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Mesoblast stumbles as FDA demands more evidence of drug effectiveness – Sydney Morning Herald
The listed biotech’s push to get its flagship product approved in the US has suffered a setback, as the US regulator asks for more evidence of its effectiveness…
The biotech, valued at $1.9 billion, has been striving for a decade to get remestemcel-L approved in the US market. It is also trialling the same product for treatment of coronavirus, in cases where patients are experiencing severe respiratory distress.
The prospect of the coronavirus treatment has sent shares rallying in recent months. In April, Mesoblast shares were sitting at $1.46 but were at $5.08 before going into the trading halt this week.
Chief executive Silviu Itescu said he believed…
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