1. Galmed to present its late-breaking abstract at HEP-DART 2025 meeting. 2. Aramchol enhances Bayer's regorafenib effect in GI cancer models. 3. Combination trials of Aramchol and regorafenib planned for 2026. 4. Positive trial results may accelerate clinical development of Aramchol. 5. CEO emphasizes potential value creation for investors and stakeholders.
FAQ
Why Bullish?
The article indicates strong scientific support for Aramchol, which could drive investor confidence. Similar cases, like those of enhanced oncology treatments, often led to price gains post positive announcements.
How important is it?
The focus on a Phase 1/2 trial indicates significant potential for success, leading to increased attention from investors and analysts.
Why Long Term?
Phase 1/2 trials beginning in 2026 suggest a longer-term impact on GLMD’s growth and value, requiring time to evaluate results.
Galmed Pharmaceuticals to Present Late-Breaking Abstract at HEP-DART 2025
Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD), a clinical-stage biopharmaceutical company specializing in therapies for liver, cardiometabolic diseases, and gastrointestinal oncology, has announced the acceptance of a late-breaking abstract for its lead drug candidate, Aramchol. This presentation will take place on December 9, 2025, at 3 PM (HST) during the HEP-DART 2025 Meeting.
Details of the Abstract Presentation
The accepted abstract, titled "Targeting SCD1 enhances activity of standard of care regorafenib in hepatocellular carcinoma: translational rationale for a phase 1/2 study of the combination of Aramchol and regorafenib," highlights the significant findings related to the efficacy of Aramchol alongside Bayer's regorafenib in gastrointestinal cancer models.
Research indicates that SCD1 inhibition significantly boosts the effectiveness of regorafenib (Stivarga®) by activating the ATM-AMPK-autophagy signaling pathway. These results establish a strong foundation for initiating a Phase 1/2 clinical trial that explores the synergistic potential of Aramchol in combination with regorafenib for treating hepatocellular carcinoma (HCC) and other gastrointestinal cancers.
Implications for Future Clinical Trials
Once a recommended Phase 2 dose for the drug combination is established, Galmed plans to introduce a dose expansion cohort that incorporates Metformin, further evaluating the efficacy of this three-drug approach.
Allen Baharaff, CEO of Galmed Pharmaceuticals, stated, "The acceptance of our late-breaking abstract to the HEP-DART prestigious scientific meeting underscores the significance of our data. The research work presented has directly informed VCU Massey Comprehensive Cancer's decision to initiate an investigator-initiated Phase 1/2 clinical trial of Aramchol and regorafenib in advanced GI cancers, including HCC, with planned enrollment starting in 2026." He added, "Positive findings would not only lay the groundwork for subsequent accelerated clinical development of Aramchol in key three GI cancers, but could potentially expand Galmed's oncology pipeline and create value for investors and stakeholders."
About HEP-DART
Founded in 1995, HEP-DART is a leading conference focused on drug development for viral hepatitis and chronic liver diseases. The upcoming HEP-DART 2025 aims to bring together clinicians and researchers to discuss and advance therapeutic knowledge in treating conditions such as viral hepatitis, liver fibrosis, and hepatocellular carcinoma (HCC).
About Galmed Pharmaceuticals Ltd.
Galmed Pharmaceuticals is a dedicated biopharmaceutical entity concentrating on the development of Aramchol. With a primary focus on therapies for liver diseases, the company is actively pursuing advancements in combination therapies for non-alcoholic steatohepatitis (NASH). Moreover, Galmed is exploring the potential of Aramchol for various oncological indications beyond NASH and fibrosis, while also expanding its product pipeline to include innovative treatments targeting cardiometabolic conditions.
Forward-Looking Statements
This announcement contains forward-looking statements, which involve risks and uncertainties that may lead to actual results differing significantly from anticipated outcomes. Factors affecting these forward-looking statements include the development and approval of Aramchol, clinical trial timelines, regulatory actions, and market conditions. Investors are encouraged to monitor Galmed’s progress and consider the associated risks when evaluating potential opportunities related to GLMD.