Galmed Pharmaceuticals Ltd (NASDAQ: GLMD) is having an overwhelmingly strong start to the trading session this morning, and for good reason. It looks as though the company has reached a key milestone in the treatment of non-alcoholic steatohepatitis (NASH) in a clinical trial. Of course, the news excited investors, sending the stock screaming for the top. Today, we’ll talk about:
- The data;
- what we’re seeing from GLMD as a result; and
- what we’ll be watching for with regard to the stock ahead.
GLMD Heads For The Top On Clinical Results
As mentioned above, Galmed Pharmaceuticals is having an incredibly strong start to the trading session this morning after the company released clinical data. In a press release issued early this morning, the company announced top-line, 52 week results from the global Phase 2b ARREST study. During the study, patients underwent MRS and biopsy at baseline and week 52. The data was centrally read and blinded to treatment allocation.
In the release, GLMD said that the primary endpoint of the study was change from baseline to end of study in liver triglycerides ratio as measured by MRS. Secondary endpoints included fibrosis improvement by at least one stage or more without worsening of NASH and NASH resolution or worsening fibrosis. Other secondary endpoints included improvement in NASH activity index, without worsening fibrosis and change in baseline to week 52/termination in ALT (U/L). Finally, Serious Adverse Events were reported in 12.5%, 8.9% and 9.2% of patients in placebo, Aramchol 400mg and 600mg arms respectively. Also, no clustering of event type or atypical events for the studied population were reported in either of the Aramchol arms suggesting a strong tolerability profile. In a statement, Allen Baharaff President and CEO at GLMD, had the following to offer:
We are excited with the ARREST results that will enable Galmed to meet with the regulators as soon as possible and discuss the pivotal study design… It is extremely gratifying that Aramchol’s scientific rationale for disease modification of NASH is being translated into clinical coherent results.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news causes moves. In the case of Galmed Pharmaceuticals, the news proved to be overwhelmingly positive. With the strong data that was released, the company is now one step closer to reaching regulatory approval and becoming a company in the commercial, revenue generating stage. So, it’s no surprise that excited investors are sending the stock upward in the market this morning. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:13), GLMD is trading at $19.98 per share after a gain of $12.93 or 183.40% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on GLMD. In particular, we’re interested in following the ongoing work surrounding Aramchol and excited to see the future results as the treatment seems to be showing some promise. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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