Alliance Partners

Thursday, November 14, 2024

Mesoblast is looking to get FDA approval for Ryonci!





This is pretty exciting !! 
I have recently  invested in Mesoblast (AsX :MSB) - after listening to a great panel discussion with Sarah Murdoch and 3 panelists talking about how medicine is going to change over the next 5 years with the development and x fertilisation of stem, crispr and  AI .

This is what made me invest:- 

Cell therapy company Mesoblast (ASX:MSB) has entered into a convertible note subscription agreement with its largest shareholder, Gregory George, to issue up to US$50 million convertible notes at its discretion.


The issue of the convertible notes is linked to the US

FDA's approval of Mesoblast's lead product candidate, Ryonci (remestemcel-L), for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGHD).


The company said the funding will enable it to implement its go-to-market commercial strategy.It said it expects a decision before or on the FDA's Prescription Drug User Fee Act goal date of 7 January, 2025.


Mesoblast chief executive Silviu Itescu said: "We appreciate the ongoing support from our major shareholder in ensuring that the Company is well capitalised for commercial product launch and can hit the ground running immediately following approval of RYONCIL by FDA."


Mesoblast chief executive Silviu Itescu said: "We appreciate the ongoing support from our major shareholder in ensuring that the Company is well capitalised for commercial product launch and can hit the ground running immediately following approval of RYONCIL by FDA."

Mesoblast said its go-to-market strategy includes hiring senior executives, market access, medical education, and ongoing engagement with key opinion leaders.




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