Trader consensus prices "No" at 81.5% for FDA approval of any psychedelic for medical use in 2026, reflecting regulatory caution following the agency's 2024 rejection of Lykos Therapeutics' MDMA-assisted therapy for PTSD due to insufficient Phase 3 safety data. Despite Compass Pathways' positive Phase 3 results in February 2026 for COMP360 psilocybin in treatment-resistant depression—backed by prior breakthrough therapy designation—the FDA blocked fast-track review that month amid Trump administration reluctance to accelerate psychedelics. Standard new drug application review timelines of 10-12 months make end-2026 approval unlikely, even as Compass plans FDA meetings for a rolling submission; state expansions like Connecticut's pilot program signal anticipation but hinge on federal action.
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 a psychedelic for medical use in 2026?
FDA approves a psychedelic for medical use in 2026?
Psychedelic substances include: LSD, Psilocybin, DMT, Mescaline, MDMA, MDA, PCP, DXM, Ibogaine, Salvia divinorum, 2C family, and Ayahuasca.
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
If the listed drug is approved within this market’s timeframe, 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, 10:42 AM ET
Resolver
0x65070BE91...Psychedelic substances include: LSD, Psilocybin, DMT, Mescaline, MDMA, MDA, PCP, DXM, Ibogaine, Salvia divinorum, 2C family, and Ayahuasca.
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
If the listed drug is approved within this market’s timeframe, 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.
Resolver
0x65070BE91...Trader consensus prices "No" at 81.5% for FDA approval of any psychedelic for medical use in 2026, reflecting regulatory caution following the agency's 2024 rejection of Lykos Therapeutics' MDMA-assisted therapy for PTSD due to insufficient Phase 3 safety data. Despite Compass Pathways' positive Phase 3 results in February 2026 for COMP360 psilocybin in treatment-resistant depression—backed by prior breakthrough therapy designation—the FDA blocked fast-track review that month amid Trump administration reluctance to accelerate psychedelics. Standard new drug application review timelines of 10-12 months make end-2026 approval unlikely, even as Compass plans FDA meetings for a rolling submission; state expansions like Connecticut's pilot program signal anticipation but hinge on federal action.
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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