Welcome to our dedicated page for Can-Fite BioPharma Ltd. news (Ticker: CANF), a resource for investors and traders seeking the latest updates and insights on Can-Fite BioPharma Ltd. stock.
Can-Fite BioPharma Ltd. (CANF) is a clinical-stage biotechnology company whose news flow centers on the development of orally administered small-molecule drugs targeting the A3 adenosine receptor. On this page, readers can follow company announcements on clinical trial progress, regulatory designations, patent developments, financing events, and corporate actions related to its oncology, liver disease, inflammatory, and sexual dysfunction programs.
Recent news has highlighted pivotal and mid-stage clinical studies, including a Phase III trial of Namodenoson in advanced hepatocellular carcinoma, a Phase IIb trial in MASH, and a Phase IIa study in pancreatic cancer. The company has also reported compassionate use cases in advanced liver disease and cirrhosis, as well as long-term survival outcomes in liver cancer patients treated with Namodenoson. For Piclidenoson, updates include Phase III psoriasis development and protocol preparation for rare diseases such as Lowe Syndrome, along with preclinical findings in vascular dementia models.
News items also cover CF602, an A3AR allosteric modulator in development for erectile dysfunction, including patent allowances and grants in markets such as Brazil, the United States, and Europe. Can-Fite regularly reports on its intellectual property strategy, out-licensing and distribution agreements for human and veterinary indications, participation in industry conferences, and capital markets activities such as public offerings, warrant amendments, and share structure changes like reverse splits and ADS ratio adjustments.
Investors and observers can use this CANF news feed to monitor key milestones that may affect the company’s clinical pipeline, regulatory interactions, partnering discussions, and financial position over time.
Can-Fite BioPharma has announced the initiation of a global pivotal Phase III study for Namodenoson, a treatment for advanced liver cancer, also known as hepatocellular carcinoma (HCC). A case report presented at the AASLD’s The Liver Meeting highlights a patient who achieved a complete response after five years of treatment. The pivotal study is open for patient enrollment in various countries, including Israel and the U.S. Namodenoson holds Orphan Drug and Fast Track Status in both the U.S. and Europe.
Can-Fite BioPharma is advancing its Namodenoson liver drug candidate in a Phase IIb NASH study after a successful Phase IIa trial. CEO Dr. Pnina Fishman will present at the H.C. Wainwright 6th Annual NASH Investor Conference on October 17, 2022. NASH represents a significant market opportunity, expected to reach $35-$40 billion by 2025. The ongoing Phase IIb trial will evaluate Namodenoson’s efficacy against placebo in 140 subjects. Namodenoson has shown promise as a treatment for NASH and hepatocellular carcinoma, achieving Orphan Drug and Fast Track Designations.
Can-Fite BioPharma Ltd. (NYSE American: CANF) will be featured in an interview on The RedChip Money Report airing on Bloomberg TV on September 24, 2022, at 7 p.m. ET. CEO Dr. Pnina Fishman will discuss key topics including the Company's Phase 3 trials for Psoriasis and Liver Cancer, and potential $100 million in milestone payments. Can-Fite is advancing therapies in inflammatory, cancer, and liver diseases, with drugs like Namodenoson and Piclidenoson showing promising results in clinical trials. The interview can be accessed in full on Can-Fite’s website.
Can-Fite BioPharma (NYSE American: CANF) announced positive results from the Phase III COMFORT™ study of its psoriasis treatment, Piclidenoson, presented by Dr. Kim Papp at the EADV Congress. The study met its primary endpoint, showing a statistically significant improvement over placebo (p=0.037) at 16 weeks. Piclidenoson demonstrated a safety profile comparable to placebo and better tolerability than Otezla®. The drug is set to progress into a pivotal Phase III registration trial for moderate to severe psoriasis and has shown promise for long-term treatment.
Can-Fite BioPharma Ltd. (NYSE American: CANF) reported financial results for the quarter ending June 30, 2022, showcasing a strong balance sheet with $12.72 million in cash. Key developments include the approval of Namodenoson for compassionate use in Romania and the initiation of a pivotal Phase III study for liver cancer. The Phase III COMFORT trial for psoriasis successfully met its primary endpoint with Piclidenoson. Revenues reached $0.40 million, up 2.7%, while net loss declined to $4.62 million. The company plans to submit registration for Piclidenoson to FDA and EMA.
Can-Fite BioPharma announced that its liver cancer drug Namodenoson has been approved for compassionate use in Romania, showing complete response in at least one patient. The Phase III pivotal study for advanced liver cancer is now open for patient enrollment in multiple countries, including Israel and the U.S. The FDA and EMA have provided regulatory support, and Namodenoson has Orphan Drug and Fast Track status. The liver cancer market is projected to reach $3.8 billion by 2027, reflecting a significant opportunity for Can-Fite.
Can-Fite BioPharma (NYSE: CANF) announced that Dr. Kim A. Papp will present findings from the Phase III COMFORT study at the 31st EADV Congress in Milan on September 10, 2022. The study showed that Piclidenoson significantly improved psoriasis symptoms compared to placebo. Dr. Papp, a leading expert with over 150 studies, is also designing a pivotal Phase III trial for FDA and EMA submission. Can-Fite's drug candidate is positioned to address severe psoriasis, leveraging its unique mechanism of action to inhibit inflammatory cytokines.
Can-Fite BioPharma (NYSE American: CANF) announced the completion of a safety study for Piclidenoson, a treatment for canine osteoarthritis. The efficacy trial will be financed by Vetbiolix, which holds exclusive rights to Piclidenoson for two years. The global market for canine osteoarthritis is anticipated to reach $3 billion by 2028. If successful, Vetbiolix will pay Can-Fite milestone and royalty fees upon regulatory approval. Piclidenoson aims to provide a safer alternative to current NSAID treatments.
Can-Fite BioPharma (CANF) plans to submit registration plans for its lead drug Piclidenoson to the FDA and EMA for treating moderate to severe psoriasis. The company reported positive topline results from its Phase III COMFORT study, demonstrating significant improvement over placebo and a favorable safety profile compared to Otezla. Notably, only 1% of Piclidenoson patients experienced gastrointestinal issues, versus 6% for Otezla. The study involved over 400 patients and showed that those with higher disease severity benefited more from Piclidenoson. Can-Fite aims for strong market positioning with this candidate.
Can-Fite BioPharma reports positive results from its Phase III COMFORT™ trial for Piclidenoson, a treatment for moderate to severe plaque psoriasis. The primary endpoint was met, with significant improvement observed in patients receiving a 3 mg dosage compared to placebo at week 16 (9.7% vs. 2.6%, P0.04). Piclidenoson demonstrated an excellent safety profile, better than Otezla. Can-Fite plans to approach the FDA and EMA for further studies. The company holds five licensing agreements globally for Piclidenoson.