FDA approval of AstraZeneca’s Truqap (capivasertib) plus abiraterone and androgen deprivation therapy for PTEN-deficient metastatic hormone-sensitive prostate cancer remains unlikely after the May 14, 2026 resolution deadline passed without a decision. The supplemental New Drug Application, accepted in August 2025 and supported by positive CAPItello-281 Phase III data presented at ESMO 2025, received a favorable 7-1 ODAC vote on April 30. However, pre-meeting FDA briefing documents highlighted the trial’s modest radiographic progression-free survival benefit, immature overall survival results, and substantially higher rates of serious adverse events, fueling persistent safety concerns in an earlier-line setting. Traders view the lack of action by the market close as decisive evidence that the FDA is unlikely to grant approval on the current timeline, underscoring how regulatory caution can override advisory committee recommendations when benefit-risk questions persist.
Experimentelle KI-generierte Zusammenfassung mit Polymarket-Daten. Dies ist keine Handelsberatung und spielt keine Rolle bei der Auflösung dieses Marktes. · AktualisiertJa
$5,063 Vol.
$5,063 Vol.
30. Apr. 2026
Ja
$5,063 Vol.
$5,063 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.FDA approval of AstraZeneca’s Truqap (capivasertib) plus abiraterone and androgen deprivation therapy for PTEN-deficient metastatic hormone-sensitive prostate cancer remains unlikely after the May 14, 2026 resolution deadline passed without a decision. The supplemental New Drug Application, accepted in August 2025 and supported by positive CAPItello-281 Phase III data presented at ESMO 2025, received a favorable 7-1 ODAC vote on April 30. However, pre-meeting FDA briefing documents highlighted the trial’s modest radiographic progression-free survival benefit, immature overall survival results, and substantially higher rates of serious adverse events, fueling persistent safety concerns in an earlier-line setting. Traders view the lack of action by the market close as decisive evidence that the FDA is unlikely to grant approval on the current timeline, underscoring how regulatory caution can override advisory committee recommendations when benefit-risk questions persist.
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.
Markt eröffnet: Apr 20, 2026, 5:45 PM ET
Volumen
$5,063Enddatum
30. Apr. 2026Markt eröffnet
Apr 20, 2026, 5:45 PM ETResolver
0x65070BE91...Vorgeschlagenes Ergebnis: Nein
Kein Einspruch
Endgültiges Ergebnis: Nein
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.FDA approval of AstraZeneca’s Truqap (capivasertib) plus abiraterone and androgen deprivation therapy for PTEN-deficient metastatic hormone-sensitive prostate cancer remains unlikely after the May 14, 2026 resolution deadline passed without a decision. The supplemental New Drug Application, accepted in August 2025 and supported by positive CAPItello-281 Phase III data presented at ESMO 2025, received a favorable 7-1 ODAC vote on April 30. However, pre-meeting FDA briefing documents highlighted the trial’s modest radiographic progression-free survival benefit, immature overall survival results, and substantially higher rates of serious adverse events, fueling persistent safety concerns in an earlier-line setting. Traders view the lack of action by the market close as decisive evidence that the FDA is unlikely to grant approval on the current timeline, underscoring how regulatory caution can override advisory committee recommendations when benefit-risk questions persist.
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.
Volumen
$5,063Enddatum
30. Apr. 2026Markt eröffnet
Apr 20, 2026, 5:45 PM ETResolver
0x65070BE91...Vorgeschlagenes Ergebnis: Nein
Kein Einspruch
Endgültiges Ergebnis: Nein
FDA approval of AstraZeneca’s Truqap (capivasertib) plus abiraterone and androgen deprivation therapy for PTEN-deficient metastatic hormone-sensitive prostate cancer remains unlikely after the May 14, 2026 resolution deadline passed without a decision. The supplemental New Drug Application, accepted in August 2025 and supported by positive CAPItello-281 Phase III data presented at ESMO 2025, received a favorable 7-1 ODAC vote on April 30. However, pre-meeting FDA briefing documents highlighted the trial’s modest radiographic progression-free survival benefit, immature overall survival results, and substantially higher rates of serious adverse events, fueling persistent safety concerns in an earlier-line setting. Traders view the lack of action by the market close as decisive evidence that the FDA is unlikely to grant approval on the current timeline, underscoring how regulatory caution can override advisory committee recommendations when benefit-risk questions persist.
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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