Trader consensus on Polymarket prices a 68.5% implied probability for FDA approval of Grace Therapeutics' GTx-104, an intravenous nimodipine formulation for aneurysmal subarachnoid hemorrhage (aSAH), driven by robust Phase 3 STRIVE-ON trial data meeting its primary safety endpoint with a 19% reduction in clinically significant hypotension versus oral nimodipine, alongside superior secondary outcomes in dose intensity, 90-day functional recovery, and reduced ICU utilization. Four days ago, Grace announced acceptance of a STRIVE-ON abstract for presentation at AAN 2026, reinforcing clinical benefits without drug-related safety signals despite a non-significant mortality imbalance. With the PDUFA target date just five days away on April 23, 2026, and orphan drug designation providing market exclusivity, traders weigh standard review risks against the lack of innovation in aSAH treatment for decades.
Polymarket verilerine atıfta bulunan deneysel AI tarafından oluşturulmuş özet. Bu bir işlem tavsiyesi değildir ve bu piyasanın nasıl çözümlendiğinde hiçbir rolü yoktur. · GüncellendiYENİ
YENİ
23 Nis 2026
YENİ
YENİ
23 Nis 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 prices a 68.5% implied probability for FDA approval of Grace Therapeutics' GTx-104, an intravenous nimodipine formulation for aneurysmal subarachnoid hemorrhage (aSAH), driven by robust Phase 3 STRIVE-ON trial data meeting its primary safety endpoint with a 19% reduction in clinically significant hypotension versus oral nimodipine, alongside superior secondary outcomes in dose intensity, 90-day functional recovery, and reduced ICU utilization. Four days ago, Grace announced acceptance of a STRIVE-ON abstract for presentation at AAN 2026, reinforcing clinical benefits without drug-related safety signals despite a non-significant mortality imbalance. With the PDUFA target date just five days away on April 23, 2026, and orphan drug designation providing market exclusivity, traders weigh standard review risks against the lack of innovation in aSAH treatment for decades.
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.
Piyasa Açıldı: Apr 16, 2026, 8:45 PM ET
Hacim
$855Bitiş Tarihi
23 Nis 2026Piyasa Açıldı
Apr 16, 2026, 8:45 PM ETResolver
0x65070BE91...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 prices a 68.5% implied probability for FDA approval of Grace Therapeutics' GTx-104, an intravenous nimodipine formulation for aneurysmal subarachnoid hemorrhage (aSAH), driven by robust Phase 3 STRIVE-ON trial data meeting its primary safety endpoint with a 19% reduction in clinically significant hypotension versus oral nimodipine, alongside superior secondary outcomes in dose intensity, 90-day functional recovery, and reduced ICU utilization. Four days ago, Grace announced acceptance of a STRIVE-ON abstract for presentation at AAN 2026, reinforcing clinical benefits without drug-related safety signals despite a non-significant mortality imbalance. With the PDUFA target date just five days away on April 23, 2026, and orphan drug designation providing market exclusivity, traders weigh standard review risks against the lack of innovation in aSAH treatment for decades.
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.
Hacim
$855Bitiş Tarihi
23 Nis 2026Piyasa Açıldı
Apr 16, 2026, 8:45 PM ETResolver
0x65070BE91...Trader consensus on Polymarket prices a 68.5% implied probability for FDA approval of Grace Therapeutics' GTx-104, an intravenous nimodipine formulation for aneurysmal subarachnoid hemorrhage (aSAH), driven by robust Phase 3 STRIVE-ON trial data meeting its primary safety endpoint with a 19% reduction in clinically significant hypotension versus oral nimodipine, alongside superior secondary outcomes in dose intensity, 90-day functional recovery, and reduced ICU utilization. Four days ago, Grace announced acceptance of a STRIVE-ON abstract for presentation at AAN 2026, reinforcing clinical benefits without drug-related safety signals despite a non-significant mortality imbalance. With the PDUFA target date just five days away on April 23, 2026, and orphan drug designation providing market exclusivity, traders weigh standard review risks against the lack of innovation in aSAH treatment for decades.
Polymarket verilerine atıfta bulunan deneysel AI tarafından oluşturulmuş özet. Bu bir işlem tavsiyesi değildir ve bu piyasanın nasıl çözümlendiğinde hiçbir rolü yoktur. · Güncellendi
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