Lately biopharma stocks like Galectin Therapeutics Inc (NASDAQ:GALT) have been seeing tremendous upside. Maybe it’s due to the new administration the stock market has been kind to stocks that have their hand in therapeutics or healthcare related markets. Whatever the case may be we here at Street Register make it our mission to find the hottest trends and identify undervalued opportunities in those areas for our readers.
In the beginning of November right before the elections Galectin Therapeutics Inc (NASDAQ:GALT) was trading at its 52-week low of .49. Just this week GALT stock touched a new three month high of $1.42. A whopping 190% gain to be had in the last three months. There is a significant gap on the chart from September between $1.59-2.30’s. If GALT can retrace to those levels filling the gap or even better return to its yearly high of $3.05 we could see another 84-144% in gains from its current price of $1.25.
NORCROSS, Ga., Feb. 01, 2017 (GLOBE NEWSWIRE) — Galectin Therapeutics Inc (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced it has generated sufficient financing to cover currently planned expenditures through 2017 and it remains on track to present top line data from its NASH-CX Phase 2 clinical trial by early December 2017.
Through the sale of common stock via the Company’s At-The Market sales agreement, and previously announced private placements in September and December 2016, the Company has reached a financing milestone and believes it now has sufficient funding to cover currently planned expenditures through 2017, most notably its NASH-CX trial.
Additionally, the Company has reached important clinical milestones in its NASH-CX trial, a double blind, placebo-controlled Phase 2b clinical trial which has enrolled 162 NASH cirrhosis patients into the treatment phase. To date, 47 patients have completed all 52 weeks of infusions with the company’s lead compound, GR-MD-02, and 122 patients have completed 26 weeks of infusions. In the NASH-CX clinical trial, more than 3,000 infusions (or 75% of the maximum infusions in the trial) have been administered with no drug-related serious adverse reactions. Only 8 patients have discontinued participation in the clinical trial before their scheduled completion dates, and none of the discontinuations were due to drug-related serious adverse events. Currently, the approximate 5% dropout rate is significantly below the 25% included as part of the trial design. The top-line data readout of the NASH-CX trial remains on track for early December 2017.
“NASH cirrhosis represents a large unmet medical need with no currently approved therapies, and we are very pleased with our progress in the NASH-CX trial,” said Dr. Peter Traber, President, Chief Executive Officer and Chief Medical Officer of Galectin Therapeutics. “A drug that can halt progression of, or reverse existing fibrosis, in NASH cirrhosis patients would be a breakthrough therapeutic intervention that may prevent complications, alleviate the need for liver transplant, and even prevent death.
“The NASH-CX trial is designed to assess the efficacy of our lead compound, GR-MD-02, in patients with NASH cirrhosis. The trial is being conducted with a primary endpoint that the U.S. Food and Drug Administration views may be a surrogate for outcomes for registration trials in this patient population,” added Dr. Traber. “As previously disclosed, the significant biological activity of GR-MD-02 in humans has been demonstrated in patients with moderate to severe plaque psoriasis, a disease which occurs with increased frequency in patients with NASH.” (See press release.)
In the NASH-CX trial, NASH-cirrhosis was confirmed both by liver biopsy and by confirmation of an elevated hepatic venous pressure gradient (HVPG). Enrolled patients are receiving either 8 mg/kg or 2 mg/kg of GR-MD-02 or placebo every other week for 52 weeks, for a total of 26 doses. The primary study endpoint is a reduction in HVPG. Patients treated with GR-MD-02 will be evaluated to determine the change in HVPG as compared to patients treated with placebo. The importance of portal hypertension as measured by HVPG as a potential regulatory endpoint for cirrhosis trials has been discussed in a CEO Perspective. Secondary end-points include NASH fibrosis stage and percent of fibrotic tissue based on liver biopsy and other non-invasive measures including FibroScan and 13C Methacetin breath test (see: www.clinicaltrials.gov for further details).
GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. The drug binds to galectin proteins and disrupts their function. Preclinical data in animals have shown that GR-MD-02 has robust treatment effects in reversing liver fibrosis and cirrhosis.
About Galectin Therapeutics
Galectin Therapeutics 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, which are key mediators of biologic function. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. The Company is pursuing a development pathway to clinical enhancement and commercialization for its lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com.
Currently trading at a $37 million dollar market cap with over 29 million shares outstanding, in our opinion, GALT could still be undervalued. What could happen to GALT when president-elect Trump starts making the policy changes he’s discussed? Be sure to be subscribed to the Streetregister.com newsletter, as the story unfolds on GALT we will report back to our members on any new developments. Stay up to date as the situation of GALT develops by subscribing to our newsletter, just enter your email in the subscribe box below! Sign up now.