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icon for FDA approves Celcuity's Gedatolisib?
Tech·Medicine

FDA approves Celcuity's Gedatolisib?

icon for FDA approves Celcuity's Gedatolisib?
Tech·Medicine

FDA approves Celcuity's Gedatolisib?

juin 19

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juil. 11

juil. 17

juin 19

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juil. 17

68% chance
Polymarket
NOUVEAU
68% chance
Polymarket
NOUVEAU
As of market creation, the FDA's expected decision date for the specified application is July 17, 2026. This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Celcuity's Gedatolisib as a treatment for HR+/HER2-, PIK3CA wild-type advanced breast cancer by July 31, 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.

As of market creation, the FDA's expected decision date for the specified application is July 17, 2026.

This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Celcuity's Gedatolisib as a treatment for HR+/HER2-, PIK3CA wild-type advanced breast cancer by July 31, 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
$0
Date de fin
17 juil. 2026
Marché ouvert
Jul 1, 2026, 1:42 AM ET

Resolver

0x65070BE91...
As of market creation, the FDA's expected decision date for the specified application is July 17, 2026. This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Celcuity's Gedatolisib as a treatment for HR+/HER2-, PIK3CA wild-type advanced breast cancer by July 31, 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.
As of market creation, the FDA's expected decision date for the specified application is July 17, 2026. This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Celcuity's Gedatolisib as a treatment for HR+/HER2-, PIK3CA wild-type advanced breast cancer by July 31, 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.

As of market creation, the FDA's expected decision date for the specified application is July 17, 2026.

This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Celcuity's Gedatolisib as a treatment for HR+/HER2-, PIK3CA wild-type advanced breast cancer by July 31, 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
$0
Date de fin
17 juil. 2026
Marché ouvert
Jul 1, 2026, 1:42 AM ET

Resolver

0x65070BE91...
As of market creation, the FDA's expected decision date for the specified application is July 17, 2026. This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Celcuity's Gedatolisib as a treatment for HR+/HER2-, PIK3CA wild-type advanced breast cancer by July 31, 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.

Méfiez-vous des liens externes.

Questions fréquentes

« FDA approves Celcuity's Gedatolisib? » est un marché de prédiction sur Polymarket où les traders achètent et vendent des parts « Oui » ou « Non » selon qu'ils estiment que cet événement se produira ou non. La probabilité actuelle selon la communauté est de 68% pour « Yes ». Par exemple, si « Oui » est coté à 68¢, le marché attribue collectivement une probabilité de 68% que cet événement se produise. Ces cotes changent en permanence à mesure que les traders réagissent aux nouveaux développements et informations. Les parts du résultat correct sont échangeables contre $1 chacune lors de la résolution du marché.

« FDA approves Celcuity's Gedatolisib? » est un marché nouvellement créé sur Polymarket, lancé le Jul 1, 2026. En tant que marché récent, c'est votre opportunité d'être parmi les premiers traders à définir les cotes et établir les premiers signaux de prix du marché. Vous pouvez également ajouter cette page à vos favoris pour suivre le volume et l'activité de trading au fil du temps.

Pour trader sur « FDA approves Celcuity's Gedatolisib? », choisissez simplement si vous pensez que la réponse est « Oui » ou « Non ». Chaque côté a un prix actuel qui reflète la probabilité implicite du marché. Entrez votre montant et cliquez sur « Trader ». Si vous achetez des parts « Oui » et que le résultat se résout comme « Oui », chaque part rapporte $1. S'il se résout comme « Non », vos parts « Oui » rapportent $0. Vous pouvez également vendre vos parts à tout moment avant la résolution pour sécuriser un gain ou limiter une perte.

La probabilité actuelle pour « FDA approves Celcuity's Gedatolisib? » est de 68% pour « Yes ». Cela signifie que la communauté Polymarket estime actuellement qu'il y a une probabilité de 68% que cet événement se produise. Ces cotes sont mises à jour en temps réel sur la base de transactions réelles, fournissant un signal continuellement actualisé de ce que le marché attend.

Les règles de résolution de « FDA approves Celcuity's Gedatolisib? » définissent exactement ce qui doit se produire pour que chaque résultat soit déclaré gagnant, y compris les sources de données officielles utilisées pour déterminer le résultat. Vous pouvez consulter les critères de résolution complets dans la section « Règles » sur cette page au-dessus des commentaires. Nous recommandons de lire attentivement les règles avant de trader, car elles précisent les conditions exactes, les cas particuliers et les sources.