Mesoblast Ltd [ASX: MSB] stocks suffered a severe blow today due to the results of phase three of chronic heart failure -L Therapy.
Mesoblast stock’s price has done reasonably well this year, despite having experienced significant volatility over the past three months.
MSB fell ~ 41% in early October due to a setback to its Biologics license application, but quickly made up for the loss in November due to solid quarterly results and a collaboration agreement with Novartis.
At the time of writing, MSB stock is down 12. 34% or 54 cents to trade at $ 3. 98 per share.
Today MSB announced results from the randomized controlled DREAM-HF phase 3 study of its allogeneic cell therapy Rexlemestrocel-L in 537 patients with advanced chronic heart failure.
During an average follow-up period of 30 months, patients with advanced chronic heart failure who received treatment with Rexlemestrocel-L in addition to maximal therapies saw a 60% reduction in the frequency of heart attacks or strokes.
There was also a 60% reduction in death from cardiac causes when treated earlier in the disease progression, according to MSB.
The reason for the drop in prices could be that the therapy is ineffective in limiting recurring non-fatal heart failure events, which was the study’s primary endpoint.
This means that Rexlemestrocel-L lowers mortality through mechanisms different from existing drugs that lower hospital stay rates but do not significantly affect cardiac mortality.
“There is an urgent need for new therapies that can lower high death rates in patients with heart failure through mechanisms of action different from existing drugs that lower hospital stay rates but do not significantly lower 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 unresponsive disease in patients with high unmet needs that are unresponsive to existing therapies. ‘
According to MSB, there is a lot of positive evidence emerging from today’s results, which means that the therapy can still be used commercially in the treatment of heart failure.
« The study results show that Rexlemestrocel-L, when used early, significantly reduces cardiovascular mortality in patients with heart failure who are at risk of disease progression and provides permanent protection against heart attacks or strokes in those at risk patients. ‘
MSB believes that the observed benefits of the study will support a potential avenue for approval of Rexlemestrocel-L in patients with advanced chronic heart failure.
The company also plans to meet with the US Food and Drug Administration (FDA) to discuss possible avenues for approval based on mortality reduction.
In terms of its stock price, we saw that MSB’s stock price rebounded as quickly as it fell during moments of this year.
Should rexlemestrocel-L get FDA approval to move further, we could see a nice surge in MSB’s share price.
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Lachlann Tierney is an analyst for Money Morning and has been investing for almost a decade. With a Master of Science degree from the London School of Economics, he brings a thorough understanding of global markets to his writing. Lachlann is interested in new technologies, energy solutions and helps people to invest their money wisely. He recently worked with Ryan Dinse. Lachlann is involved in two publications:
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Mesoblast, ASX: MSB, ASX, Heart Failure, Cell Therapy
World News – AU – Mesoblast stock price crashes on results of heart failure therapy
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