Galmed Announces Grant of New Use Patents for the combination of Aramchol and Madrigal Pharmaceuticals' Rezdiffra (Resmetirom) for MASH

Galmed (NASDAQ: GLMD) announced a new use patent in South Korea covering a combination of Aramchol and Madrigal Pharmaceuticals' Rezdiffra (resmetirom) for the treatment of non-alcoholic steatohepatitis (NASH/MASH) and liver fibrosis.

Rhea-AI Summary

Galmed (NASDAQ: GLMD) announced a new use patent in South Korea covering a combination of Aramchol and Madrigal Pharmaceuticals' Rezdiffra (resmetirom) for the treatment of non-alcoholic steatohepatitis (NASH/MASH) and liver fibrosis.

The company says this grant joins earlier patents in the United States, Europe, Canada and other jurisdictions and extends Aramchol's patent protection worldwide, with U.S. protection noted through July 2042. Galmed describes Aramchol as a Phase 3–ready candidate with reported fibrosis improvement and favorable safety and tolerability, positioning it for combination therapy development in MASH.

Positive

• New use patent granted in South Korea for Aramchol+Resmetirom
• Existing patents also held in US, Europe, Canada, other jurisdictions
• U.S. patent protection noted through July 2042
• Aramchol described as Phase 3–ready with fibrosis improvement
• Safety/tolerability cited as suitable for combination therapy

Negative

• No clinical trial results reported for the Aramchol+Resmetirom combination
• No commercial terms, timelines, or regulatory approvals disclosed

Argus Dec 4 session

+5.61% close to close Open Argus

Details

News Market Reaction – GLMD

On Dec 4, the day this news came out, GLMD closed 5.61% above the previous close.

Data tracked by StockTitan Argus for the Dec 4 session.

Key Figures

Patent expiry (U.S.): July 2042

Patent expiry (U.S.)

July 2042

Aramchol worldwide patent protection timeline mentioned in the article

Historical Context

5 past events · Latest: Dec 08

5 events

1. Dec 08

   Conference abstract

   24h Move

   +8.0%

   Late-breaking HEP-DART abstract and planned Phase 1/2 oncology trial for Aramchol.

2. Dec 04

   Patent grant

   24h Move

   +6.5%

   New use patent in South Korea for Aramchol plus Rezdiffra in NASH/MASH.

3. Dec 01

   Shareholder letter

   24h Move

   +3.7%

   CEO letter outlining cash position, fibrosis data and upcoming Aramchol trials.

4. Nov 26

   Earnings update

   24h Move

   +12.4%

   Q3 2025 financials, cash levels, and multiple equity raises alongside clinical updates.

5. Nov 18

   Clinical data

   24h Move

   +3.8%

   Phase 1 Aramchol meglumine bioavailability results supporting once-daily 400 mg dosing.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

non-alcoholic steatohepatitis, metabolic dysfunction-associated steatohepatitis, liver fibrosis, combination therapy, +1 more

5 terms

non-alcoholic steatohepatitis medical

"for the treatment of non-alcoholic steatohepatitis (NASH), also known as"

Non-alcoholic steatohepatitis (NASH) is a liver disease in which fat builds up in liver cells and triggers inflammation and scarring, similar to how clogged, swollen pipes eventually get damaged. For investors it matters because NASH affects a large and growing patient population, has significant health costs and limited approved treatments, and therefore drives demand for new therapies, diagnostics and related medical services that can create sizable market opportunities.

metabolic dysfunction-associated steatohepatitis medical

"NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH), and liver"

Metabolic dysfunction-associated steatohepatitis is a liver disease in which fat buildup tied to metabolic problems such as obesity and diabetes leads to inflammation and scarring, like rust forming inside a machine that gradually impairs function. It matters to investors because its growing prevalence creates large markets for drugs, diagnostics and care, and clinical trial results, approvals, or reimbursement decisions can sharply change the value of healthcare companies working in this area.

liver fibrosis medical

"steatohepatitis (MASH), and liver fibrosis in South Korea."

Liver fibrosis is the gradual buildup of scar tissue in the liver caused by ongoing damage or inflammation. Over time, this scarring can impair the liver’s ability to function properly, similar to how a patchwork quilt made of stiff, thick material can limit flexibility. For investors, increased health issues related to liver fibrosis can impact healthcare demand and influence the financial stability of related industries.

combination therapy medical

"The patent covers the use of a combination therapy of Aramchol and Rezdiffra"

Combination therapy involves using two or more different treatments together to improve overall effectiveness. In healthcare, this means combining medications or approaches to better address a condition, much like using both a screwdriver and a hammer to fix different aspects of a problem. For investors, understanding combination therapy is important because it can influence the success and market potential of new treatments or products in development.

Phase 3 medical

"Aramchol is a first-in-class, Phase 3 ready, drug candidate, that showed"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

The new patent granted in South Korea is added to earlier patents already granted by the United States Patent and Trademark Office (USPTO), Europe, Canada and other jurisdictions and will expire in the U.S. in July 2042.

Aramchol is a first-in-class, Phase 3 ready, drug candidate, that showed robust fibrosis improvement in advanced clinical studies. 

Aramchol's excellent safety and tolerability is a perfect drug candidate to be combined with other MASH drugs, approved or in development.

RAMAT-GAN, Israel, Dec. 4, 2025 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, cardiometabolic diseases and GI oncological therapeutics, announced today the grant of a new Use Patent related to its lead compound, Aramchol. The patent covers the use of a combination therapy of Aramchol and Rezdiffra (MGL-3196, resmetirom) for the treatment of non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH), and liver fibrosis in South Korea.

Previously, Galmed announced the grant of new use patent for a combination of Aramchol and Madrigal Pharmaceuticals' Rezdiffra (Resmetirom) for MASH. The new patent extends Aramchol's patent protection worldwide to July 2042, strengthening its leadership in NASH/MASH combination therapy.

"This patent grant comes at a pivotal moment in the NASH/MASH field, as the industry shifts toward combination therapies to address this complex disease. As commercial interest in MASH is surging, with the limited mild to moderate efficacy demonstrated by monotherapies, initiation of combination MASH clinical studies is necessary and imminent.  We believe Aramchol's excellent safety and tolerability is a perfect drug candidate to be combined with other MASH drugs, approved or in development. The grant of the Aramchol – Rezdiffra new patent is an important step towards the advancement in this direction," said Allen Baharaff, CEO of Galmed Pharmaceuticals.

About Galmed Pharmaceuticals Ltd.:

We are a biopharmaceutical company focused on the development of Aramchol. We have focused almost exclusively on developing Aramchol for the treatment of liver diseases, and continue to actively advance Aramchol for the treatment of combination therapy for NASH. We are also seeking to develop Aramchol for certain oncological indications outside of NASH and fibrosis. In addition, as part of our growth strategy, we are actively pursuing opportunities to expand and diversify our product pipeline specifically targeting cardiometabolic indications and other innovative product candidates that align with our core expertise in drug development.

Forward-Looking Statements:

Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to the potential synergistic effect of Aramchol, Stivarga® and Metformin as a new fixed-dose combination treatment, how such 3-drug combination could potentially become a life-cycle IP strategy, the expected timing of clinical trials, future clinical development and creating value for investors and stakeholders. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the development and approval of the use of Aramchol or any other product candidate for indications outside of non-alcoholic steatohepatitis, or NASH, also known as metabolic dysfunction-associated steatohepatitis, or MASH, and fibrosis or in combination therapy; the timing and cost of any pre-clinical or clinical trials of Aramchol or any other product candidate we develop; completion and receiving favorable results of any pre-clinical or clinical trial; regulatory action with respect to Aramchol or any other product candidate by the U.S. Food and Drug Administration, or the FDA, or the European Medicines Authority, or EMA, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; the commercial launch and future sales of Aramchol and any future product candidates; our ability to comply with all applicable post-market regulatory requirements for Aramchol, or any other product candidate in the countries in which we seek to market the product; our ability to achieve favorable pricing for Aramchol, or any other product candidate; third-party payor reimbursement for Aramchol, or any other product candidate; our estimates regarding anticipated capital requirements and our needs for additional financing; market adoption of Aramchol or any other product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate; our ability to obtain and maintain adequate protection of our intellectual property; the possibility that we may face third-party claims of intellectual property infringement; our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our ability to establish adequate sales, marketing and distribution channels; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; our expectations regarding licensing, acquisitions and strategic operations; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; our ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market; the security, political and economic instability in the Middle East that could harm our business, including due to the current security situation in Israel, risks relating to our digital asset management strategy, including the highly volatile nature of the price of cryptocurrencies and other digital assets, the risk that our share price may be highly correlated to the price of the cryptocurrencies and other digital assets that we may hold, risks related to increased competition in the industries in which we do and will operate, risks relating to significant legal, commercial, regulatory and technical uncertainty regarding cryptocurrencies and other digital assets generally, risks relating to the treatment of crypto assets for U.S. and foreign tax purposes and those risks and uncertainties identified in Exhibit 99.2 to our Report of Foreign Private Issuer on Form 6-K filed with the Securities and Exchange Commission ("SEC") on August 25, 2025. We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in our Annual Report on Form 20-F for the year ended December 31, 2024, filed with the SEC on April 2, 2025 in greater detail under the heading "Risk Factors." Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties.

Logo: https://mma.prnewswire.com/media/1713483/Galmed_Pharmaceuticals_Logo.jpg

 

View original content:https://www.prnewswire.com/news-releases/galmed-announces-grant-of-new-use-patents-for-the-combination-of-aramchol-and-madrigal-pharmaceuticals-rezdiffra-resmetirom-for-mash-302633010.html

SOURCE Galmed Pharmaceuticals Ltd.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What patent did Galmed (GLMD) announce on December 4, 2025?

Galmed announced a new use patent in South Korea for the combination of Aramchol and Rezdiffra (resmetirom) to treat NASH/MASH and liver fibrosis.

How long is Aramchol protected in the U.S. after the new patent grant?

Galmed notes Aramchol's patent protection extends in the U.S. through July 2042.

Does the press release report clinical data for the Aramchol and resmetirom combination?

No; the announcement does not disclose clinical trial results for the Aramchol+resmetirom combination.

What development stage is Aramchol at according to Galmed's announcement?

Aramchol is described as a Phase 3–ready drug candidate with reported fibrosis improvement and favorable safety.

Will the new patent change Galmed's role in NASH/MASH combination therapy?

Galmed says the patent strengthens Aramchol's leadership in combination therapy and supports further combination clinical studies.