Mesoblast limited (ADR) (NASDAQ: MESO) is flying in the market this morning, and for good reason. The comapny announced key clinical data, supporting the submission of a New Drug Application with the United States Food and Drug Application (FDA). Of course, the news excited investors who are sending the stock screaming for the top. Today, we’ll talk about:
- The data;
- what we’re seeing from MESO as a result; and
- what we’ll be watching for ahead.
MESO Announces 100 Day Survival Data
As mentioned above, Mesoblast is having an incredibly strong start to the trading session this morning after the company provided data. In a press release issued early this morning, the company announced Key Day 100 survival outcomes from its Phase 3 clinical trial of remestemcel-L. Remestemcel-L is an allogenic mesenchymal stem cell product candidate. During the study, the company was assessing the use of the treatment in children with steroid refractory acute Graft Versus Host Disease (aGVHD). In the release, MESO said that the results are being presented today at the 2018 annual meeting of the International Society for Stem Cell Research (ISSCR).
During the Phase 3 clinical trial, 55 children with steroid-refractor aGVHD between ages tw months and 17 years were enrolled across 32 sites within the United States. 89% of the population in the study suffered from the most severe form of the condition, grade C/D aGVHD. Previously, MESO announced that the trial met the primary endpoint of 28 Day overall survival response rate. In the release, the company said that top line day 100 results demonstrated an 87% survival rate for Day 28 responders. Also, the overall survival rate as of Day 100 was 75%. Finally, the company said that the multi-infusion regimen of remestemcel-L was well tolerated.
With the strong data in mind, and based on previous interactions with the FDA, Mesoblast said that it believes that these successful results, together with Day 180 safety, survival and quality of life perameters, may provide sufficient evidence to file for accelerated approval of remestemcel-L in the United States. Currently, there are no approved treatments for steroid-refractory aGVD, making this a potentially tremendous market opportunity. In a statement, Dr. Silviu Itescu, CEO at MESO, had the following to offer:
It is wonderful to see that our unique cellular therapy has shown such promising survival rates at Day 100 in children suffering from this devastating disease. Our objective is to bring this new therapy to market, and make it available to patients who are in desperate need with this life-threatening complication of an allogeneic bone marrow transplant.
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 cuases moves. In the case of MESO, the news proved to be overwhelmingly positive. With the strong data in mind, the company is well on its way to potentially acheiving accelerated approval. So, it’s no surprise to see that the stock is screaming for the top as excited investors push. Of course, our partners at Trade Ideas were the first to alert to the gains. Currently (9:51), MESO is trading at $6.30 per share after a gain of $0.76 per share or 13.72% 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 MESO. In particular, we’ll be following the news surrounding the company’s contined work to bring remestemcel-L to market. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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