Odyssey Therapeutics (ODTX) FDA Approvals $19.18 -1.66 (-7.97%) As of 10:30 AM 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. 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 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 6, 2026, involving OD-001. The update was categorized as "Results," with the company reporting: "Odyssey 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." 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 BridgeBio Pharma FDA EventsBluejay Diagnostics FDA EventsOdyssey Therapeutics FDA EventsPDS Biotechnology FDA EventsQuoin Pharmaceuticals FDA EventsSCYNEXIS FDA EventsStoke Therapeutics FDA EventsViking Therapeutics FDA EventsAlterity Therapeutics FDA EventsHeartBeam FDA EventsBenitec Biopharma FDA EventsCapricor Therapeutics FDA EventsCrescent Biopharma FDA EventsEstablishment Labs FDA EventsGuardant Health 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 Tango Therapeutics FDA Events Viking Therapeutics FDA Events Veracyte FDA Events Xenon Pharmaceuticals FDA Events Legend Biotech FDA Events Celcuity FDA Events CareDx FDA Events ACADIA Pharmaceuticals FDA Events IDEAYA Biosciences FDA Events Denali Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:ODTX last updated on 10/6/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersA weekly dividend fund holding Nvidia and PalantirCrowdStrike, Palantir, Nvidia none of them pay a real dividend. But one fund holding the biggest AI names dist...Investors Alley | SponsoredDo this before December or regret itPorter Stansberry believes President Trump will use the December G20 Summit in Miami to unveil a radical monet...Porter & Company | SponsoredTicker Revealed: Pre-IPO Access to "Next Elon Musk" CompanyWe’ve found The Next Elon Musk… and what we believe to be the next Tesla. It’s already racked up $26 billi...Banyan Hill Publishing | SponsoredElon Musk’s One Stock Retirement PlanStanley Druckenmiller once said you don't get rich diversifying into 50 mediocre assets - you get rich finding...Brownstone Research | SponsoredThe case for $20,000 gold before year endPresident Trump reposted a warning from precious metals expert Jim Rickards, tying the November midterms and A...Stansberry Research | SponsoredMan who Predicted Trump 2016 Win: “Prepare for Mid-Term Meltdown”In 2016, major election models gave Hillary Clinton a 99% chance of winning - but former CIA and Pentagon advi...Paradigm Press | SponsoredLouis Navellier: My #1 AI stock for 2026 (name & ticker inside)Louis Navellier's Stock Grader system helped him flag Nvidia before its 82,000% run and has identified the top...InvestorPlace | SponsoredAnthropic’s $40 million midterm moveAnthropic, creator of Claude, has committed $40 million to Public First Action, a nonpartisan group advocating...The Oxford Club | Sponsored Adding Choose a watchlist: Watchlist Adding You have already added ten stocks to your watchlist. Upgrade to MarketBeat All Access to add more stocks to your watchlist. Adding Odyssey Therapeutics, Inc. Please log in to your account or sign up in order to add this asset to your watchlist. Share Odyssey Therapeutics With A Colleague Link copied to clipboard. Unlock superior investment research and tools. Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools and reports. Get MarketBeat All Access MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In Email Me a Login Link or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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
