Mesoblast Limited (NASDAQ: MESO) was in the green on Friday, and closed the day with gains of 13%. This came after the company did a presentation for its commercial plans at the 2020 biotech show in San Francisco. In the presentation, the company announced that, the FDA had agreed to the choice of Ryoncil as the commercial name for its allogenic cell therapy treatment of AGVHD (Acute Graft Versus Host Disease).
While doing the presentation, the CEO Silviu Itescu stated that, the company was starting the year 2020 with excitement as they awaited approval by the FDA for Ryoncil as a treatment for AGVHD, a dangerous complication in bone marrow transplant. He further stated that, its revenues from royalties coming from sales in Japan of TEMCELL (A closely related product for treating AGVHD) gave insights on the potential of Ryoncil in the United States.
On top of that, the CEO stated that the company was working with its strategic partners for readouts on phase 3 trial of its lead product candidates in chronic low back pain and chronic heart failure, caused by degenerative disc disease.
In the presentation, the company also noted that in the course of the month, it will fill the first module of the rolling biologics license application for Ryoncil. It will then seek priority review by the FDA for BLA under the current fast track designation for its product candidate. It further announced that, if Ryoncil gets approved, it will be launched in the U.S market this year.
From a look at its price action, the stock surged higher in Friday’s session. It opened the day at $8.44 and traded between a low of $8.44 and a high of $10.39 before closing the day at $9.39. Volumes in the day stood at 402.74k.
About Mesoblast Limited
Mesoblast Limited is a Biopharma Company that focuses on the development of allogenic cellular medicines. The company is based in Melbourne, Australia.