based on a November 2025 presentation, Mesoblast plans to file...

based on a November 2025 presentation,

Mesoblast plans to file an Investigational New Drug (IND) application in Q1 2026 for a label expansion targeting biologic-refractory inflammatory colitis


@Pledge

Relax, I hate to be the bearer of good news, but maybe you should start researching recombinant growth factors which can improve existing expansion yields fivefold !

Consider what CMC procedures a Company like Mesoblast would have to undertake to ensure their CDMO manufacturing facility is GMP compliant before filling a IND application….then work backwards with your timelines….and voila… Mesoblast must have a US contract manufacturing facility about to undergo final internal auditing before INDs are submitted !

I believe it is self evident that Mesoblast is just months away from completing the latter task, based on the filing dates already given to markets.

The exceptionally high reference pricing achieved by Ryoncil for sr aGVHD combined with the superior potency and process enhancements made, should mean that 3D bioreactor production can probably be left on ice for now ..until after approval. I anticipate gross margins of close to 90% on most therapies post utilising these growth factors without using new 3D reactors…even in adult populations requiring treble the mean weight based dose .

When the market finally wakes up to the near term profit potential of this Company, I believe that share price will go ballistic.
Many people have overlooked the profitability of GVHD as a stand alone indication for this Company (even based on current declared quarterly run rates) largely because of all the growth capex being spent on other indications. Nuts !


Roll on the middle of Decemeber for the CLBP Type B meeting on CLBP and opioid cessation ! OP

Please do not rely on the facts and opinions expressed in the above post when making an investment decision.