Portage Biotech (ALP) FDA Approvals $0.16 -0.01 (-8.48%) As of 08/17/2026 04:00 PM Eastern 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 (ALP). 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 (ALP) 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 (ALP) 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 BeOne Medicines FDA EventsAmylyx Pharmaceuticals FDA Eventsargenex FDA EventsEyepoint Pharmaceuticals FDA EventsRadiopharm Theranostics FDA EventsUrogen Pharma FDA EventsUnited Therapeutics FDA EventsPfizer FDA EventsHUTCHMED FDA EventsMesoblast FDA EventsFate Therapeutics FDA EventsLantheus FDA EventsAgenus FDA EventsBiomea Fusion FDA EventsMiNK Therapeutics 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 Mainz Biomed FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:ALP last updated on 11/12/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersThey didn't warn anyone in 1971. This time someone is warning you.On August 15, 1971, Nixon interrupted prime-time television and ended the gold standard in 15 minutes - no deb...Reagan Gold Group | SponsoredIran War: What Happened at 1:11 P.M. Outside D.C.?A source with ties to Saudi Arabia, the UAE, and the U.S. State Department revealed details of a potential 7 t...Banyan Hill Publishing | SponsoredTrump’s New Currency ResetTrump is launching a new $250 bill - but that may be a distraction. Behind the scenes, Executive Order 14241 i...Porter & Company | SponsoredThe trade I’ve been waiting for since 2011Ross Givens, Director of Research at Traders Agency, is calling for gold to reach $10,000 an ounce this superc...Traders Agency | SponsoredA Wall Street veteran shares two simple trading rulesA self-described Market Wizard says two simple rules, refined over decades on Wall Street, form the basis of h...Brownstone Research | Sponsored19 Factories. One AI Brain. One Hidden Stock.A little-known aerospace manufacturer has linked 19 factories worldwide into a single AI-ready data system, dr...The Oxford Club | SponsoredSomeone just dumped the biggest gold fund.Investors pulled 2.9 billion dollars from the world's largest gold fund in a single day this March, pushing to...Behind the Markets | SponsoredA Dark Day Is Coming to AmericaKeith Kaplan, CEO of TradeSmith, has spent more than $17 million studying AI since 2022. He says a major shift...TradeSmith | 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. 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.
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
