Stem cell treatment maker Mesoblast's shares have plunged 30 per cent after the US Food and Drug Administration raised doubts about the effectiveness of the listed biotech's flagship product, which is being tested as a potential treatment for COVID-19.
Briefing materials released for the meeting on Tuesday from the FDA reveal it has tough questions for the company about the data it has produced to support its application for approval.Shares in Mesoblast finished down $1.51 or 31 per cent on Tuesday to $3.36.The regulator has posed questions about whether more evidence is needed to demonstrate the treatment delivers benefits to human patients.
The remestemcel-L treatment has been in development for two decades and the product has been tested in a range of clinical trials but has not resulted in a successfully approved product coming to market in the United States. The team at Bell Potter set a target price for the stock of $3.83 at the end of July, noting it was a speculative buy with the company set for significant benefits if the approvals process is succesful.
MsEmmaK It’s ODAC not FDA.
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