Portage Biotech (ALP) FDA Approvals $0.20 -0.01 (-2.55%) As of 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 Abeona Therapeutics FDA EventsAltimmune FDA EventsAtossa Genetics FDA EventsAtea Pharmaceuticals FDA EventsCorbus Pharmaceuticals FDA EventsDyne Therapeutics FDA EventsGalmed Pharmaceuticals FDA EventsNovogen FDA EventsLantern Pharma FDA EventsPlus Therapeutics FDA EventsRedhill Biopharma FDA EventsArrowhead Pharmaceuticals FDA EventsCAMP4 Therapeutics FDA EventsEikon Therapeutics FDA EventsIDEAYA Biosciences 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 VYNE Therapeutics FDA Events Polyrizon FDA Events BioXcel Therapeutics FDA Events Tvardi Therapeutics FDA Events Celularity FDA Events Novogen FDA Events NeuroSense Therapeutics FDA Events Medicus Pharma 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:ALP last updated on 11/12/2025 by MarketBeat.com Staff. 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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
