Madrigal Pharmaceuticals Inc (NASDAQ: MDGL) is having an overwhelmingly strong day in the market today, gaining in multiples, rather than percentages. Ultimately, the gains are the result of positive data released by the company surrounding a Phase 2 clinical trial. Of course, the data was positive, leading to excitement among investors and sending the stock screaming for the top. Today, we’ll talk about:
- The data;
- what we’re seeing from the stock as a result; and
- what we’ll be watching for with regard to MDGL ahead.
MDGL Announces Clinical Data
As mentioned above, Madrigal Pharmaceuticals is having an overwhelmingly strong day in the market today after the company announced positive data. In a press release issued early this morning, the company announced positive top-line, 36-week results from a Phase 2 clinical trial surrounding patients with biopsy-proven non-alcoholic steatohepatitis (NASH).
In the release, MDGL said that MGL-3196 demonstrated statistical significance in the primary endpoint during the trial, which was the relative reduction of liver fat on magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF) at 12 weeks. The company also saw statistically significant results in multiple Week 36 endpoints including key secondary endpoints such as the reduction and resolution of NASH. Not to mention, the data showed that the treatment was both safe and tolerable among the patient population. In a statement, Dr. Stephen Harrison, M.D., Principal Investigator of the study, had the following to offer:
NASH is a common liver disease in the United States, with a growing prevalence, for which no FDA approved treatment is yet available… Compared with Week 12, at Week 36 MGL-3196 showed sustained effects to reduce liver fat on MRI-PDFF, and more reduction in liver enzymes than placebo. MGL-3196 demonstrates improvement relative to placebo on measurements of NASH on liver biopsy, including resolution of NASH. Importantly, this study is the first to demonstrate a correlation between efficacy in a non-invasive imaging test, MRI-PDFF at 12 weeks, and improvement in NASH on liver biopsy at 36 weeks.
The above statement was followed up by Paul Friedman, M.D., CEO at MDGL. Here’s what he had to offer:
The degree of NASH resolution, an approvable FDA endpoint, in patients who received MGL-3196 for 9 months we believe suggests a high likelihood of success in a larger trial with a somewhat longer treatment period in a Phase 3 study designed similarly to this Phase 2 study, pending regulatory agreement with such a design. Further, considering what we have learned regarding drug exposure and dosing, we believe there is potential to resolve NASH in as little as 9 months in 30-40% of patients receiving only MGL-3196, a well-tolerated once a day oral therapy.
Finally, Becky Taub, M.D., CMO and Executive VP of Research and Development at MDGL, had the following to offer:
We are excited by the results of this study that demonstrate that MGL-3196 has the potential to show a clear benefit in patients with NASH, including both reduction and resolution of NASH and improvement in multiple atherogenic lipids. Cardiovascular disease is the primary reason for death in patients with NASH. We look forward to advancing MGL-3196 in a Phase 3 clinical trial in patients with NASH.
What We’re Seeing From The Stock
As investors, one of the first lessons that we learn is that the news moves the market. When it comes to Madrigal Pharmaceuticals, the news proved to be overwhelmingly positive. With the strong data in mind, the company is close to bringing this important, and overwhelmingly valuable treatment to the market. So, it’s no surprise that excited investors are reacting in a positive way. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (10:57), MDGL is trading at $244.68 per share after a gain of $136.25 per share (125.66%) 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 MDGL. In particular, we’re interested in following the story surrounding MGL-3196 and the Phase 3 clinical trial that’s just around the corner. Nonetheless, we’ll continue to follow the news closely and bring it to you as it breaks!
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