STOCK TITAN

Galmed Pharmaceuticals Ltd. - GLMD STOCK NEWS

Welcome to our dedicated page for Galmed Pharmaceuticals Ltd. news (Ticker: GLMD), a resource for investors and traders seeking the latest updates and insights on Galmed Pharmaceuticals Ltd. stock.

Galmed Pharmaceuticals Ltd. (GLMD) is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative treatments for liver diseases and fibrotic conditions. Established in Israel on July 31, 2013, but with operations dating back to 2000, Galmed focuses on the development of Aramchol, a proprietary first-in-class synthetic fatty-acid/bile-acid conjugate (FABAC). Aramchol is a once-daily, oral therapy designed to address serious liver disorders such as Non-Alcoholic Steato-Hepatitis (NASH) and Primary Sclerosing Cholangitis (PSC).

Recent Achievements and Projects

  • Galmed recently announced a strategic partnership with OnKai to utilize artificial intelligence (AI) for improving clinical trial enrollment and execution, particularly focusing on PSC.
  • The company completed a securities purchase agreement with institutional investors, raising approximately $7 million, which will bolster its ongoing and future clinical trials.
  • A granted Japanese patent extends Aramchol’s protection until November 2037, enhancing its IP portfolio and potential market exclusivity.

Financial Condition

  • Galmed is listed on the Nasdaq Capital Market under the symbol GLMD and is actively pursuing compliance with Nasdaq's listing requirements, including maintaining a minimum bid price of $1.00 per share.
  • The company’s recent fundraising efforts and careful financial management are geared towards advancing its clinical programs and ensuring sustainable growth.

Partnerships and Collaborations

  • Galmed collaborates with various academic institutions, including the Hebrew University, to develop additional therapeutic candidates like Amilo-5MER, a 5-amino acid synthetic peptide.

Products and Pipeline

  • Aramchol: Primarily developed for treating NASH and PSC, Aramchol has shown promising anti-fibrotic effects in pre-clinical and clinical studies.
  • Amilo-5MER: Currently under development for potential applications in treating other fibro-inflammatory conditions.

In summary, Galmed Pharmaceuticals is at the forefront of developing transformative therapies for liver and fibrotic diseases. With its robust pipeline, strategic partnerships, and strong financial strategies, the company is well-positioned to make significant advancements in the biopharmaceutical field.

-
Rhea-AI Summary

Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) has filed its Annual Report on Form 20-F for the fiscal year ending December 31, 2022, with the SEC. The report details their development of Aramchol for liver diseases and includes risks associated with clinical trials and regulatory approvals. Shareholders can access the report via the SEC and the company's Investor Relations website. Galmed remains focused on advancing Aramchol and collaborating on the development of other therapies, including Amilo-5MER.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
4.44%
Tags
-
Rhea-AI Summary

Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced that the U.S. Patent and Trademark Office granted patent 11,571,431 B2, extending Aramchol's exclusivity to December 2034. This patent protects Aramchol's use, particularly in treating NASH and Fibrosis, and fortifies its existing patent portfolio, which now encompasses over 20 issued patents worldwide. The N-methylglucamine salt form, noted for its advantageous properties, enhances absorption and bioavailability. CEO Allen Baharaff emphasized that this patent strengthens their ability to maximize Aramchol's therapeutic potential across various indications.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-0.29%
Tags
none
Rhea-AI Summary

Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) announced significant findings from the ARMOR study regarding their treatment Aramchol for NASH. The study revealed a 39% improvement in fibrosis and a 61% improvement based on ranked assessments. Key results included a highly statistically significant reduction in liver stiffness and liver injury markers (ALT and AST), all showing p-values <0.0001. Galmed plans to submit this data to the FDA for consideration of advanced histology reading methodologies as primary endpoints in future NASH studies.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
9.28%
Tags
none
-
Rhea-AI Summary

Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced on December 13, 2022, that it received an extension from Nasdaq to regain compliance with the minimum bid price requirement of $1 per share. This new compliance period extends until June 12, 2023, following an initial notification on June 17, 2022. The company must close at or above $1 for 10 consecutive trading days to achieve compliance. Galmed is focused on developing Aramchol and Amilo-5MER, targeting liver disease treatment.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-3.33%
Tags
none
-
Rhea-AI Summary

Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) reported its financial results for the second quarter of 2022, revealing a net loss of $3.7 million ($0.15 per share), a decrease from $8.4 million ($0.33 per share) in Q2 2021. Cash and equivalents totaled $22.5 million by June 30, 2022, down from $34.9 million at the end of 2021. The company is discontinuing the Open Label Part of the ARMOR study to redirect efforts towards new anti-fibrotic indications and implementing a cost-reduction plan, including staff cuts. R&D expenses fell to $2.6 million from $7 million in 2021.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-9.46%
Tags
Rhea-AI Summary

Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced significant clinical results for Aramchol, showing substantial anti-fibrotic effects in pre-clinical models of lung and gastrointestinal fibrosis. In lung fibrosis, Aramchol demonstrated improvements comparable to the standard treatment, Pirfenidone, with notable statistical significance (P<0.001 to P<0.005). The drug also showed promising results in a model of inflammatory bowel disease (IBD), outperforming current gold standard treatments. The company aims to expand Aramchol's clinical development for additional indications.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-0.49%
Tags
none
-
Rhea-AI Summary

Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) announced that it has received a notification from Nasdaq, stating that it is not in compliance with the minimum bid price requirement of $1.00 per share. The company has until December 12, 2022, to regain compliance by maintaining this price for ten consecutive business days. If compliance is not achieved, Galmed may face delisting. During this grace period, shares will continue to trade normally. The company is developing treatments for liver and metabolic diseases, including its lead compound, Aramchol™, currently in Phase 3 trials.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
6.35%
Tags
none
-
Rhea-AI Summary

Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) reported its financial results for Q1 2022, highlighting a net loss of $6.1 million ($0.24 per share), an improvement from a loss of $8.9 million ($0.38 per share) in Q1 2021. Cash and equivalents decreased to $28.9 million from $34.9 million at year-end 2021. R&D expenses fell to $4.8 million from $7.4 million, while G&A expenses also decreased to $1.3 million from $1.8 million. The company is expanding its clinical strategy into new anti-fibrotic indications while discontinuing the Open Label Part of the Armor Study, having achieved its objectives.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
1.74%
Tags
Rhea-AI Summary

Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) has announced a strategic shift in its clinical development plan to expand the use of its lead compound, Aramchol, into new anti-fibrotic indications. This follows positive outcomes from the Open-Label Part of the ARMOR study, demonstrating consistent anti-fibrotic effects at 48 weeks in NASH patients. The Open-Label study will be discontinued as its objectives are met. Cost reduction efforts will facilitate a faster transition to high unmet need areas. The company is also evaluating strategic alternatives to enhance shareholder value and plans to commence the registrational study in the latter half of 2023.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
1.74%
Tags

FAQ

What is the current stock price of Galmed Pharmaceuticals Ltd. (GLMD)?

The current stock price of Galmed Pharmaceuticals Ltd. (GLMD) is $3.03 as of December 23, 2024.

What is the market cap of Galmed Pharmaceuticals Ltd. (GLMD)?

The market cap of Galmed Pharmaceuticals Ltd. (GLMD) is approximately 5.1M.

What is the primary focus of Galmed Pharmaceuticals?

Galmed Pharmaceuticals focuses on developing and commercializing Aramchol, an oral therapy for liver diseases like NASH and PSC.

What are Galmed Pharmaceuticals' recent achievements?

Recent achievements include a strategic AI partnership with OnKai, raising $7 million through a securities purchase agreement, and obtaining a Japanese patent for Aramchol.

What is Aramchol?

Aramchol is a first-in-class synthetic fatty-acid/bile-acid conjugate (FABAC) developed as an oral therapy for liver diseases, including NASH and PSC.

What other products are in Galmed's pipeline?

Besides Aramchol, Galmed is developing Amilo-5MER, a 5-amino acid synthetic peptide for treating fibro-inflammatory diseases.

What financial measures has Galmed taken recently?

Galmed raised approximately $7 million through a securities purchase agreement to support its clinical trials and ongoing projects.

With whom does Galmed Pharmaceuticals collaborate?

Galmed collaborates with OnKai for AI-driven clinical trials and the Hebrew University for developing Amilo-5MER.

How is Galmed addressing compliance with Nasdaq listing requirements?

Galmed is working to maintain a minimum bid price of $1.00 per share and has 180 days to regain compliance with Nasdaq's requirements.

What is the significance of Galmed's recent patent approvals?

The Japanese patent extends protection for Aramchol until 2037, ensuring market exclusivity and enhancing its intellectual property portfolio.

Are there any delays in Galmed's clinical trials?

Yes, due to unforeseen events, the initiation of the Phase 2a PSC study has been delayed by 6-9 months.

What is the goal of the partnership with OnKai?

The partnership aims to use AI to improve the enrollment and execution of clinical trials, particularly focusing on underrepresented communities.

Galmed Pharmaceuticals Ltd.

Nasdaq:GLMD

GLMD Rankings

GLMD Stock Data

5.14M
1.49M
1.29%
0.49%
3.04%
Biotechnology
Healthcare
Link
United States of America
Ramat Gan