The US regulator has again asked for more data on the stem cell treatment maker’s flagship product,which was blocked from approval in 2020 for the same reason.
Stem cell treatments maker Mesoblast’s shares have taken a hit after the company said its $US50 million partnership with biotech giant Novartis has fizzled out.
The Melbourne biotech has been advised by the US medicines regulator that it will need to run another trial of its COVID-19 treatment before it can apply for emergency approvals.
Investors in the ambitious biotech have been on a rollercoaster ride for years,but 2021 sees it fighting for validation and fighting off class action lawsuits after a year of smashed hopes.
Troubled drug developer Mesoblast has been given a financial lifeline analysts expect will give it an 18-month cash buffer after securing a $138 million investment from a surprise US backer.
The stem cell giant says it needs cash from its existing partnerships to ‘continue as a going concern’.
The stem cell biotech has had its share price smashed after the company emerged from a trading halt to reveal its COVID-19 treatment trial was unlikely to meet its primary goal.
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 stem cell treatments provider is bracing for a critical month of news that will determine the future of its flagship products.
The drug that Mesoblast has been trialling on some COVID-19 patients has just got the nod from a US regulatory panel for treating children with severe responses to bone marrow transplants.
The stem cell treatment maker is under pressure as it faces a crucial test to get its flagship drug approved by the US Food and Drug Administration.