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Dual Nasdaq-listed Mesoblast (ASX:MSB) shares have fallen ~7% today after announcing completion of a global private placement primarily to its existing major US, UK, and Australian shareholders, raising $260 million at $2.50 per share – an 11% discount to where its share price last traded.

The placement follows Mesoblast achieving US Food and Drug Administration (FDA) approval in December for its cell therapy remestemcel-L to treat paediatric graft-versus-host disease (GvHD).

Approval of remestemcel-L (branded Ryonocil) was a big deal for Mesoblast, with the US regulator previously rejecting treatment in 2020 and again in 2023, significantly delaying its commercial launch.

Mesoblast said proceeds from the placement would be used for clinical development, expansion of commercial manufacturing activities in preparation for product uptake and demand along with working capital and general corporate purposes.

“We appreciate the strong support from our shareholders as we scale up production and provide to hospitals Ryoncil, the first and only FDA-approved mesenchymal stromal cell therapeutic, to treat children with life-threatening SR-aGvHD,” CEO Dr Silviu Itescu said.

Upon approval of remestemcel-L, Itescu said the company would continue to work closely with FDA to obtain approval of other late-stage products, including Revascor (rexlemestrocel-L), for cardiovascular diseases and inflammatory pain indications.