Mesoblast Ltd [ASX:MSB] shares have taken a heavy hit today on the back of phase three chronic heart failure results for its rexlemestrocel-L therapy.
The Mesoblast share price has tracked fairly well this year, although its has experienced significant amounts of volatility in the past three months.
Source: TradingView
MSB plummeted ~41% in early October on a setback for its Biologics License Application but quickly made up for the loss in November on solid quarterly results and a collaboration agreement with Novartis.
At the time of writing, the MSB share price is down 12.34%, or 54 cents, to trade at $3.98 per share.
What’s happened?
Today, MSB announced results from the DREAM-HF phase three randomised controlled trial of its allogeneic cell therapy rexlemestrocel-L in 537 patients with advanced chronic heart failure.
Over a mean 30 months of follow-up, patients with advanced chronic heart failure, who received a treatment of rexlemestrocel-L on top of maximal therapies, saw a 60% reduction in incidence of heart attacks or strokes.
According to MSB, there was also a 60% reduction in death from cardiac causes when treated at an earlier stage in the progressive disease process.
Sounds like good news, right?
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The reason for the share price slump could be due to the therapy not being effective in limiting recurrent non-fatal heart failure events, which was the trial’s primary endpoint.
Meaning that rexlemestrocel-L reduces mortality by mechanisms that are distinct from those of existing drugs, which reduce hospitalisation rates but do not significantly impact cardiac mortality.
Mesoblast CEO Dr Silviu Itescu commented on the results:
‘There is an urgent need for new therapies that can reduce the high death rates in heart failure patients by different modes of action from existing drugs which reduce hospitalization rates but have not significantly reduced mortality rates.
‘The reduction in mortality seen with rexlemestrocel-L in advanced chronic heart failure underlines the power of this technology and the commitment of Mesoblast to address diseases in patients with high unmet need which are refractory to existing therapies.’
What does this mean for the Mesoblast share price?
According to MSB, there are plenty of positive notes to pull from today’s results, meaning there is still potential commercial use for the therapy in treating cardiac failure.
The trial’s co-principal investigator, Dr Emerson Perin, said:
‘The trial results show that rexlemestrocel-L significantly reduces cardiovascular mortality when used early in heart failure patients at risk of disease progression, and provides durable protection from heart attacks or strokes in these vulnerable patients.’
MSB believes that the observed benefits from the trial will support a potential path for approval of rexlemestrocel-L in patients with advanced chronic heart failure.
The company is also planning to meet with the US Food and Drug Administration (FDA) to discuss potential pathways to approval based on mortality reduction.
In terms of the share price, we have seen MSB’s share price bounce back just as rapidly as it fell in moments this year.
Should rexlemestrocel-L be allowed by the FDA to progress further, we could see a nice bump in the MSB share price.
Regards,
Lachlann Tierney,
For Money Morning
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