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News Breaks
August 7, 2014
17:41 EDTGALTGalectin Therapeutics reports Q2 EPS (17c), consensus (21c)
"We continued to be encouraged by the progress in our development program. We announced on July 29, the results of the second cohort of patients in our Phase 1 clinical trial for patients with NASH with advanced fibrosis which demonstrated that double the dose of GR-MD-02 that was used in the first cohort was safe and well tolerated. We also have begun recruitment and enrollment of the third cohort of the Phase 1 clinical trial, that we expect will be concluded such that results may be presented in November 2014," said Peter G. Traber, M.D., CEO, President and Chief Medical Officer, Galectin Therapeutics. "This Phase 1 first-in-man study is evaluating the safety, tolerability, pharmacokinetics and exploratory biomarkers for efficacy for single and multiple doses of GR-MD-02 when administered to patients with fatty liver disease with advanced fibrosis. Additionally, we recently announced that the first patient has been dosed in cohort 1 of a Phase 1B clinical trial evaluating GR-MD-02 in combination with ipilimumab (Yervoy(R)) in patients with metastatic melanoma. Preclinical data have shown that GR-MD-02 holds immense potential for increasing the effectiveness of other therapies and may be an important approach in enhancing cancer immunotherapy." At June 30, the company had $34.4M of non-restricted cash and cash equivalents which it believes will be sufficient to fund currently planned future operations, research and development through mid-2016.
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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