The Mesoblast limited (ASX: MSB) share price is up 1.6% at $3.15 in close of trade today. The company released its report this morning for the quarter ending 30 September, alongside an update on its lead product candidate remestemcel-L.
Mesoblast's gains today come as the S&P/ASX 200 Index (ASX: XJO) followed US and European markets lower, down 1.6% at close.
Mesoblast shareholders have endured some major ups and downs this year, with the share price cratering 64% from late January through to 23 March. Since that low, the share price is up 184%, for a year-to-date gain of 54%.
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What does Mesoblast do?
Mesoblast develops allogeneic cellular medicines. The company has established a portfolio of commercial products and late-stage product candidates via its proprietary mesenchymal lineage cell therapy technology platform.
Mesoblast's global intellectual property (IP) portfolio protection extends through to at least 2040 in all major markets. Its cell therapies are planned to be readily available to patients worldwide.
Why is the Mesoblast share price up today?
Investors appear to have taken note of the positive outlook Mesoblast reported for its lead product candidate remestemcel-L. This is intended to treat inflammatory diseases in children and adults, including severe acute respiratory distress syndrome.
The company noted that in September, the US Food and Drug Administration recommended it conduct another randomised study to prove the effectiveness of remestemcel-L.
Mesoblast said it now believes the product could receive accelerated approval as there are no other approved treatments for the life-threatening SR-aGVHD in children under 12. The company expects to meet with FDA officials in November to discuss the potential for accelerated approval, particularly as remestemcel-L could be used to treat respiratory distress associated with COVID-19.
Mesoblast chief executive Dr Silviu Itescu said:
We believe the immunomodulatory properties of remestemcel-L position this potential therapy at the forefront of treatment for severe and life-threatening inflammatory conditions, including COVID-19 acute respiratory distress syndrome (ARDS) and steroid-refractory acute graft versus host disease (SR-aGVHD).
We are pursuing an accelerated approval pathway for remestemcel-L in the treatment of children with SR-aGVHD, and a parallel approval pathway for COVID-19 ARDS if the randomised controlled Phase 3 trial is positive.
The company also reported cash on hand of US$108 million (AU$153 million). It stated it may have access to another US$67.5 million over the next 12 months through its existing financing facilities and strategic partnerships.
With the pandemic likely to see many more people suffering from respiratory issues, positive results from the Phase 3 trial could see Mesoblast's share price run far higher.
