World News – AU – Why Mesoblast (ASX: MSB) stock is down 11%

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The Motley Fool Australia Stock Market News Why Mesoblast (ASX: MSB) Is Down 11%

James Mickleboro | 15th. December 2020, 10:18 am | More on: MSB

Mesoblast Limited (ASX: MSB) stock price came under pressure Tuesday following the release of an announcement.

At the time of writing, allogeneic cellular drug developers’ stakes have dropped 11% to $ 4. 03.

This morning, Mesoblast announced key findings from DREAM-HF’s landmark Phase 3 randomized controlled trial of its allogeneic cell therapy Rexlemestrocel-L (REVASCOR) in 537 patients with advanced chronic heart failure.

According to the press release, patients with advanced chronic heart failure who received a single endomyocardial treatment with Rexlemestrocel-L in addition to maximal therapies had a 60% reduction in the frequency of heart attacks or strokes and a 60% reduction after a 30-month follow-up period ig reduction in death from cardiac causes when treated earlier in the disease’s progression.

Despite this reduction in the default endpoint of cardiac death, there was no reduction in recurrent non-fatal decompensated heart failure events. This was the primary endpoint of the study.

Management believes that this suggests that Rexlemestrocel-L lowers mortality through mechanisms different from existing drugs that lower hospital stay rates but do not significantly affect cardiac mortality.

Dr. Silviu Itescu, Chief Executive of Mesoblast, commented: “There is an urgent need for new therapies that can reduce the high mortality rates in patients with heart failure through different mechanisms of action of existing drugs that lower hospital stay rates but have not significantly reduced death rates. ”

« The mortality reduction observed with Rexlemestrocel-L in advanced chronic heart failure underscores the power of this technology and Mesoblast’s commitment to treating diseases in patients with high unmet needs that are inadequate over existing therapies, » he added.

Although the primary endpoint may not have been met, management still sees potential for therapy.

Dr. Fred Grossman, Mesoblast’s Chief Medical Officer, stated, “We believe that the mortality benefit seen in this landmark Phase 3 study will support a potential avenue for approval of Rexlemestrocel-L in patients with advanced chronic heart failure. We plan to discuss possible avenues for approval based on mortality reduction with the US Food and Drug Administration. ”

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James Mickleboro, a contributor to the Motley Fool, has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). . Authorized by Bruce Jackson.

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Mesoblast, Heart Failure, ASX: MSB, Cell Therapy, ASX, Myocardial Infarction