Mesoblast is hoping its flagship product remestemcel-L will be shown to relieve acute respiratory distress syndrome (ARDS) in COVID-19 patients. The company is running a phase 3 trial of the product in US hospitals, but the research is still in its early stages, with a pilot study of the project looking at only 12 patients.

The US Data Safety Monitoring board, which reviews clinical data, had selected a date in early September to complete an initial review of Mesoblast's phase 3 trial, the company said. There are no approved treatments for this kind of respiratory distress, and it is not yet known whether its product will prove safe and effective in a large group of patients.

Dr Itescu said the company would know the results by the end of this calendar year. If the project is successful, the product could be manufactured in Australia for export into global markets to treat COVID patients around the world.

"We're tracking pretty much as expected," Dr Itescu said.

The company has also been working on getting the same product approved in the US for use in children who have graft-vs-host disease, a complication from bone marrow transplants.

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The Food and Drug Administration will review data about the effectiveness of the treatment on August 13. Dr Itescu said the regulator would advise whether the product has received approval before September 30.

Reviews of these two projects could have large implications for Mesoblast's future.

The company, which has been backed by high-profile investors including billionaire Alex Waislitz, has seen its shares turbocharged by updates on its COVID research in recent months. They jumped more than 5 per cent again on Thursday, trading at $3.84 by mid-afternoon.

The business generated $US2.1 million from customers in the June quarter and had $19.6 million in operating expenses.

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Mesoblast sees lasting need for COVID treatment beyond a vaccine - Sydney Morning Herald