Trader consensus on Polymarket reflects 100% implied probability against FDA approval of Grace Therapeutics' GTx-104, an intravenous nimodipine formulation for aneurysmal subarachnoid hemorrhage (aSAH), driven by the agency's Complete Response Letter (CRL) issued today on the April 23 PDUFA target date. The CRL cites deficiencies in chemistry, manufacturing, and controls (CMC)—including leachables from packaging, nonclinical toxicology assessments, and contract manufacturing issues—without requesting new clinical data. This definitive roadblock, common in biotech NDAs, precludes approval until resubmission, fueling unassailable "No" positioning amid real capital at stake. While Grace plans a Type A meeting for clarification, historical CRL-to-approval timelines exceed the May 7 market resolution, barring an unprecedented rapid fix; regulatory intervention or withdrawal would cement "No."
Résumé expérimental généré par IA à partir des données Polymarket. Ceci n'est pas un conseil de trading et ne joue aucun rôle dans la résolution de ce marché. · Mis à jourFDA approves Grace Therapeutics’ GTx-104?
FDA approves Grace Therapeutics’ GTx-104?
$4,959 Vol.
$4,959 Vol.
23 avr. 2026
$4,959 Vol.
$4,959 Vol.
23 avr. 2026
As of market creation, the FDA’s expected decision date for the specified application is April 23, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Grace Therapeutics’ GTx-104 as a treatment for aneurysmal subarachnoid hemorrhage by May 7, 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 100% implied probability against FDA approval of Grace Therapeutics' GTx-104, an intravenous nimodipine formulation for aneurysmal subarachnoid hemorrhage (aSAH), driven by the agency's Complete Response Letter (CRL) issued today on the April 23 PDUFA target date. The CRL cites deficiencies in chemistry, manufacturing, and controls (CMC)—including leachables from packaging, nonclinical toxicology assessments, and contract manufacturing issues—without requesting new clinical data. This definitive roadblock, common in biotech NDAs, precludes approval until resubmission, fueling unassailable "No" positioning amid real capital at stake. While Grace plans a Type A meeting for clarification, historical CRL-to-approval timelines exceed the May 7 market resolution, barring an unprecedented rapid fix; regulatory intervention or withdrawal would cement "No."
As of market creation, the FDA’s expected decision date for the specified application is April 23, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Grace Therapeutics’ GTx-104 as a treatment for aneurysmal subarachnoid hemorrhage by May 7, 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 Grace Therapeutics’ GTx-104 as a treatment for aneurysmal subarachnoid hemorrhage by May 7, 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.
Marché ouvert : Apr 16, 2026, 8:45 PM ET
Volume
$4,959Date de fin
23 avr. 2026Marché ouvert
Apr 16, 2026, 8:45 PM ETResolver
0x65070BE91...Résultat proposé: No
Aucune contestation
Résultat final: No
As of market creation, the FDA’s expected decision date for the specified application is April 23, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Grace Therapeutics’ GTx-104 as a treatment for aneurysmal subarachnoid hemorrhage by May 7, 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 100% implied probability against FDA approval of Grace Therapeutics' GTx-104, an intravenous nimodipine formulation for aneurysmal subarachnoid hemorrhage (aSAH), driven by the agency's Complete Response Letter (CRL) issued today on the April 23 PDUFA target date. The CRL cites deficiencies in chemistry, manufacturing, and controls (CMC)—including leachables from packaging, nonclinical toxicology assessments, and contract manufacturing issues—without requesting new clinical data. This definitive roadblock, common in biotech NDAs, precludes approval until resubmission, fueling unassailable "No" positioning amid real capital at stake. While Grace plans a Type A meeting for clarification, historical CRL-to-approval timelines exceed the May 7 market resolution, barring an unprecedented rapid fix; regulatory intervention or withdrawal would cement "No."
As of market creation, the FDA’s expected decision date for the specified application is April 23, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Grace Therapeutics’ GTx-104 as a treatment for aneurysmal subarachnoid hemorrhage by May 7, 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 Grace Therapeutics’ GTx-104 as a treatment for aneurysmal subarachnoid hemorrhage by May 7, 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
$4,959Date de fin
23 avr. 2026Marché ouvert
Apr 16, 2026, 8:45 PM ETResolver
0x65070BE91...Résultat proposé: No
Aucune contestation
Résultat final: No
Trader consensus on Polymarket reflects 100% implied probability against FDA approval of Grace Therapeutics' GTx-104, an intravenous nimodipine formulation for aneurysmal subarachnoid hemorrhage (aSAH), driven by the agency's Complete Response Letter (CRL) issued today on the April 23 PDUFA target date. The CRL cites deficiencies in chemistry, manufacturing, and controls (CMC)—including leachables from packaging, nonclinical toxicology assessments, and contract manufacturing issues—without requesting new clinical data. This definitive roadblock, common in biotech NDAs, precludes approval until resubmission, fueling unassailable "No" positioning amid real capital at stake. While Grace plans a Type A meeting for clarification, historical CRL-to-approval timelines exceed the May 7 market resolution, barring an unprecedented rapid fix; regulatory intervention or withdrawal would cement "No."
Résumé expérimental généré par IA à partir des données Polymarket. Ceci n'est pas un conseil de trading et ne joue aucun rôle dans la résolution de ce marché. · Mis à jour
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