Naz News, Gappers and FLE's

[MiamiGent]

GALT Correction: ICPT met its endpoints, not GALT as I stated in the linked post.
GALT moved up today because 1) Like ICPT, GALT is engaged in R&D of liver disease (see emboldened in article below) 2) Company published a 2013 summary yesterday (see 2nd article below) 3) Company announced Monday it had been granted a patent (see 3rd article below).

GALT added 20 points in AH session, closing at 13.69
Let's see what the morrow brings.
MG

http://stockcharts.com/h-sc/ui?s=GALT


UPDATE: Intercept Pharmaceuticals Gives Sector Shot In Arm After Announcing NASH Primary Endpoint Met
BY Midnight Trader — 1:17 PM ET 01/09/2014

Shares of ICPT are up close to 300% and have hit a record high of $305 after the company said early today that its trial to study obeticholic adic (OCA) for the treatment of nonalcoholic steatohepatitis (NASH) has been stopped earlier than planned after already meeting the primary endpoint. Analysts claim the decision to end trials is an indication of the rush to make available a treatment for NASH, a disease that Intercept CEO claims is at "epidemic proportions."

As a result of the ICPT news, other pharmaceutical companies engaged in the research and development of treatments for liver diseases are trading higher.

Currently, shares of Conatus Pharmaceuticals Inc (CNAT) are up near 90% at around $11.60, although well off a new record high of $14.17 hit earlier. GALT is up near 30% to around $10.90, but below a day high $11.38.

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Galectin Therapeutics Reports on Key 2013 Scientific, Development and Regulatory Milestones, Highlights Corporate and Financial Activity
BY GlobeNewswire — 8:00 AM ET 01/08/2014

NORCROSS, Ga.- Galectin Therapeutics Inc. (GALT) , the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today released a report on the Company's key scientific, development and regulatory milestones and corporate activity that contributed to the Company's progress in 2013.

Key activity in 2013 included:

Submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the Company's proprietary galectin inhibitor GR-MD-02 in fatty liver disease, and subsequent notification from the FDA to proceed with a Phase 1 clinical trial for GR-MD-02 in fatty liver disease with advanced fibrosis.
Receipt of Fast Track designation from the FDA for GR-MD-02 in fatty liver disease.
First patient enrolled in the first-in-man Phase 1 clinical trial for GR-MD-02 in fatty liver disease, currently taking place at six trial sites across the U.S.
Preclinical data showed the Company's galectin inhibitors may have therapeutic effect in diabetic kidney disease, contribute to reversal of cirrhosis and reduction of fibrosis, and significantly improve non-alcoholic steatohepatitis (NASH) activity.
Two executives were added to the Company's management team and several key investments occurred, including the exercise of common stock purchase warrants and a private placement of 500,000 shares of unregistered common stock.
"I am pleased to report that 2013 was a year of noteworthy progress for Galectin Therapeutics (GALT)," said Peter G. Traber, M.D., Chief Executive Officer, President and Chief Medical Officer, Galectin Therapeutics (GALT). "We believe strongly that galectin inhibitors hold immense promise for the treatment of fibrosis and inflammation, and the Company will continue to work diligently toward the ultimate goal of bringing a first-in-class treatment to the millions of Americans suffering from fatty liver disease with advanced fibrosis."

A summary of Galectin Therapeutics' (GALT) accomplishments in 2013 can be found on the Company's website at www.galectintherapeutics.com/GALT2013.

About Galectin Therapeutics (GALT Galectin Therapeutics (GALT) is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease and cancer based on the Company's unique understanding of galectin proteins, key mediators of biologic function. We are leveraging extensive scientific and development expertise as well as established relationships with external sources to achieve cost effective and efficient development. We are pursuing a clear development pathway to clinical enhancement and commercialization for our lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com.

Forward Looking Statements................

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Galectin Therapeutics Receives US Patent for Combination Treatment for Liver Fibrosis
BY GlobeNewswire — 8:00 AM ET 01/06/2014

NORCROSS, Ga., Jan. 6, 2014 (GLOBE NEWSWIRE) -- Galectin Therapeutics (GALT) , the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that it has received a notice of allowance from the U.S. Patent and Trademark Office for patent application number 13/550,962 titled "Galactose-Pronged Polysaccharides in a Formulation for Anti-fibrotic Therapies." The patent covers both composition claim for and uses of the Company's carbohydrate-based galectin inhibitor compound GR-MD-02 for use in patients with liver fibrosis in combination with other potential therapeutic agents. The patent covers use of GR-MD-02 with agents directed at multiple targets, some of which are currently in clinical development for fibrotic disorders including monoclonal antibodies to connective tissue growth factor, integrins, and TGF-ß1.

"This patent provides additional coverage in the U.S. for the use of GR-MD-02 in combination with other potential anti-fibrotic agents in the treatment of liver fibrosis," said Peter G. Traber, MD, President, CEO and CMO of Galectin Therapeutics (GALT). "In the future, liver fibrosis could be treated with a combination of agents, and this patent provides important intellectual property for this possibility. We are hopeful that our development program for GR-MD-02 will lead to the first therapy for the large unmet medical need of liver fibrosis."

Galectin Therapeutics (GALT) is currently conducting a Phase 1 clinical trial to evaluate the safety, tolerability and exploratory biomarkers for efficacy for single and multiple doses of GR-MD-02 over four weekly doses of GR-MD-02 treatment in patients with fatty liver disease with advanced fibrosis. In March 2013, the U.S. Food and Drug Administration (FDA) granted GR-MD-02 Fast Track designation for non-alcoholic steatohepatitis (NASH) with hepatic fibrosis, commonly known as fatty liver disease with advanced fibrosis.

About Fatty Liver Disease with Advanced Fibrosis

Non-alcoholic steatohepatitis (NASH), also known as fatty liver disease, has become a common disease of the liver with the rise in obesity rates, estimated to affect nine to 15 million people, including children, in the U.S. Fatty liver disease is characterized by the presence of fat in the liver along with inflammation and damage in people who drink little or no alcohol. Over time, patients with fatty liver disease can develop fibrosis, or scarring of the liver, and it is estimated that as many as three million individuals will develop cirrhosis, a severe liver disease where liver transplantation is the only current treatment available. Approximately 6,300 liver transplants are done on an annual basis in the U.S. There are no drug therapies approved for the treatment of liver fibrosis. FDA and AASLD (American Association for the Study of Liver Disease) recently held a 2-day workshop with leading scientific experts in NASH and key FDA officials to discuss acceptable regulatory endpoints for approval of drugs to treat NASH (http://www.aasld.org/additionalmeetings/Pages/aasldfdanash.aspx).