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Galmed (NASDAQ: GLMD) tests Xtandi combo as patents, price cuts loom

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6-K

Rhea-AI Filing Summary

Galmed Pharmaceuticals Ltd. (GLMD), a clinical-stage biopharmaceutical company, reported new pre-clinical data on a combination of its SCD1 inhibitor Aramchol with Xtandi® (enzalutamide) in prostate cancer models. In a VCaP prostate cancer cell line, the combination produced a 3–4-fold increase in cell death compared with enzalutamide alone, with the interaction strengthening over time.

Galmed links this effect to blocking tumor lipid desaturation pathways that support resistance to standard-of-care anti-androgen therapy. The company highlights that Xtandi recorded $8 billion and $6 billion in global sales in 2024 and 2025 and faces main patent expirations in 2026 (Europe) and 2027 (U.S.), with a U.S. price cut scheduled for 2027.

Galmed has submitted a patent application covering the Aramchol–enzalutamide combination and plans to initiate discussions with potential partners as a possible lifecycle management strategy around Xtandi and future generic competition. In parallel, Galmed continues to advance Aramchol and its CG-100 colorectal surgery device for gastrointestinal, cardiometabolic and oncology indications.

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Filing Explained

Galmed’s August 17 Form 6-K incorporates the press release’s first and fourth paragraphs into specified S-8 and F-3 registration statements; the stated action is adding information to those registrations, rather than reporting an offer or issuance of shares.

Increase in cell death with combination 3–4-fold Cell death increase for Aramchol plus enzalutamide versus enzalutamide alone in VCaP prostate cancer cell line
Xtandi global sales 2024 $8 billion Global sales for Xtandi® in 2024
Xtandi global sales 2025 $6 billion Global sales for Xtandi® in 2025
Share of Pfizer revenue 4% Xtandi® sales accounting for roughly 4% of Pfizer’s total revenue
Enzalutamide patent expiry Europe 2026 Main composition of matter patents for enzalutamide expire in Europe in 2026
Enzalutamide patent expiry U.S. 2027 Main composition of matter patents for enzalutamide expire in the United States in 2027
U.S. price cut start for Xtandi 2027 U.S. price cut for enzalutamide (Xtandi®) scheduled to begin in 2027
VCaP prostate cancer cell line medical
"New data from a VCaP prostate cancer cell line that features high expression"
SCD1 inhibitor medical
"Aramchol (an SCD1 inhibitor) with enzalutamide resulted in 3–4-fold increase"
An SCD1 inhibitor is a drug that blocks the action of the protein stearoyl‑CoA desaturase‑1, which helps cells make certain types of fats. For investors, it matters because slowing or stopping that biochemical step can change how diseases tied to fat metabolism (like fatty liver, obesity-related conditions, and some cancers) behave, so such drugs carry both potential market opportunity and clinical development risk—like turning down a factory machine that alters many downstream products.
androgen receptor blocker medical
"Combining enzalutamide (an androgen receptor blocker) with an SCD1 inhibitor blocks"
A drug that binds to androgen receptors on cells and prevents male hormones like testosterone and dihydrotestosterone from activating those receptors, blocking the downstream signals that drive cell growth and function. Think of it like putting a cover over a lock so the hormone key can’t turn it. It matters to investors because these drugs are central to treating hormone-driven diseases, so their safety, effectiveness, patent status, and regulatory progress directly affect clinical value and market potential.
composition of matter patents regulatory
"The main composition of matter patents for enzalutamide (sold as Xtandi) expire"
Composition of matter patents are legal rights that cover new chemical substances, mixtures, materials or formulations — imagine a recipe or unique material recipe that no one else can legally copy. For investors, they matter because they create temporary exclusivity that can protect a product from competitors, support higher pricing or licensing revenue, and therefore influence a company’s future sales, valuation and risk profile when the patent expires or is challenged.
lifecycle management financial
"could potentially become a lifecycle management for Xtandi® in light of the U.S."
Lifecycle management is the ongoing process of guiding a product or asset from creation through growth, maturity and eventual phase-out to get the most value from it. Investors care because good lifecycle management—like tending a garden or maintaining a car—extends revenue, reduces costs and can delay or soften declines by adding improvements, finding new markets, adjusting pricing, and meeting regulatory requirements, which directly affects a company’s profits and stock value.
GnRH analogue medical
"including combining Aramchol with enzalutamide (with or without GnRH analogue)"
A GnRH analogue is a synthetic version of gonadotropin-releasing hormone that acts on the brain’s pituitary gland to either stimulate or suppress the production of sex hormones such as estrogen and testosterone. Think of it like a thermostat for the body’s reproductive hormone system: by dialing the signal up or down, it is used in medicines for conditions ranging from infertility to hormone-sensitive cancers and puberty disorders, and its clinical trial results, approvals, patent status, and prescribing use can materially affect pharmaceutical company revenues and regulatory risk.

FAQ

What did Galmed Pharmaceuticals (GLMD) report in its August 2026 Form 6-K?
Galmed reported pre-clinical results showing that combining Aramchol with Xtandi® (enzalutamide) increased prostate cancer cell death 3–4-fold versus enzalutamide alone. The data support further evaluation of Aramchol combinations to address resistance in difficult-to-treat prostate cancer.

How strong was the Aramchol and Xtandi® effect described by GLMD?
In a VCaP prostate cancer cell line, Galmed observed a 3–4-fold increase in cell death when Aramchol was combined with enzalutamide versus enzalutamide alone. The company notes that the interaction became stronger the longer both drugs were present in the model.

Why does Galmed (GLMD) see strategic value around Xtandi® patents and pricing?
Galmed notes Xtandi® global sales of $8 billion in 2024 and $6 billion in 2025, with key patents expiring in 2026 (Europe) and 2027 (U.S.) and a U.S. price cut in 2027. It positions the Aramchol combination as potential lifecycle management and differentiation for this market.

What partnering plans did Galmed Pharmaceuticals (GLMD) outline for Aramchol in prostate cancer?
Galmed stated it has submitted a patent application covering the Aramchol–enzalutamide combination and is planning to initiate discussions with potential partners. The goal is to explore development and commercialization opportunities in the multibillion-dollar prostate cancer market.

Beyond prostate oncology, what other areas is Galmed (GLMD) developing products in?
Galmed is advancing Aramchol and related candidates for gastrointestinal, cardiometabolic, and oncology indications, and through subsidiary Colospan Ltd., is developing CG-100, a medical device aimed at reducing complications after colorectal surgery, as part of a diversified GI-focused platform.

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

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Form 6-K: How Foreign Companies Report to the SEC →

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16

Under the Securities Exchange Act of 1934

 

For the Month of August 2026

 

001-36345

(Commission File Number)

 

GALMED PHARMACEUTICALS LTD.

(Exact name of Registrant as specified in its charter)

 

c/o Meitar Law Offices Abba Hillel Silver Rd.,

Ramat Gan, 5250608

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

 

Form 20-F ☒ Form 40-F ☐

 

 

 

 

 

 

On August 17, 2026, Galmed Pharmaceuticals Ltd. (the “Company”) issued a press release entitled “Galmed Announces First Time Results in Prostate Oncology Studies: Aramchol Demonstrates 3-4 Fold Increase in Cell Death Compared to Enzalutamide (XTANDI®) Alone in Prostate Cancer Models.” A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

 

The first and fourth paragraphs of the press release attached as Exhibit 99.1 to this Form 6-K are hereby incorporated by reference into the Company’s Registration Statements on Form S-8 (Registration Nos. 333-206292, 333-227441, 333-284163, and 333-290399) and the Company’s Registration Statements on Form F-3 (Registration Nos. 333-272722 and 333-283241).

 

 

 

 

EXHIBIT INDEX

 

Exhibit No.   Description
     
99.1   Press Release, dated August 17, 2026.

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  Galmed Pharmaceuticals Ltd.
     
Date: August 17, 2026 By: /s/ Allen Baharaff
    Allen Baharaff
    President and Chief Executive Officer

 

 

 

 

Exhibit 99.1

 

Galmed Announces First Time Results in Prostate Oncology Studies: Aramchol Demonstrates 3-4 Fold Increase in Cell Death Compared to Enzalutamide (XTANDI®) Alone in Prostate Cancer Models

 

●Xtandi® (enzalutamide) is indicated as monotherapy for the treatment of patients with non-metastatic prostate cancer (nmCSPC) at high risk of metastasis and for the treatment of patients with metastatic prostate cancer (mCSPC) who are maintaining treatment with a GnRH analogue.
   
●Global sales for Xtandi® (marketed by Astellas Pharma and Pfizer) reached approximately $8 billion and $6 billion globally in 2024 and 2025, respectively.
   
●The main composition of matter patents for enzalutamide (sold as Xtandi) expire in 2026 in Europe and 2027 in the United States (Patent US9126941 & Patent US8183274) with a U.S. price cut scheduled to begin in 2027.
   
●New data from a VCaP prostate cancer cell line that features high expression of wild-type androgen receptors, demonstrated that a combination of Aramchol with enzalutamide resulted in 3–4-fold increase in cell death compared with enzalutamide as a single agent.

 

RAMAT-GAN, Israel, Aug. 17, 2026 /PRNewswire/ — Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) (“Galmed” or the “Company”), a clinical-stage biopharmaceutical company focused on liver, cardiometabolic and oncology diseases, today announced significant results from a pre-clinical study of a combination of Aramchol and Xtandi® (enzalutamide) for prostatic cancer.

 

Prostate cancer is the second most common cancer in men worldwide and remains a significant cause of cancer-related morbidity and mortality. Androgen signaling plays a central role in the development and progression of prostate cancer. For this reason, anti-androgen therapy and related androgen axis-targeting approaches represent important modalities in the treatment of prostate cancer. Despite the availability of anti-androgen therapies, there remains a need for improved treatment regimens that may be used alone or in combination with existing anti-androgen therapies, including in patients having resistant, recurrent, advanced, metastatic, or otherwise difficult-to-treat prostate cancer.

 

Recent publications indicate that prostate cancer tumors can adapt to SoC treatments such as enzalutamide by altering their lipid metabolism. Both enzalutamide-sensitive and resistant cells depend on this lipid desaturation pathway. Combining enzalutamide (an androgen receptor blocker) with an SCD1 inhibitor blocks this lipid synthesis and desaturation, potentially leading to decreased cell viability, and delayed development of drug resistance.

 

The data we present today, demonstrate that a combination of Aramchol (an SCD1 inhibitor) with enzalutamide resulted in 3–4-fold increase in cell death (compared with enzalutamide as a single agent) and that the interaction gets stronger, the longer the drugs are on board. The VCaP prostate cancer cell line features high expression of wild-type androgen receptors, the clinically relevant AR-V7 splice variant, and the TMPRSS2-ERG gene fusion, sourced from a vertebral metastasis of a 59 year old Caucasian mCSPC patient.

 

Previously Galmed demonstrated that Aramchol synergistically interacts with docetaxel (Taxotere®) a potent, semisynthetic chemotherapy medication, to cause greater than additive killing in a whole range of tumor types where docetaxel is approved, including prostate cancer cells. The results from those studies support the further evaluation of Aramchol in combination with approved prostate cancer therapies, including combining Aramchol with enzalutamide (with or without GnRH analogue) and as the anti-androgen interaction starts to wear off, switch to a combination of Aramchol with docetaxel.

 

Allen Baharaff, Galmed’s Co-founder and CEO, commented: “The data we present today is a result of our research work in prevention of drug resistance to blockbuster agents in oncology (as previously reported in our earlier press releases). Global sales for Xtandi® (marketed by Astellas Pharma and Pfizer) reached approximately $8 billion and $6 billion globally in 2024 and 2025 (accounting for roughly 4% of Pfizer’s total revenue). The main composition of matter patents for enzalutamide (sold as Xtandi®) expire in 2026 in Europe and 2027 in the United States (Patent US9126941 & Patent US8183274). A combination of Aramchol and enzalutamide could potentially become a lifecycle management for Xtandi® in light of the U.S. price cut scheduled to begin in 2027 as well as a key differentiating factor for any generic competitor trying to capture a portion of this multibillion-dollar market. Galmed is planning to initiate discussions with potential partners based on a patent application for the combination that has been recently submitted”.

 

 

 

 

About Galmed Pharmaceuticals Ltd.:

 

Galmed Pharmaceuticals Ltd. is a biopharmaceutical and medical device company focused on developing innovative solutions for gastrointestinal, cardiometabolic and oncology indications. The Company is advancing Aramchol and related product candidates for GI oncology and other potential indications, while also exploring novel targeted delivery technologies and therapeutic approaches for cardiometabolic diseases. In addition, through its wholly owned subsidiary, Colospan Ltd., the Company is developing and commercializing CG-100, a medical device designed to address complications associated with colorectal surgery. Galmed’s strategy is to build a diversified platform that leverages its expertise in drug development, medical devices and gastrointestinal disease to address significant unmet medical needs.

 

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 how a combination of Aramchol and enzalutamide could potentially become a lifecycle management for Xtandi® in light of the U.S. price cut scheduled to begin in 2027 as well as a key differentiating factor for any generic competitor trying to capture a portion of this multibillion-dollar market and how Galmed is planning to initiate discussions with potential partners based on a patent application for the combination that has been recently submitted. 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, our inability to recognize the anticipated benefits of the acquisition of Colospan; expectations with respect to future performance and growth of Colospan; 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 CG-100, Aramchol or any other medical device or product candidate we develop; completion and receiving favorable results of any pre-clinical or clinical trial; regulatory action with respect to CG-100, Aramchol or any other medical device or 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 CG-100, Aramchol and any future medical devices or product candidates; our ability to comply with all applicable post-market regulatory requirements for CG-100, Aramchol, or any other medical device or product candidate in the countries in which we seek to market the product; our ability to achieve favorable pricing for CG-100, Aramchol, or any medical device or other product candidate; third-party payor reimbursement for CG-100, Aramchol, or any other medical device or product candidate; our estimates regarding anticipated capital requirements and our needs for additional financing; market adoption of CG-100 Aramchol or any other medical device or product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of CG-100, Aramchol or any other medical device or 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 CG-100 or 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.

 

Investor and Media contact:

 

Guy Nehemya, +972-3-693-8448, investor.relations@galmedpharma.com

 

 

 

Source: View Original Filing on SEC EDGAR

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