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News Breaks
January 22, 2013
09:04 EDTGALTGalectin Therapeutics announces preclinical data on anti-galectin therapy
Galectin Therapeutics announced new preclinical data on the efficacy of anti-galectin therapy on diabetic kidney disease. Treatment of diabetic mice with GR-MD-02 was found to reverse the primary kidney disease associated with diabetes, called diabetic nephropathy, the leading cause of kidney failure, dialysis and kidney transplant. GR-MD-02 is the Company's lead galectin inhibitor in development for the treatment of liver fibrosis, including non-alcoholic steatohepatitis, or NASH, liver disease. In the preclinical study, diabetic mice developed histological findings consistent with diabetic nephropathy, consisting of glomerular lesions in the form of diffuse mesangial matrix accumulation and proliferation. The kidneys of the diabetic mice also showed fibrosis evidenced by interstitial collagen deposition. Treatment with GR-MD-02 reduced the mesangial matrix accumulation, which suggests the drug suppressed the production and/or accumulation of extracellular matrix components. Additionally, GR-MD-02 markedly reduced the area of interstitial fibrosis. These results demonstrate the anti-fibrotic efficacy of GR-MD-02 in the kidney and its therapeutic potential in diabetic nephropathy as well as other chronic kidney diseases.
News For GALT From The Last 14 Days
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March 18, 2015
17:14 EDTGALTGalectin submitted request for SPA with clinical protocol for GR-MD-02 trial
"I am pleased with our many accomplishments during 2014 as we continue to advance programs with GR-MD-02 for the treatment of nonalcoholic steatohepatitis, NASH, with advanced fibrosis. We completed a successful Phase 1 clinical trial and announced final data in January 2015 that were supportive of our plans to begin a Phase 2 program with GR-MD-02 in advanced fatty liver disease, or NASH with fibrosis and cirrhosis," said Peter G. Traber, M.D., president, CEO and chief medical officer of Galectin Therapeutics. "As announced last month, we submitted the Phase 2 clinical trial protocol to the U.S. Food and Drug Administration, FDA, to evaluate the safety and efficacy of GR-MD-02 for the treatment of liver fibrosis and resultant portal hypertension in patients with NASH cirrhosis, the primary endpoint being to determine the change in the hepatic venous pressure gradient, HVPG, as compared with placebo. The FDA has indicated that HVPG may serve as a surrogate primary endpoint for NASH cirrhosis. We submitted a request for a Special Protocol Assessment with the clinical protocol for this trial. Additionally, we are planning to conduct a separate, shorter Phase 2 trial in NASH patients with advanced fibrosis. We expect to begin enrolling patients in both trials during the second quarter of 2015."
17:08 EDTGALTGalectin Therapeutics reports FY14 EPS (78c), consensus (77c)
As of December 31, the company had $29.1M of non-restricted cash and cash equivalents available to fund future operations. In January and February of 2015, the company received $4.1M in net proceeds from the issuance of common shares through its At-the-Market stock issuance program. The company believes that cash on hand of $29.7M as of March 13, is sufficient to fund its operations and research and development activities through September 30, 2016.
March 16, 2015
17:13 EDTGALTGalectin Therapeutics files form to delay 10-K
Galectin Therapeutics is unable to file, without unreasonable effort or expense, its Annual Report on Form 10-K for the period ended December 31. Because the company was previously a smaller reporting company, this is the first time the company must obtain an audit of its internal control over financial reporting. As a result, additional time is needed for the company to provide its independent auditors with information necessary to complete the audit of the company’s internal control over financial reporting. The company anticipates that its Form 10-K will be filed within the prescribed extension period in accordance with Rule 12b-25(b).

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