Odyssey Therapeutics (ODTX) FDA Approvals $17.24 -1.02 (-5.59%) As of 10/13/2026 04:00 PM Eastern Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsInsider TradesNews and TrendsOwnershipSEC FilingsShort Interest Odyssey Therapeutics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Odyssey Therapeutics (ODTX). Over the past two years, Odyssey Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as OD-001. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. OD-001 FDA Regulatory Events OD-001 is a drug developed by Odyssey Therapeutics for the following indication: in Ulcerative Colitis. 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. Provided Update - October 12,2026Provided Update Drug: OD-001Announced Date: October 12, 2026Indication: in Ulcerative ColitisAnnouncementOdyssey Therapeutics, Inc. announced that it will present the design of a randomized, double-blind Phase 2a trial evaluating OD-001 in combination with vedolizumab in patients with moderate-to-severe ulcerative colitis (UC) at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting, taking place October 9-14, in Nashville, Tennessee.Read AnnouncementResults - October 6,2026Results Phase 2aDrug: OD-001Announced Date: October 6, 2026Indication: in Ulcerative ColitisAnnouncementOdyssey Therapeutics, Inc. announced that additional results from the OD-001 induction period of its Phase 2a trial in moderate to severe ulcerative colitis will be featured in an oral presentation at United European Gastroenterology (UEG) Week 2026, taking place October 17-20, in Barcelona, Spain.Read Announcement Odyssey Therapeutics FDA Events - Frequently Asked Questions Has Odyssey Therapeutics received FDA approval? As of now, Odyssey Therapeutics (ODTX) has not received any FDA approvals for its therapy in the last two years. What drugs has Odyssey Therapeutics submitted to the FDA? In the past two years, Odyssey Therapeutics (ODTX) has reported FDA regulatory activity for OD-001. What is the most recent FDA event for Odyssey Therapeutics? The most recent FDA-related event for Odyssey Therapeutics occurred on October 12, 2026, involving OD-001. The update was categorized as "Provided Update," with the company reporting: "Odyssey Therapeutics, Inc. announced that it will present the design of a randomized, double-blind Phase 2a trial evaluating OD-001 in combination with vedolizumab in patients with moderate-to-severe ulcerative colitis (UC) at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting, taking place October 9-14, in Nashville, Tennessee." What conditions do Odyssey Therapeutics' current drugs treat? Currently, Odyssey Therapeutics has one therapy (OD-001) targeting the following condition: in Ulcerative Colitis. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events AgomAb Therapeutics FDA EventsAlkermes FDA EventsBeam Therapeutics FDA EventsBiomea Fusion FDA EventsBioNTech FDA EventsEnanta Pharmaceuticals FDA EventsEntera Bio FDA EventsImmuron FDA EventsKura Oncology FDA EventsEthos Technologies Inc. Class A Common Stock FDA EventsModerna FDA EventsPhio Pharmaceuticals FDA EventsPrelude Therapeutics FDA EventsRhythm Pharmaceuticals FDA EventsSAB Biotherapeutics 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 Veracyte FDA Events Legend Biotech FDA Events Viking Therapeutics FDA Events Xenon Pharmaceuticals FDA Events ACADIA Pharmaceuticals FDA Events Celcuity FDA Events IDEAYA Biosciences FDA Events Amylyx Pharmaceuticals FDA Events Denali Therapeutics FDA Events Arcus Biosciences FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:ODTX last updated on 10/12/2026 by MarketBeat.com Staff. 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Provided Update - October 12,2026Provided Update Drug: OD-001Announced Date: October 12, 2026Indication: in Ulcerative ColitisAnnouncementOdyssey Therapeutics, Inc. announced that it will present the design of a randomized, double-blind Phase 2a trial evaluating OD-001 in combination with vedolizumab in patients with moderate-to-severe ulcerative colitis (UC) at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting, taking place October 9-14, in Nashville, Tennessee.Read Announcement
Results - October 6,2026Results Phase 2aDrug: OD-001Announced Date: October 6, 2026Indication: in Ulcerative ColitisAnnouncementOdyssey Therapeutics, Inc. announced that additional results from the OD-001 induction period of its Phase 2a trial in moderate to severe ulcerative colitis will be featured in an oral presentation at United European Gastroenterology (UEG) Week 2026, taking place October 17-20, in Barcelona, Spain.Read Announcement
