Mesoblast Share Price Up on FDA ‘Fast Track’ Designation (ASX:MSB)

At time of writing the Mesoblast Ltd [ASX:MSB] share price is up 7.26%. Soaring on the back of some exciting news.

Their remestemcel-L treatment — which we previously discussed here — has secured ‘fast track’ status from the US Food & Drug Administration (FDA). A designation that could hint towards a promising result for their Phase III trial…

More importantly, it could also bode well for tackling the ongoing COVID-19 pandemic.

Finding a remedy for acute respiratory distress syndrome (ARDS)

No doubt, the key point that is getting the market excited today is the fact that this drug is a treatment for ARDS. The life-threatening disease at the heart of the COVID-19 pandemic.

So far, remestemcel-L has proved quite effective against ARDS. Holding up under both phase I and II trials. With the ongoing Phase III trial also progressing as we speak. Though any data from this final trial is still yet to be revealed.

However, all the evidence to date suggests it should be effective. Which is precisely why the FDA has likely fast-tracked the drug’s development. As Mesoblast notes:

Clinical data provided to the FDA supporting the potential of remestemcel-L to address the unmet medical need of COVID-19 ARDS included resuults from a pilot study of remestemcel-L under emergency compassionate use at New York’s Mt Sinai Hospital in March-April this year.

In this study, nine of 12 ventilartor-dependent patients (75%) with moderate to severe COVID-19 ARDS were successfully dischard from hospital a median of 10 days after receiving two intravenous doses of remestemcel-L.

While these results are by no means conclusive on their own, they do underscore the potential. Highlighting just how important this drug could wind up being.

For that reason, investors have plenty of cause to be optimistic about the drug and Mesoblast’s performance. Albeit, with the caveat that there are never any guarantees when it comes to biotech stocks.

What’s next for the Mesoblast share price?

As I’ve already noted, the ongoing Phase III trial is still the focus for this company.

Only once we start seeing some early data and the results can we come to any conclusion. But in the meantime, Mesoblast is working hard to ensure this drug is a winner.

They certainly aren’t the only one though. With a handful of drug companies all inching closer to cracking the COVID-19 problem. Each of which could make a hefty profit if they find the right solution.

For investors, it is a risky market to dabble in, but the rewards could be huge.

If you’re willing to bear that risk, then the time to try your luck with biotechs may be now.


Ryan Clarkson-Ledward,
For Money Morning

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Ryan Clarkson-Ledward is an Editor at Money Morning.

Ryan holds degrees in both communication and international business. He helps bring Money Morning readers the latest market updates, both locally and abroad. Ryan tackles all the issues investors need to know about that the mainstream media neglects.

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