Galmed Announces Results from First-in-Man Pharmacokinetics Study of Oral Formulation of Aramchol Meglumine (AM); 400mg AM Increases Bioavailability by ~500% in Comparison to Aramchol Free Acid (AA) 300mg

Galmed (NASDAQ: GLMD) reported Phase 1 pharmacokinetics results for its oral formulation Aramchol meglumine (AM) in healthy subjects (Study AM-001).

Rhea-AI Summary

Galmed (NASDAQ: GLMD) reported Phase 1 pharmacokinetics results for its oral formulation Aramchol meglumine (AM) in healthy subjects (Study AM-001).

Single 400mg and 200mg AM doses showed approximately 5-fold and 3-fold higher Aramchol bioavailability versus 300mg Aramchol free acid (AA) tablets. The 400mg AM once-daily dose is intended to match exposure from AA 300mg twice daily.

According to Galmed, this transition may enable GMP clinical batch production, extend Aramchol IP protection, potentially cut drug cost of goods by ~50%, and improve patient convenience and compliance in future MASH and GI oncology uses.

Positive

• 400mg Aramchol meglumine shows ~5-fold higher bioavailability versus 300mg Aramchol free acid
• 200mg Aramchol meglumine shows ~3-fold higher bioavailability versus 300mg Aramchol free acid
• Once-daily 400mg AM aims to replace twice-daily 300mg AA regimen
• Potential ~50% reduction in Aramchol drug cost of goods
• Study AM-001 supports GMP clinical batch production for upcoming trials
• Results may help prolong and solidify Aramchol intellectual property protection

Negative

• None.

Argus May 14 session

+10.62% close to close Open Argus

Details

News Market Reaction – GLMD

In the May 14 session, GLMD gained 10.62%, reflecting a significant positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock surged +10.6% in the session following this news. A strong positive reaction aligns with G...

Analysis

The stock surged +10.6% in the session following this news. A strong positive reaction aligns with Galmed’s history of sharp moves on scientific milestones, such as the 26.14% gain on Apr 9, 2026 after its brain-penetrant formulation news. The PK data showing higher exposure at a 400 mg once-daily dose adds to Aramchol’s platform story, but investors must weigh this against the company’s going-concern warnings and prior Nasdaq minimum bid notice, which highlight financing and listing risks that could cap or reverse enthusiasm.

Key Figures

AM dose: 400 mg Bioavailability increase: 500% Comparator dose: 300 mg +5 more

AM dose

400 mg

Aramchol meglumine once-daily oral dose tested in AM-001

Bioavailability increase

500%

Approximate increase vs 300 mg Aramchol free acid

Comparator dose

300 mg

Aramchol free acid tablets dosed twice daily comparator

Additional AM dose

200 mg

Single AM granule dose evaluated in Phase 1 PK study

Bioavailability (400 mg)

5-fold

Exposure increase vs Aramchol free acid tablets at 400 mg AM

Bioavailability (200 mg)

3-fold

Exposure increase vs Aramchol free acid tablets at 200 mg AM

Prior MASH dose

600 mg

Aramchol dose that reduced liver fat and showed anti-fibrotic effects

Patients exposed

~600 adults

Adults receiving single or multiple Aramchol free acid doses to date

Historical Context

5 past events · Latest: May 06

5 events

1. May 06

   Cardiac fibrosis collaboration

   24h Move

   +6.4%

   Collaboration to develop human-centered chronic cardiac fibrosis platform for Aramchol.

2. Apr 14

   Brain cancer collaboration

   24h Move

   -6.7%

   Collaboration with Tel Aviv University to explore Aramchol for metastatic brain cancers.

3. Apr 09

   Brain-penetrant formulation

   24h Move

   +26.1%

   Announcement of brain-penetrating Aramchol formulation with strong in vitro synuclein data.

4. Mar 31

   Annual 20-F filing

   24h Move

   +8.2%

   20-F highlighting continued losses, going-concern doubt, and heavy dependence on Aramchol.

5. Jan 30

   Nasdaq bid notice

   24h Move

   -6.3%

   Nasdaq notification for failing to meet the $1.00 minimum bid price requirement.

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

Key Terms

pharmacokinetics, bioavailability, gmp, cogs, +4 more

8 terms

pharmacokinetics medical

"Results from First-in-Man Pharmacokinetics Study of Oral Formulation of Aramchol"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

bioavailability medical

"400mg AM Increases Bioavailability by ~500% in Comparison to Aramchol free acid"

Bioavailability is the measure of how much and how quickly a substance, such as a medication or nutrient, enters the bloodstream and becomes available for use by the body. For investors, it matters because it influences how effectively a product works and how quickly results are seen, which can impact a company's success and the potential value of related investments. Think of it like how much of a medicine actually reaches your bloodstream after taking it—that determines how well it can do its job.

gmp technical

"Production of GMP clinical batch for Galmed's upcoming clinical trials"

Good Manufacturing Practice (GMP) is a set of regulatory standards and procedures that ensure products—especially medicines, medical devices, and related goods—are consistently made to meet safety, quality, and purity requirements. For investors, GMP compliance is like a factory’s hygiene and checklist system: it reduces the risk of product recalls, regulatory fines, and production stoppages, supports market access, and signals more reliable, lower-risk operations that can protect revenue and reputation.

cogs financial

"Potential reduction in drug CoGs by ~50%"

Cost of goods sold (COGS) is the direct cost a company incurs to produce or purchase the products it sells, including raw materials, production labor, and factory overhead tied to making the items. Investors track COGS because it directly affects gross profit and shows how efficiently a business converts inputs into saleable products — like how much a baker spends to make a loaf versus the price it sells for; rising COGS without higher selling prices can squeeze profit margins and valuation.

View in glossary

phase 1 medical

"announced today major milestone results from a Phase 1 PK study in healthy subjects"

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

pk medical

"Phase 1 PK study in healthy subjects (Study AM-001)"

Pharmacokinetics (PK) describes how a drug moves through the body—how quickly it is absorbed, how it spreads to tissues, how the body breaks it down, and how it is eliminated. For investors, PK data help predict whether a medicine can reach effective levels without causing harm, how often it must be dosed, and whether drug interactions or patient differences could affect commercial success; think of it as the drug’s travel and timing profile inside the body.

stearoyl coa desaturase 1 medical

"Aramchol down-regulates stearoyl CoA desaturase 1 (SCD1) in hepatocytes"

Stearoyl‑CoA desaturase 1 (SCD1) is an enzyme that converts saturated fats into monounsaturated fats, influencing cell membrane composition, energy storage and how cells handle lipids. Investors watch SCD1 because it’s a common drug target and biomarker for metabolic diseases, liver disorders and some cancers; advances or setbacks in SCD1‑related research, patents or approvals can change a company’s prospects much like news about a crucial component affects a manufacturer’s outlook.

hepatocellular carcinoma medical

"often leading to cirrhosis, liver failure and sometimes to hepatocellular carcinoma"

Hepatocellular carcinoma is the most common form of primary liver cancer, arising from the main functional cells of the liver. For investors it matters because its serious health impact drives demand for diagnostic tests, treatments and long-term care; progress in trials or approvals can change a drugmaker’s revenue outlook much like a successful product launch can reshape a company’s future.

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

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Results from Study AM-001 mark a pivotal advance through the transition to a once daily lower 400mg dose of AM enabling:

• Production of GMP clinical batch for Galmed's upcoming clinical trials
• Solidification and prolongation of Aramchol's IP protection
• Potential reduction in drug CoGs by ~50%
• Improvement in patients' convenience and compliance upon potential commercialization

RAMAT-GAN, Israel, May 14, 2026 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver disease and GI oncological therapeutics, announced today major milestone results from a Phase 1 PK study in healthy subjects (Study AM-001). The overall objective of the study was to identify the dose of Aramchol meglumine (AM) administered once daily that produces similar exposure to Aramchol from 300mg Aramchol free acid (AA) tablets dosed twice daily. Single doses of AM granules for oral suspension of 400 mg and 200mg were evaluated and compared to AA 300mg tablet. The study demonstrated that the bioavailability of Aramchol from the Aramchol meglumine granules for oral suspension is considerably greater (approximately 5-fold and 3-fold respectively) than that from Aramchol free acid tablets. An additional PK study (AM-003) comparing AM 400mg tablets once daily with AA 300mg tablets twice daily is ongoing. 

Aramchol down-regulates stearoyl CoA desaturase 1 (SCD1) in hepatocytes and in hepatic stellate cells (HSC's) and other tissues including various cancers. Metabolic-dysfunction associated steatohepatitis (MASH) (previously called non-alcoholic steatohepatitis (NASH)) is a common serious type of fatty liver disease often leading to cirrhosis, liver failure and sometimes to hepatocellular carcinoma. In Phase 2 and Phase 3 (open label part) clinical trials 600mg Aramchol reduced liver fat, attenuated steatohepatitis and demonstrated robust anti-fibrotic effects. To date ~ 600 adults have received single or multiple doses of Aramchol free acid, including ~240 healthy subjects and 360 patients with MASH.

Allen Baharaff, Galmed's Co-founder and CEO, commented: "A once daily lower dose of Aramchol meglumine is advantageous for compliance as monotherapy or in combination with other MASH candidates. Aramchol is currently being evaluated in multiple pre-clinical studies to overcome drug resistance and enhance the efficacy of standard-of-care (SoC) oncology agents for GI cancer treatments. A higher exposure will be needed in order to leverage Aramchol's multi-system therapeutic potential, well beyond its initial MASH applications. We believe that today's announced pivotal development positions Aramchol as a potential valuable tool in the arsenal of treatments for GI conditions including MASH and GI cancers and strengthens Galmed position in the GI space."

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 disease, and we are currently seeking to advance the development of Aramchol for oncological indications beyond 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 and neurological 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 commercialization of Aramchol, the Company's belief that the pivotal development positions Aramchol as a potential valuable tool in the arsenal of treatments for GI conditions including MASH and GI cancers and strengthens Galmed position in the GI space. 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; and the security, political and economic instability in the Middle East that could harm our business, including due to the current security situation in Israel. 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, 2025, filed with the SEC on March 31, 2026 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.

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SOURCE Galmed Pharmaceuticals Ltd.

FAQ

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

What did Galmed (NASDAQ: GLMD) announce about Aramchol meglumine 400mg bioavailability on May 14, 2026?

Galmed announced that 400mg Aramchol meglumine achieved about five times higher Aramchol bioavailability than 300mg Aramchol free acid. According to Galmed, this once-daily 400mg AM dose is designed to provide similar exposure to AA 300mg tablets taken twice daily.

How does Aramchol meglumine 200mg compare to Aramchol free acid 300mg in the GLMD Phase 1 PK study?

Aramchol meglumine 200mg showed approximately three-fold higher Aramchol bioavailability than Aramchol free acid 300mg tablets. According to Galmed, both 200mg and 400mg AM oral suspension doses were evaluated against AA 300mg in healthy subjects in Phase 1 Study AM-001.

What is the goal of Galmed’s Study AM-001 for Aramchol meglumine (GLMD)?

The goal of Study AM-001 was to find a once-daily Aramchol meglumine dose matching exposure from AA 300mg twice daily. According to Galmed, the 400mg AM dose is intended to transition treatment from higher, twice-daily Aramchol free acid tablets.

How could the new Aramchol meglumine 400mg formulation affect Galmed’s drug costs and IP?

Galmed indicates the 400mg AM formulation could potentially reduce Aramchol drug cost of goods by about 50%. According to Galmed, the new formulation also helps solidify and prolong Aramchol intellectual property protection, supporting future clinical and commercial planning.

What are the next clinical steps for Aramchol meglumine (GLMD) after Study AM-001?

An additional PK study, AM-003, is ongoing, comparing AM 400mg tablets once daily with AA 300mg tablets twice daily. According to Galmed, AM-001 results also support GMP clinical batch production for upcoming trials in MASH and GI oncology indications.

How many adults have been exposed to Aramchol in previous Galmed MASH trials?

Approximately 600 adults have received single or multiple doses of Aramchol free acid in prior studies. According to Galmed, this includes around 240 healthy subjects and 360 patients with metabolic-dysfunction associated steatohepatitis (MASH) from Phase 2 and Phase 3 open-label trials.

What therapeutic areas is Galmed targeting with Aramchol and Aramchol meglumine (GLMD)?

Galmed is targeting MASH and gastrointestinal cancers with Aramchol-based therapies. According to Galmed, Aramchol down-regulates SCD1 in hepatocytes, hepatic stellate cells and other tissues, and is being evaluated in pre-clinical studies alongside standard-of-care oncology agents for GI cancer treatments.