piclidenoson (CF101) / Can-Fite, Gebro, Cipher, China Medical System, Ewopharma, Kyongbo Pharmaceutical - LARVOL DELTA

SW/PSYCH: CF 101 for New Pediatric Psychosocial Clinicians (NACFC 2026) - No abstract available

Clinical • Pediatrics

SW/PSYCH: CF 101 for New Adult Psychosocial Clinicians (NACFC 2026) - No abstract available

Clinical

Clinical Progress in Psoriasis (GlobeNewswire) - "The Company completed enrolment of the first 247 patients in its pivotal Phase 3 study evaluating Piclidenoson for the treatment of moderate-to-severe plaque psoriasis. The study has now reached the pre-specified interim analysis stage under a protocol agreed with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The interim analysis will evaluate efficacy and safety data from the enrolled patients. Results are expected during Q1 2027."

P3 data • Trial status • Plaque Psoriasis • Psoriasis

CF101. Behind the Drapes: Thoracic and Airway Crises Unfold (1 CME) (ASA 2026) - "SessionLearningObjective1: Explain the pathophysiological mechanisms underlying tracheal injuries (e.g., cuff overinflation, tube malposition) and vascular injuries (e.g., inadvertent vessel laceration, altered anatomy).SessionLearningObjective2: Identify the challenges and evaluate effective strategies for lung isolation in tracheostomized patients, including the use of bronchial blockers, double-lumen tubes, and modified endotracheal tubes.SessionLearningObjective3: Describe how the location, size, and characteristics of a mediastinal mass can affect critical structures such as the trachea, bronchi, heart, and great vessels. Discuss the pathophysiology of airway compression, superior vena cava syndrome, andSessionLearningObjective4: Discuss the pathophysiology of airway compression, superior vena cava syndrome, and cardiovascular collapse associated with mediastinal masses."

Cardiovascular

Piclidenoson, Can-Fite’s oral A3AR agonist for inflammatory diseases, is currently being evaluated in a Phase III clinical program for the treatment of moderate-to-severe plaque psoriasis. (The Manila Times) - "Can-Fite’s clinical development strategy is focused on advancing its lead drug candidates through late-stage clinical development under regulatory pathways established with leading regulatory authorities."

Trial status • Immunology • Plaque Psoriasis

Can-Fite BioPharma…announced the submission of a Phase 2 clinical study protocol to Bambino Gesù Children's Hospital in Rome, Italy, for the first clinical evaluation of Piclidenoson in patients with Lowe syndrome, a rare inherited genetic disorder with no approved disease-modifying therapies (GlobeNewswire) - "The Phase 2 study is an open-label, single-center clinical trial designed to evaluate the efficacy and safety of oral Piclidenoson administered twice daily for six months in 5 adult patients with genetically confirmed Lowe syndrome."

New P2 trial • Genetic Disorders • Rare Diseases

Adenosine Receptor 3 Antagonism Suppresses Adipogenesis via the EREG-EGFR-Leptin Axis in Multipotent Cells. (PubMed, Biofactors) - "Transcriptomic profiling and pathway analysis performed in C3H10T1/2 cells suggested that the Ereg gene, which encodes epiregulin (EREG), is a potential target of MRS1220 mediated adipogenesis inhibition...In contrast, the AR3 agonist CF101 enhanced adipogenesis independent of the EREG-EGFR-leptin axis. These findings establish AR3 as a key regulator of adipogenic differentiation and uncover an AR3-EREG-EGFR-leptin signaling cascade as a mechanism by which AR3 antagonism inhibits adipogenesis. Targeting AR3 may offer a novel strategy to modulate adipose tissue formation in metabolic diseases."

Journal • Metabolic Disorders • EGFR • EREG • LEP • PPARG

Can-Fite BioPharma…announced completion of enrolment of the first 247 patients in its pivotal Phase 3 study evaluating Piclidenoson for the treatment of moderate-to-severe plaque psoriasis (GlobeNewswire) - "The study has now reached the pre-specified interim analysis stage under a protocol agreed with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The interim analysis will evaluate efficacy and safety data from the enrolled patients. Results are expected during Q4 2026/Q1 2027....The study is a randomized, double-blind, placebo-controlled Phase 3 trial aimed at demonstrating clinical safety and efficacy for the treatment of patients with moderate to severe plaque psoriasis."

Enrollment closed • P3 data • Psoriasis

Can-Fite Achieves Key Pivotal Phase 3 Psoriasis Milestone with Completion of Patient Enrolment for the Interim Analysis: Data Expected Q4 2026/Q1 2027 (GlobeNewswire) - "The study is a randomized, double-blind, placebo-controlled Phase 3 trial aimed at demonstrating clinical safety and efficacy for the treatment of patients with moderate to severe plaque psoriasis. Patients are treated with 3 mg Piclidenoson tablets or placebo administered orally twice daily."

P3 data • Trial status • Immunology • Psoriasis

A3 Adenosine Receptor Agonists as Multisystem Disease Modifiers: From Molecular Signaling to Clinical Translation. (PubMed, Biomolecules) - "Importantly, these mechanistic insights have been translated into clinical programs, with piclidenoson and namodenoson demonstrating favorable safety profiles and disease-modifying activity in inflammatory, fibrotic, and oncologic indications. This review integrates molecular, cellular, and translational evidence to highlight A3AR activation as a unifying therapeutic principle for diseases driven by inflammation, oxidative stress, hypoxia, and dysregulated cell survival, positioning selective A3AR agonists as first-in-class agents targeting the A3AR, with broad clinical applicability across multiple disease domains."

Journal • Review • Cardiovascular • CNS Disorders • Dermatology • Fibrosis • Hepatocellular Cancer • Hepatology • Immunology • Ischemic stroke • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Oncology • Ophthalmology • Osteoarthritis • Pain • Pancreatic Cancer • Psoriasis • Rheumatoid Arthritis • Rheumatology • Solid Tumor • CTNNB1

Piclidenoson, an A3 adenosine receptor agonist, demonstrates clinical benefit in canine osteoarthritis: a pilot study. (PubMed, Front Vet Sci) - "No serious adverse events deemed possibly- or probably-related to the study drug were reported. Piclidenoson was well tolerated, and the findings suggest potential efficacy, thus supporting its further evaluation as a treatment for canine osteoarthritis."

Clinical • Journal • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

A Phase 3 Study in Moderate-to-Severe Plaque Psoriasis With Piclidenoson to Study Safety and Efficacy (clinicaltrials.gov) - P3 | N=705 | Not yet recruiting | Sponsor: Can-Fite BioPharma | N=313 ➔ 705

Enrollment change • Dermatology • Immunology • Psoriasis

An Open-label, Phase 2 Pilot Study on the Efficacy and Safety of Piclidenoson in Patients With Lowe Syndrome (clinicaltrials.gov) - P2 | N=5 | Not yet recruiting | Sponsor: Can-Fite BioPharma

New P2 trial • B2M

Piclidenoson drug candidate (GlobeNewswire) - "Can-Fite is currently enrolling patients in a pivotal Phase III clinical study for the treatment of psoriasis...Based on the Company’s current assumptions, interim analysis data is expected to be released in the second quarter of 2026. The Company also completed the development of a Phase II study protocol for the rare genetic disease Lowe Syndrome and plans to submit it to regulatory authorities in Italy and EMA during Q1 2026."

Clinical protocol • Filing • P3 data • Genetic Disorders • Psoriasis

Can-Fite’s Latest Developments of its Advanced Stage Drug Pipeline will be Presented at Noble Capital Markets 21st Annual Emerging Growth Equity Conference (GlobeNewswire) - "Mr. Farbstein will present the latest developments in Can-Fite’s advanced stage drug development pipeline including the following trials: Phase III liver cancer; Phase IIa pancreatic cancer; Phase III psoriasis; Phase IIb MASH..."

Trial status • Liver Cancer • Metabolic Dysfunction-Associated Steatohepatitis • Pancreatic Cancer • Psoriasis

CF 101 for New Pediatric Psychosocial Clinicians (NACFC 2025) - No abstract available

Clinical • Pediatrics

CF 101 for New Adult Psychosocial Clinicians (NACFC 2025) - No abstract available

Clinical

Can-Fite Reports H1 2025 Financial Results… (GlobeNewswire) - "Research and development expenses for the first half of 2025 comprised primarily of expenses associated with the ongoing of the Phase 3 study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase 3 study in the treatment of advanced liver cancer and a Phase 2b study for MASH."

Commercial • Hepatocellular Cancer • Metabolic Dysfunction-Associated Steatohepatitis • Psoriasis

Local anti-inflammatory effect in a psoriasis model using a photoswitchable drug, A3 adenosine receptor agonist MRS7787 (ACS-Fall 2025) - "The agonist structure was designed based on the experimental anti-inflammatory drug Piclidenoson (IB-MECA, Phase 3 for psoriasis)...As a result, our photoswitchable agonist MRS7787 allowed the precise modulation of A3R function both in vitro and in vivo, which led to a clear light-controlled pharmacotherapeutic effect on mouse skin lesions, induced by subcutaneous injection of IL-23. This breakthrough not only demonstrates the potential of diazocine photoswitches for in vivo photopharmacology but also paves the way for the development of new strategies for skin-related diseases that require localized and temporally controlled drug action."

Dermatology • Immunology • Psoriasis • IL23A

Molecular basis of ligand binding and receptor activation at the human A3 adenosine receptor. (PubMed, Nat Commun) - "In addition, we identify a cryptic pocket that accommodates the N6-iodobenzyl group of Piclidenoson through a ligand-dependent conformational change of M1745.35. Our comprehensive structural and functional characterisation of A3AR advances our understanding of adenosine receptor pharmacology and establishes a foundation for developing more selective therapeutics for various disorders, including inflammatory diseases, cancer, and glaucoma."

Journal • Glaucoma • Oncology • Ophthalmology

Breakthrough Study from UCLA Demonstrate Can-Fite’s Piclidenoson as a Treatment for Vascular Dementia (GlobeNewswire) - "Can-Fite BioPharma Ltd...announced that a leading group from University of Los Angeles (UCLA), demonstrate that Piclidenoson showed efficacy in an experimental model of vascular dementia...The study headed by Dr. S. Thomas Carmichael...utilized a vascular dementia mouse model with focal ischemia replicating many elements of the complex pathophysiology of human vascular dementia. Piclidenoson was found to restore tissue integrity and behavioral function in this vascular dementia model."

Preclinical • CNS Disorders • Dementia

Can-Fite Has Raised $175 Million in Total to Date for the Development of Namodenoson and Piclidenoson, Advancing into Pivotal Phase 3 Trials in Liver Cancer and Psoriasis (GlobeNewswire) - "Can-Fite BioPharma Ltd...announced that, it has raised $175 million in funding to date. These funds have enabled the advancement of its lead drug candidates, Namodenoson and Piclidenoson, into pivotal Phase III studies for liver cancer and psoriasis, respectively."

Financing • Liver Cancer • Psoriasis

A Phase 3 Study in Moderate-to-Severe Plaque Psoriasis With Piclidenoson to Study Safety and Efficacy (clinicaltrials.gov) - P3 | N=705 | Not yet recruiting | Sponsor: Can-Fite BioPharma | Initiation date: Mar 2025 ➔ Jun 2025

Trial initiation date • Dermatology • Immunology • Psoriasis

Can-Fite to Generate $685M in Projected Future Revenues from its Partnerships (GlobeNewswire) - "Can-Fite BioPharma Ltd....today announced the completion of a comprehensive analysis of its current partnerships and the market potential for its lead drug candidates, Piclidenoson and Namodenoson upon regulatory approvals....Based on in-depth internal modeling and insights from external advisors, the Company forecasts potential substantial revenue generation over the next decade from its two drug candidates, currently in development for four key indications: psoriasis, advanced liver cancer, pancreatic cancer, and MASH, which assumes, among other things, regulatory approval and launches between 2027 and 2029, depending on the indication and territory."

Approval • Commercial • Launch • Hepatocellular Cancer • Liver Cancer • Metabolic Dysfunction-Associated Steatohepatitis • Pancreatic Cancer • Psoriasis

Can-Fite Initiates Pivotal Phase 3 Psoriasis Study of its Oral Drug Piclidenoson with FDA & EMA-Approved Protocol (GlobeNewswire) - "Can-Fite BioPharma Ltd...today announced that it initiated a pivotal phase 3 psoriasis study of its oral drug Piclidenoson with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) - approved clinical study protocol. The study will enroll patients with moderate to severe plaque psoriasis. Patient enrolment will be initiated in Europe and US and Canada expected to follow....Upon positive conclusion of the Phase 3 program, the Company plans to submit a New Drug Application (NDA) to the U.S. FDA and Marketing Authorization Plan (MAA) to the EMA."

EMA filing • FDA filing • Trial status • Psoriasis