Trader consensus on Polymarket heavily favors "No" at 96.9% for FDA approval of AstraZeneca's camizestrant, a next-generation oral selective estrogen receptor degrader (SERD) targeting ESR1-mutated, hormone receptor-positive, HER2-negative advanced breast cancer, driven primarily by the Oncologic Drugs Advisory Committee's (ODAC) 6-3 vote against its clinical benefit on April 30, 2026. The panel questioned the SERENA-6 Phase III trial's strategy of early ctDNA-guided switching from first-line endocrine therapy plus CDK4/6 inhibitors, citing insufficient evidence of meaningful progression-free survival advantage over standard care. While FDA is not bound by ODAC recommendations, it historically aligns in ~80% of oncology cases, fueling this strong skepticism amid no new supportive data. Realistic shifts could stem from FDA overriding the vote with fresh analyses or supplemental filings, though additional trials would likely be required, potentially delaying any path forward by months or years.
Экспериментальная сводка, созданная ИИ на основе данных Polymarket. Это не является торговой рекомендацией и не влияет на то, как разрешается этот рынок. · ОбновленоFDA одобряет камизестрант AstraZeneca?
FDA одобряет камизестрант AstraZeneca?
Да
$2,832 Объем
$2,832 Объем
30 апр. 2026 г.
Да
$2,832 Объем
$2,832 Объем
30 апр. 2026 г.
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 heavily favors "No" at 96.9% for FDA approval of AstraZeneca's camizestrant, a next-generation oral selective estrogen receptor degrader (SERD) targeting ESR1-mutated, hormone receptor-positive, HER2-negative advanced breast cancer, driven primarily by the Oncologic Drugs Advisory Committee's (ODAC) 6-3 vote against its clinical benefit on April 30, 2026. The panel questioned the SERENA-6 Phase III trial's strategy of early ctDNA-guided switching from first-line endocrine therapy plus CDK4/6 inhibitors, citing insufficient evidence of meaningful progression-free survival advantage over standard care. While FDA is not bound by ODAC recommendations, it historically aligns in ~80% of oncology cases, fueling this strong skepticism amid no new supportive data. Realistic shifts could stem from FDA overriding the vote with fresh analyses or supplemental filings, though additional trials would likely be required, potentially delaying any path forward by months or years.
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.
Открытие рынка: Apr 20, 2026, 5:44 PM ET
Объем
$2,832Дата окончания
30 апр. 2026 г.Открытие рынка
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 heavily favors "No" at 96.9% for FDA approval of AstraZeneca's camizestrant, a next-generation oral selective estrogen receptor degrader (SERD) targeting ESR1-mutated, hormone receptor-positive, HER2-negative advanced breast cancer, driven primarily by the Oncologic Drugs Advisory Committee's (ODAC) 6-3 vote against its clinical benefit on April 30, 2026. The panel questioned the SERENA-6 Phase III trial's strategy of early ctDNA-guided switching from first-line endocrine therapy plus CDK4/6 inhibitors, citing insufficient evidence of meaningful progression-free survival advantage over standard care. While FDA is not bound by ODAC recommendations, it historically aligns in ~80% of oncology cases, fueling this strong skepticism amid no new supportive data. Realistic shifts could stem from FDA overriding the vote with fresh analyses or supplemental filings, though additional trials would likely be required, potentially delaying any path forward by months or years.
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.
Объем
$2,832Дата окончания
30 апр. 2026 г.Открытие рынка
Apr 20, 2026, 5:44 PM ETResolver
0x65070BE91...Trader consensus on Polymarket heavily favors "No" at 96.9% for FDA approval of AstraZeneca's camizestrant, a next-generation oral selective estrogen receptor degrader (SERD) targeting ESR1-mutated, hormone receptor-positive, HER2-negative advanced breast cancer, driven primarily by the Oncologic Drugs Advisory Committee's (ODAC) 6-3 vote against its clinical benefit on April 30, 2026. The panel questioned the SERENA-6 Phase III trial's strategy of early ctDNA-guided switching from first-line endocrine therapy plus CDK4/6 inhibitors, citing insufficient evidence of meaningful progression-free survival advantage over standard care. While FDA is not bound by ODAC recommendations, it historically aligns in ~80% of oncology cases, fueling this strong skepticism amid no new supportive data. Realistic shifts could stem from FDA overriding the vote with fresh analyses or supplemental filings, though additional trials would likely be required, potentially delaying any path forward by months or years.
Экспериментальная сводка, созданная ИИ на основе данных Polymarket. Это не является торговой рекомендацией и не влияет на то, как разрешается этот рынок. · Обновлено
Не доверяй внешним ссылкам.
Не доверяй внешним ссылкам.
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