Portage Biotech's Drug in the FDA Approval Process
This 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.
- Drug:
- TT-4
- Announced Date:
- November 12, 2025
- Indication:
- in mesothelioma
Announcement
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.
AI Summary
AlphaTON 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
As of now, Portage Biotech (ALP) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Portage Biotech (ALP) has reported FDA regulatory activity for TT-4.
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."
Currently, Portage Biotech has one therapy (TT-4) targeting the following condition: in mesothelioma.
More FDA Event Resources from MarketBeat
Companies With Recent 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
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.
Free ALP Stock Alerts