraZeneca's Camizestrant as a treatment for HR+/HER2- advanced or metastatic breast cancer with ESR1 mutation by May 14, 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 Polymarket reflects near-certainty at 96.9% for "No" on FDA approval of AstraZeneca's camizestrant, driven primarily by the Oncologic Drugs Advisory Committee's (ODAC) 6-3 vote against its risk-benefit profile on the April 30, 2026 PDUFA target date. The panel cited concerns over the SERENA-6 trial's single-arm design and limited evidence of clinical benefit for switching to the next-generation oral selective estrogen receptor degrader (SERD) upon ESR1 mutation detection in HR-positive, HER2-negative advanced breast cancer. With no approval announced two weeks past the deadline despite AstraZeneca's ongoing FDA discussions, traders anticipate rejection or significant delays. Realistic shifts could occur if the FDA overrides ODAC—as in about 30% of cases—or new data emerges, though trial design flaws and regulatory scrutiny make approval unlikely.
As of market creation, the FDA's expected decision date for the specified application is April 30, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for AstraZeneca's Camizestrant as a treatment for HR+/HER2- advanced or metastatic breast cancer with ESR1 mutation by May 14, 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 AstraZeneca's Camizestrant as a treatment for HR+/HER2- advanced or metastatic breast cancer with ESR1 mutation by May 14, 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 20, 2026, 5:44 PM ET
Khối lượng
$2,832Ngày kết thúc
Apr 30, 2026Thị trường mở
Apr 20, 2026, 5:44 PM ETResolver
0x65070BE91...As of market creation, the FDA's expected decision date for the specified application is April 30, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for AstraZeneca's Camizestrant as a treatment for HR+/HER2- advanced or metastatic breast cancer with ESR1 mutation by May 14, 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 Polymarket reflects near-certainty at 96.9% for "No" on FDA approval of AstraZeneca's camizestrant, driven primarily by the Oncologic Drugs Advisory Committee's (ODAC) 6-3 vote against its risk-benefit profile on the April 30, 2026 PDUFA target date. The panel cited concerns over the SERENA-6 trial's single-arm design and limited evidence of clinical benefit for switching to the next-generation oral selective estrogen receptor degrader (SERD) upon ESR1 mutation detection in HR-positive, HER2-negative advanced breast cancer. With no approval announced two weeks past the deadline despite AstraZeneca's ongoing FDA discussions, traders anticipate rejection or significant delays. Realistic shifts could occur if the FDA overrides ODAC—as in about 30% of cases—or new data emerges, though trial design flaws and regulatory scrutiny make approval unlikely.
As of market creation, the FDA's expected decision date for the specified application is April 30, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for AstraZeneca's Camizestrant as a treatment for HR+/HER2- advanced or metastatic breast cancer with ESR1 mutation by May 14, 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 AstraZeneca's Camizestrant as a treatment for HR+/HER2- advanced or metastatic breast cancer with ESR1 mutation by May 14, 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
$2,832Ngày kết thúc
Apr 30, 2026Thị trường mở
Apr 20, 2026, 5:44 PM ETResolver
0x65070BE91...Trader consensus on Polymarket reflects near-certainty at 96.9% for "No" on FDA approval of AstraZeneca's camizestrant, driven primarily by the Oncologic Drugs Advisory Committee's (ODAC) 6-3 vote against its risk-benefit profile on the April 30, 2026 PDUFA target date. The panel cited concerns over the SERENA-6 trial's single-arm design and limited evidence of clinical benefit for switching to the next-generation oral selective estrogen receptor degrader (SERD) upon ESR1 mutation detection in HR-positive, HER2-negative advanced breast cancer. With no approval announced two weeks past the deadline despite AstraZeneca's ongoing FDA discussions, traders anticipate rejection or significant delays. Realistic shifts could occur if the FDA overrides ODAC—as in about 30% of cases—or new data emerges, though trial design flaws and regulatory scrutiny make approval unlikely.
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
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