Australian cellular medicine company, Mesoblast (ASX:MSB) has presented at the Biotech showcase in San Francisco flagging potential FDA approval and the US launch of its lead product candidate Ryoncil.
The final module of the rolling Biologics License Application for Ryoncil will be filed with the FDA in January, following which the Company will request a priority FDA review of the application under the product candidate’s existing fast track designation.
Mesoblast together with its strategic partners is also looking forward to readouts of Phase 3 trials for its product candidates in advanced chronic heart failure and chronic low back pain due to degenerative disc disease
The company also highlighted the continued growth in revenues from royalties on sales in Japan of the related product TEMCELL®1 for acute graft versus host disease.
Shares in Mesoblast (ASX:MSB) are trading 0.2 per cent higher to $2.31.