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Mesoblast Limited

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US Food and Drug Administration issued a “complete response letter” to Mesoblast in October 2020, asking for more data on its treatment before it could be approved in the US market.

Mesoblast shares tank after US FDA delays stem cell approval again

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.

  • Emma Koehn and Jessica Yun
Mesoblast shares suffered another tumble on Tuesday on news that Novartis was walking away from the deal.

‘Heads down and working’: Mesoblast boss unfazed as Novartis deal ends

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.

  • Emma Koehn
Mesoblast shares dropped 12 per cent at Tuesday’s open.

Mesoblast reveals more COVID trials needed, shares tumble

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.

  • Emma Koehn
Mesoblast derives stem cells from bone marrow, and uses mesenchymal adult stem cells to assist the body’s repair and regenerative process.

‘There’s always a way forward’: Crunchtime for Mesoblast as legal threats loom

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.

  • Emma Koehn
Mesoblast chief executive and major shareholder Silviu Itescu is back in front of potential investors.

Troubled Mesoblast secures crucial cash buffer from surprise US backer

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.

  • Emma Koehn
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Mesoblast shares have been on a rollercoaster the past six months but the company is yet to get US regulatory approvals.

Investors in drugmaker Mesoblast sweat on crucial capital raising

The stem cell giant says it needs cash from its existing partnerships to ‘continue as a going concern’.

  • Emma Koehn
Mesoblast scored a big regulatory win this morning.

Mesoblast shares savaged on poor trial results for COVID treatment

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.

  • Emma Koehn
Mesoblast chief executive Dr Silviu Itescu.

Mesoblast stumbles as FDA demands more evidence of drug effectiveness

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.

  • Emma Koehn
Dr Silviu Itescu, chief executive of stem cell company Mesoblast.

Mesoblast revenue jumps ahead of critical month

The stem cell treatments provider is bracing for a critical month of news that will determine the future of its flagship products.

  • Emma Koehn

Original URL: https://www.brisbanetimes.com.au/topic/msb-zp