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Tecnologia·Science

FDA approves UX111?

icon for FDA approves UX111?
Tecnologia·Science

FDA approves UX111?

Ended: ago 18, 2025

mag 29

mag 31

Ended: ago 18, 2025

mag 29

mag 31

<1% probabilità
Polymarket

$41,440 Vol.

<1% probabilità
Polymarket

$41,440 Vol.

This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Ultragenyx Pharmaceutical Inc.'s and Abeona Therapeutics' UX111 (also known as ABO-102), an AAV gene therapy for the treatment of Sanfilippo syndrome type A (MPS IIIA), by August 31, 2025, 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 month, the market will resolve to "No" immediately. If the listed drug is approved before the end of the month, 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 Ultragenyx Pharmaceutical Inc.'s and Abeona Therapeutics' UX111 (also known as ABO-102), an AAV gene therapy for the treatment of Sanfilippo syndrome type A (MPS IIIA), by August 31, 2025, 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 month, the market will resolve to "No" immediately.

If the listed drug is approved before the end of the month, 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
$41,440
Data di fine
18 ago 2025
Mercato aperto
Jul 29, 2025, 11:28 AM ET

Resolver

0x157Ce2d67...
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Ultragenyx Pharmaceutical Inc.'s and Abeona Therapeutics' UX111 (also known as ABO-102), an AAV gene therapy for the treatment of Sanfilippo syndrome type A (MPS IIIA), by August 31, 2025, 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 month, the market will resolve to "No" immediately. If the listed drug is approved before the end of the month, 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.

Esito proposto: No

Nessuna contestazione

Esito finale: No

This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Ultragenyx Pharmaceutical Inc.'s and Abeona Therapeutics' UX111 (also known as ABO-102), an AAV gene therapy for the treatment of Sanfilippo syndrome type A (MPS IIIA), by August 31, 2025, 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 month, the market will resolve to "No" immediately. If the listed drug is approved before the end of the month, 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 Ultragenyx Pharmaceutical Inc.'s and Abeona Therapeutics' UX111 (also known as ABO-102), an AAV gene therapy for the treatment of Sanfilippo syndrome type A (MPS IIIA), by August 31, 2025, 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 month, the market will resolve to "No" immediately.

If the listed drug is approved before the end of the month, 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
$41,440
Data di fine
18 ago 2025
Mercato aperto
Jul 29, 2025, 11:28 AM ET

Resolver

0x157Ce2d67...
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Ultragenyx Pharmaceutical Inc.'s and Abeona Therapeutics' UX111 (also known as ABO-102), an AAV gene therapy for the treatment of Sanfilippo syndrome type A (MPS IIIA), by August 31, 2025, 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 month, the market will resolve to "No" immediately. If the listed drug is approved before the end of the month, 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.

Esito proposto: No

Nessuna contestazione

Esito finale: No

Fai attenzione ai link esterni.

Domande frequenti

"FDA approves UX111?" è un mercato predittivo su Polymarket dove i trader comprano e vendono azioni "Sì" o "No" in base a se credono che questo evento accadrà. La probabilità attuale aggregata è 0% per "Yes". Ad esempio, se "Sì" è quotato a 0¢, il mercato assegna collettivamente una probabilità di 0% che questo evento si verifichi. Queste quote cambiano continuamente man mano che i trader reagiscono a nuovi sviluppi e informazioni. Le azioni nell'esito corretto possono essere riscattate per $1 ciascuna alla risoluzione del mercato.

Ad oggi, "FDA approves UX111?" ha generato $41.4K in volume totale di trading dal lancio del mercato il Jul 29, 2025. Questo livello di attività di trading riflette un forte coinvolgimento della comunità Polymarket e contribuisce a garantire che le quote attuali siano informate da un ampio pool di partecipanti al mercato. Puoi seguire i movimenti di prezzo in tempo reale e fare trading su qualsiasi esito direttamente su questa pagina.

Per fare trading su "FDA approves UX111?", scegli semplicemente se ritieni che la risposta sia "Sì" o "No". Ogni lato ha un prezzo corrente che riflette la probabilità implicita del mercato. Inserisci il tuo importo e clicca "Trading". Se compri azioni "Sì" e l'esito si risolve come "Sì", ogni azione paga $1. Se si risolve come "No", le tue azioni "Sì" pagano $0. Puoi anche vendere le tue azioni in qualsiasi momento prima della risoluzione se vuoi consolidare un profitto o limitare una perdita.

La probabilità attuale per "FDA approves UX111?" è 0% per "Yes". Questo significa che la comunità Polymarket attualmente ritiene che ci sia una probabilità di 0% che questo evento si verifichi. Queste quote si aggiornano in tempo reale basandosi sulle operazioni effettive, fornendo un segnale continuamente aggiornato di ciò che il mercato si aspetta accada.

Le regole di risoluzione per "FDA approves UX111?" definiscono esattamente cosa deve accadere affinché ogni esito venga dichiarato vincitore — comprese le fonti di dati ufficiali utilizzate per determinare il risultato. Puoi consultare i criteri completi di risoluzione nella sezione "Regole" di questa pagina sopra i commenti. Ti consigliamo di leggere attentamente le regole prima di fare trading, poiché specificano le condizioni precise, i casi limite e le fonti che regolano come viene risolto questo mercato.