Mesoblast Limited (NASDAQ:MESO) Receives A Favorable Response From The Advisory Committee Of FDA For RYONCIL To Treat Children With Steroid Refractory aGVHD

Mesoblast Limited (NASDAQ:MESO) received an overwhelmingly positive vote from the US FDA’s advisory committee endorsing the efficacy of its lead drug – Ryoncil.

Launch of Ryoncil in Q4 2020

Ryoncil (remestemcel-L) will be used to cure children suffering from steroid-refractory aGVHD (acute graft versus host disease).  Dr. Silviu Itescu, Chief Executive of Mesoblast, said the company is closely working with FDA for an approval action date in September 2020. The company is making commercialization preparations and plans to introduce the drug in Q4 2020.

Positions Ryoncil to treat coronavirus in adults and children

Mesoblast also positioned Ryoncil to treat inflammatory complications in adults and children suffering from COVID-19, considering its anti-inflammatory effects in aGVHD. The company is continuing to enroll adults suffering from acute respiratory distress syndrome in Phase 3 clinical trial of Ryoncil, targeting to reduce the chief cause of mortality because of coronavirus infection.

Availability of Ryoncil

Mesoblast already ensured the availability of Ryoncil to treat children with MIS-C and suffering coronavirus infection under its EAP (Extended Access Program).

Silviu said the company awaits the results of its lead drug candidate – Ryoncil, in Phase 3 clinical trial for discogenic low back pain and chronic advanced heart failure and treatment of coronavirus infection.

Enhanced demand for Ryoncil in the US

Mesoblast expects significant demand for Ryoncil in the US to treat children and adults with SR-aGVHD. The US demand will be eight times higher for this drug than Japan given the incidence of aGVHD and difference in the size of the population.

Mesoblast augmented its strategic execution and commercial capabilities by adding Dagmar Rosa-Bjorkeson as COO. Dagmar brings over 25 years of experience worldwide in the pharmaceutical industry that comprises leadership roles in market development, operational execution, and corporate strategy.

Mesoblast posted a growth of 92% YoY to $32.2 million in 2020. It reported a growth of 127% to $25 million in revenues from strategic partnerships in 2020. It also achieved an increase of 32% in royalty revenues from the sale of TEMCELL® HS Injection in Japan to $6.6 million. Mesoblast also narrowed the loss by 13% to $77.9 million in 2020.

The Ethics Committee in Australia allowed including Australian hospitals in Phase 3 clinical trial of Ryocin to cure coronavirus patients who are ventilator dependent with ARDS.