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icon for La FDA approuve le Ctx-1301 de Cingulate ?

La FDA approuve le Ctx-1301 de Cingulate ?

icon for La FDA approuve le Ctx-1301 de Cingulate ?

La FDA approuve le Ctx-1301 de Cingulate ?

Oui

<1% chance
Polymarket

$10,950 Vol.

Oui

<1% chance
Polymarket

$10,950 Vol.

As of market creation, the FDA's expected decision date for the specified application is May 31, 2026. This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Cingulate's Ctx-1301 as a treatment for children and adults with attention-deficit/hyperactivity disorder (ADHD) by June 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.Cingulate received a Complete Response Letter from the FDA shortly after the May 31, 2026 PDUFA target date for its CTx-1301 NDA under the 505(b)(2) pathway, signaling that the application in its current form was not approved due to unresolved manufacturing, chemistry, or controls issues. Traders have priced this outcome at near-certainty because the agency action directly followed the review timeline, consistent with standard regulatory practice when additional data or responses are required. While the company continues engaging the FDA and maintains cash runway into 2027 for potential resubmission, approval remains contingent on addressing the CRL specifics, with no guaranteed timeline or outcome.

As of market creation, the FDA's expected decision date for the specified application is May 31, 2026.

This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Cingulate's Ctx-1301 as a treatment for children and adults with attention-deficit/hyperactivity disorder (ADHD) by June 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
$10,950
Date de fin
31 mai 2026
Marché ouvert
May 20, 2026, 3:46 PM ET
As of market creation, the FDA's expected decision date for the specified application is May 31, 2026. This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Cingulate's Ctx-1301 as a treatment for children and adults with attention-deficit/hyperactivity disorder (ADHD) by June 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.

Résultat proposé: Non

Aucune contestation

Résultat final: Non

As of market creation, the FDA's expected decision date for the specified application is May 31, 2026. This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Cingulate's Ctx-1301 as a treatment for children and adults with attention-deficit/hyperactivity disorder (ADHD) by June 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.Cingulate received a Complete Response Letter from the FDA shortly after the May 31, 2026 PDUFA target date for its CTx-1301 NDA under the 505(b)(2) pathway, signaling that the application in its current form was not approved due to unresolved manufacturing, chemistry, or controls issues. Traders have priced this outcome at near-certainty because the agency action directly followed the review timeline, consistent with standard regulatory practice when additional data or responses are required. While the company continues engaging the FDA and maintains cash runway into 2027 for potential resubmission, approval remains contingent on addressing the CRL specifics, with no guaranteed timeline or outcome.

As of market creation, the FDA's expected decision date for the specified application is May 31, 2026.

This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Cingulate's Ctx-1301 as a treatment for children and adults with attention-deficit/hyperactivity disorder (ADHD) by June 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
$10,950
Date de fin
31 mai 2026
Marché ouvert
May 20, 2026, 3:46 PM ET
As of market creation, the FDA's expected decision date for the specified application is May 31, 2026. This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Cingulate's Ctx-1301 as a treatment for children and adults with attention-deficit/hyperactivity disorder (ADHD) by June 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.

Résultat proposé: Non

Aucune contestation

Résultat final: Non

Méfiez-vous des liens externes.

Questions fréquentes

« La FDA approuve le Ctx-1301 de Cingulate ? » est un marché de prédiction sur Polymarket avec 2 résultats possibles où les traders achètent et vendent des parts selon ce qu'ils pensent qu'il se passera. Le résultat en tête actuel est « La FDA approuve le Ctx-1301 de Cingulate ? » à 0%. Les prix reflètent des probabilités en temps réel de la communauté. Par exemple, une part cotée à 0¢ implique que le marché attribue collectivement une probabilité de 0% à ce résultat. Ces cotes changent en permanence. Les parts du résultat correct sont échangeables contre $1 chacune lors de la résolution du marché.

À ce jour, « La FDA approuve le Ctx-1301 de Cingulate ? » a généré $11K en volume total de trading depuis le lancement du marché le May 20, 2026. Ce niveau d'activité reflète un fort engagement de la communauté Polymarket et garantit que les cotes actuelles sont alimentées par un large bassin de participants. Vous pouvez suivre les mouvements de prix en direct et trader sur n'importe quel résultat directement sur cette page.

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