Trader consensus on Polymarket reflects a 94.4% implied probability against FDA approval of AstraZeneca's Truqap (capivasertib) sNDA for PTEN-deficient metastatic hormone-sensitive prostate cancer by the April 30, 2026, resolution deadline, driven primarily by the absence of a written approval announcement on or before that date despite a favorable 7-1 ODAC vote on the same day affirming the benefit-risk profile from the CAPItello-281 trial. Pre-meeting FDA briefing documents highlighted concerns over the AKT inhibitor's poor toxicity profile—serious adverse events nearly doubled to 42.5%—versus modest radiographic progression-free survival gains (HR 0.81) and immature overall survival data (HR 0.90). Realistic challenges include an ultra-rare same-day approval or market resolution ambiguity, though FDA typically requires post-ODAC review time, solidifying the strong No positioning amid oncology regulatory caution.
Riepilogo sperimentale generato dall'AI con riferimento ai dati di Polymarket. Questo non è un consiglio di trading e non ha alcun ruolo nella risoluzione di questo mercato. · AggiornatoLa FDA approva Truqap (capivasertib) di AstraZeneca?
La FDA approva Truqap (capivasertib) di AstraZeneca?
Sì
$3,248 Vol.
$3,248 Vol.
30 apr 2026
Sì
$3,248 Vol.
$3,248 Vol.
30 apr 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 Truqap (capivasertib) as a treatment for metastatic hormone-sensitive prostate cancer (PTEN-deficient) 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 a 94.4% implied probability against FDA approval of AstraZeneca's Truqap (capivasertib) sNDA for PTEN-deficient metastatic hormone-sensitive prostate cancer by the April 30, 2026, resolution deadline, driven primarily by the absence of a written approval announcement on or before that date despite a favorable 7-1 ODAC vote on the same day affirming the benefit-risk profile from the CAPItello-281 trial. Pre-meeting FDA briefing documents highlighted concerns over the AKT inhibitor's poor toxicity profile—serious adverse events nearly doubled to 42.5%—versus modest radiographic progression-free survival gains (HR 0.81) and immature overall survival data (HR 0.90). Realistic challenges include an ultra-rare same-day approval or market resolution ambiguity, though FDA typically requires post-ODAC review time, solidifying the strong No positioning amid oncology regulatory caution.
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 Truqap (capivasertib) as a treatment for metastatic hormone-sensitive prostate cancer (PTEN-deficient) 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 Truqap (capivasertib) as a treatment for metastatic hormone-sensitive prostate cancer (PTEN-deficient) 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.
Mercato aperto: Apr 20, 2026, 5:45 PM ET
Volume
$3,248Data di fine
30 apr 2026Mercato aperto
Apr 20, 2026, 5:45 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 Truqap (capivasertib) as a treatment for metastatic hormone-sensitive prostate cancer (PTEN-deficient) 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 a 94.4% implied probability against FDA approval of AstraZeneca's Truqap (capivasertib) sNDA for PTEN-deficient metastatic hormone-sensitive prostate cancer by the April 30, 2026, resolution deadline, driven primarily by the absence of a written approval announcement on or before that date despite a favorable 7-1 ODAC vote on the same day affirming the benefit-risk profile from the CAPItello-281 trial. Pre-meeting FDA briefing documents highlighted concerns over the AKT inhibitor's poor toxicity profile—serious adverse events nearly doubled to 42.5%—versus modest radiographic progression-free survival gains (HR 0.81) and immature overall survival data (HR 0.90). Realistic challenges include an ultra-rare same-day approval or market resolution ambiguity, though FDA typically requires post-ODAC review time, solidifying the strong No positioning amid oncology regulatory caution.
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 Truqap (capivasertib) as a treatment for metastatic hormone-sensitive prostate cancer (PTEN-deficient) 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 Truqap (capivasertib) as a treatment for metastatic hormone-sensitive prostate cancer (PTEN-deficient) 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.
Volume
$3,248Data di fine
30 apr 2026Mercato aperto
Apr 20, 2026, 5:45 PM ETResolver
0x65070BE91...Trader consensus on Polymarket reflects a 94.4% implied probability against FDA approval of AstraZeneca's Truqap (capivasertib) sNDA for PTEN-deficient metastatic hormone-sensitive prostate cancer by the April 30, 2026, resolution deadline, driven primarily by the absence of a written approval announcement on or before that date despite a favorable 7-1 ODAC vote on the same day affirming the benefit-risk profile from the CAPItello-281 trial. Pre-meeting FDA briefing documents highlighted concerns over the AKT inhibitor's poor toxicity profile—serious adverse events nearly doubled to 42.5%—versus modest radiographic progression-free survival gains (HR 0.81) and immature overall survival data (HR 0.90). Realistic challenges include an ultra-rare same-day approval or market resolution ambiguity, though FDA typically requires post-ODAC review time, solidifying the strong No positioning amid oncology regulatory caution.
Riepilogo sperimentale generato dall'AI con riferimento ai dati di Polymarket. Questo non è un consiglio di trading e non ha alcun ruolo nella risoluzione di questo mercato. · Aggiornato
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