Portage Biotech (ATON) FDA Approvals $0.33 +0.01 (+3.75%) Closing price 04/20/2026Extended Trading$0.33 0.00 (0.00%) As of 04/20/2026 07:59 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesSEC FilingsTrendsBuy This Stock Portage Biotech's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Portage Biotech (ATON). Over the past two years, Portage Biotech has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as TT-4. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. TT-4 FDA Regulatory Events TT-4 is a drug developed by Portage Biotech for the following indication: in mesothelioma. 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 - November 12,2025Provided Update Drug: TT-4Announced Date: November 12, 2025Indication: in mesotheliomaAnnouncementAlphaTON Capital Corp announced a non-binding Letter of Intent (LOI) between Australia's Asbestos and Dust Diseases Research Institute (ADDRI) and Tarus Therapeutics, LLC to conduct an investigator-initiated clinical trial evaluating TT-4, Cyncado's selective A2B receptor antagonist, in mesothelioma.AI SummaryAlphaTON Capital’s oncology unit, Cyncado Therapeutics, announced a non-binding letter of intent with Australia’s Asbestos and Dust Diseases Research Institute (ADDRI) to run an investigator-initiated trial of TT-4, Cyncado’s selective A2B receptor antagonist, in mesothelioma. The Australian trial is planned to enroll about 50 patients and would run alongside Cyncado’s planned U.S. activities. Cyncado has agreed to provide TT-4 and limited support, subject to a definitive agreement and customary approvals. The study aims to address the urgent need for effective options after first-line therapy, since there is no widely accepted second-line standard and outcomes remain poor. The trial builds on preclinical data supporting TT-4’s use in mesothelioma. It will be led by A/Prof Steven Kao (Chris O’Brien Lifehouse/ADDRI) and Dr. Melvin Chin (Sir Charles Gairdner Hospital/NCARD), with Australia seen as a compelling setting due to its high mesothelioma burden.Read Announcement Portage Biotech FDA Events - Frequently Asked Questions Has Portage Biotech received FDA approval? As of now, Portage Biotech (ATON) has not received any FDA approvals for its therapy in the last two years. What drugs has Portage Biotech submitted to the FDA? In the past two years, Portage Biotech (ATON) has reported FDA regulatory activity for TT-4. What is the most recent FDA event for Portage Biotech? The most recent FDA-related event for Portage Biotech occurred on November 12, 2025, involving TT-4. The update was categorized as "Provided Update," with the company reporting: "AlphaTON Capital Corp announced a non-binding Letter of Intent (LOI) between Australia's Asbestos and Dust Diseases Research Institute (ADDRI) and Tarus Therapeutics, LLC to conduct an investigator-initiated clinical trial evaluating TT-4, Cyncado's selective A2B receptor antagonist, in mesothelioma." What conditions do Portage Biotech's current drugs treat? Currently, Portage Biotech has one therapy (TT-4) targeting the following condition: in mesothelioma. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Belite Bio FDA EventsINmune Bio FDA EventsKymera Therapeutics FDA EventsLigand Pharmaceuticals FDA EventsProtara Therapeutics FDA EventsTenaya Therapeutics FDA EventsUrogen Pharma FDA EventsAardvark Therapeutics FDA EventsAgenus FDA EventsApyx Medical FDA EventsAtossa Genetics FDA EventsBiogen FDA EventsBioLineRx FDA EventsCAMP4 Therapeutics FDA EventsCelcuity 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 Briacell Therap FDA Events Tevogen Bio FDA Events NeuroSense Therapeutics FDA Events Neuphoria Therapeutics FDA Events Tempest Therapeutics FDA Events ABVC BioPharma FDA Events Celularity FDA Events Polyrizon FDA Events Jasper Therapeutics FDA Events Marker Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:ATON last updated on 11/12/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersSpaceX eyes a 1.75 trillion valuation - here's what to knowElon Musk's team has quietly filed confidential paperwork with the SEC for what Bloomberg estimates could be a...Brownstone Research | SponsoredIran's New Leader Just Said Something That Should Terrify Every AmericanIran's Supreme Leader has declared the Strait of Hormuz closed as leverage against the U.S. - and with 40% of ...American Alternative | Sponsored$30 stock to buy before Starlink goes public (WATCH NOW!)In the next 3 minutes… James Altucher – legendary investor and venture capitalist… And someone who’s kno...Paradigm Press | SponsoredYour book attachedYour Download Link (Expiring) If you still haven't downloaded the free Simple Options Trading For Beginners...Profits Run | SponsoredMy feud with Zohran MamdaniEmmy-winning analyst releases his next big story Whitney Tilson shocked the nation on 60 Minutes when he ac...Stansberry Research | SponsoredIran War Shock: What I Was Told In That Private MeetingYou’re Being LIED To About The Iran War Forget EVERYTHING you’ve heard about the Iran war. Especially th...Banyan Hill Publishing | SponsoredTrump's gold order: the announcement they won't put on the front pageOn August 15, 1971, Nixon interrupted prime-time television and ended the gold standard in 15 minutes - no deb...Reagan Gold Group | SponsoredWhy this tiny stock may move before the SpaceX IPO dropsThe projected SpaceX and xAI S-1 filing hits the SEC on June 1st - and analyst Dylan Jovine says $1.75 trillio...Behind the Markets | 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 Portage Biotech Inc. Please log in to your account or sign up in order to add this asset to your watchlist. Share Portage Biotech With A Colleague Link copied to clipboard. Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. Start Your 30-Day Trial 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.
Provided Update - November 12,2025Provided Update Drug: TT-4Announced Date: November 12, 2025Indication: in mesotheliomaAnnouncementAlphaTON Capital Corp announced a non-binding Letter of Intent (LOI) between Australia's Asbestos and Dust Diseases Research Institute (ADDRI) and Tarus Therapeutics, LLC to conduct an investigator-initiated clinical trial evaluating TT-4, Cyncado's selective A2B receptor antagonist, in mesothelioma.AI SummaryAlphaTON Capital’s oncology unit, Cyncado Therapeutics, announced a non-binding letter of intent with Australia’s Asbestos and Dust Diseases Research Institute (ADDRI) to run an investigator-initiated trial of TT-4, Cyncado’s selective A2B receptor antagonist, in mesothelioma. The Australian trial is planned to enroll about 50 patients and would run alongside Cyncado’s planned U.S. activities. Cyncado has agreed to provide TT-4 and limited support, subject to a definitive agreement and customary approvals. The study aims to address the urgent need for effective options after first-line therapy, since there is no widely accepted second-line standard and outcomes remain poor. The trial builds on preclinical data supporting TT-4’s use in mesothelioma. It will be led by A/Prof Steven Kao (Chris O’Brien Lifehouse/ADDRI) and Dr. Melvin Chin (Sir Charles Gairdner Hospital/NCARD), with Australia seen as a compelling setting due to its high mesothelioma burden.Read Announcement
Free ATON Stock Alerts