Optimi Health (OPTH) FDA Approvals $2.25 +0.07 (+3.21%) As of 11/13/2026 04:00 PM Eastern Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsFDA EventsNews and TrendsSEC Filings Upcoming FDA Events for Optimi Health Optimi Health (OPTH) has upcoming FDA regulatory milestones for psilocybin-assisted therapy. The table below outlines estimated target dates and event types for these pending regulatory actions. DrugTarget DateAnnouncement psilocybin-assisted therapyH1 2027Trial InitiationOptimi Health Corp announced that the trial is planned to be initiated in the first half of 2027 (September 10, 2026) psilocybin-assisted therapyLATE 2027Dose UpdateOptimi Health Corp. announced that the dosing expected to be complete by the end of 2027. (September 10, 2026) Optimi Health's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Optimi Health (OPTH). Over the past two years, Optimi Health has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as psilocybin-assisted. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Psilocybin-assisted therapy FDA Regulatory Timeline and Events Psilocybin-assisted therapy is a drug developed by Optimi Health for the following indication: for Major Depressive Disorder. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Trial Initiation - September 10,2026Trial Initiation Drug: psilocybin-assisted therapyAnnounced Date: September 10, 2026Target Action Date: H1 2027Estimated Target Date Range: January 1, 2027 - June 30, 2027Indication: for Major Depressive DisorderAnnouncementOptimi Health Corp announced that the trial is planned to be initiated in the first half of 2027Read AnnouncementDose Update - September 10,2026Dose Update Drug: psilocybin-assisted therapyAnnounced Date: September 10, 2026Target Action Date: LATE 2027Estimated Target Date Range: October 1, 2027 - December 31, 2027Indication: for Major Depressive DisorderAnnouncementOptimi Health Corp. announced that the dosing expected to be complete by the end of 2027.Read AnnouncementTrial Initiation - September 10,2026Trial Initiation Phase 2Drug: psilocybin-assisted therapyAnnounced Date: September 10, 2026Indication: for Major Depressive DisorderAnnouncementOptimi Health Corp announces plans to initiate a multisite Phase 2 clinical trial evaluating psilocybin-assisted therapy for individuals with major depressive disorder ("MDD").Read Announcement Optimi Health FDA Events - Frequently Asked Questions Has Optimi Health received FDA approval? As of now, Optimi Health (OPTH) has not received any FDA approvals for its therapy in the last two years. What drugs has Optimi Health submitted to the FDA? In the past two years, Optimi Health (OPTH) has reported FDA regulatory activity for psilocybin-assisted therapy. What is the most recent FDA event for Optimi Health? The most recent FDA-related event for Optimi Health occurred on September 10, 2026, involving psilocybin-assisted therapy. The update was categorized as "Trial Initiation," with the company reporting: "Optimi Health Corp announced that the trial is planned to be initiated in the first half of 2027" What conditions do Optimi Health's current drugs treat? Currently, Optimi Health has one therapy (psilocybin-assisted therapy) targeting the following condition: for Major Depressive Disorder. 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FDA EventsAltimmune FDA EventsPlus Therapeutics FDA EventsAlpha Tau Medical FDA EventsImmuneering FDA EventsMetaVia FDA EventsNeonc Technologies FDA EventsTraws Pharma FDA EventsTakeda Pharmaceutical FDA EventsBridgeBio Pharma FDA EventsCoherus Oncology FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Dogwood Therapeutics FDA Events Alterity Therapeutics FDA Events Aldeyra Therapeutics FDA Events Veru FDA Events Athira Pharma FDA Events Aardvark Therapeutics FDA Events SCYNEXIS FDA Events Eyepoint Pharmaceuticals FDA Events Polyrizon FDA Events MIRA Pharmaceuticals FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:OPTH last updated on 9/10/2026 by MarketBeat.com Staff. 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Trial Initiation - September 10,2026Trial Initiation Drug: psilocybin-assisted therapyAnnounced Date: September 10, 2026Target Action Date: H1 2027Estimated Target Date Range: January 1, 2027 - June 30, 2027Indication: for Major Depressive DisorderAnnouncementOptimi Health Corp announced that the trial is planned to be initiated in the first half of 2027Read Announcement
Dose Update - September 10,2026Dose Update Drug: psilocybin-assisted therapyAnnounced Date: September 10, 2026Target Action Date: LATE 2027Estimated Target Date Range: October 1, 2027 - December 31, 2027Indication: for Major Depressive DisorderAnnouncementOptimi Health Corp. announced that the dosing expected to be complete by the end of 2027.Read Announcement
Trial Initiation - September 10,2026Trial Initiation Phase 2Drug: psilocybin-assisted therapyAnnounced Date: September 10, 2026Indication: for Major Depressive DisorderAnnouncementOptimi Health Corp announces plans to initiate a multisite Phase 2 clinical trial evaluating psilocybin-assisted therapy for individuals with major depressive disorder ("MDD").Read Announcement
