Mesoblast Limited ($MESO) reported that the United States Food and Drug Administration (FDA) has granted a Fast Track designation for the use of its cell therapy, MSC-100-IV. The treatment is designed to achieve improved overall response rate in children with steroid refractory acute Graft Versus Host Disease (aGVHD). The designation helps in shortening the time to FDA approval through priority review. It also helps in streamlining rolling review process.
The company stock has gained 43 percent this year so far while its 12 months loss is now down to a little over 6 percent. The stock is expected to keep up its upward trajectory on the back of its latest achievement.
Mesoblast recently reported its half yearly results. The company announced that it has prioritized its pipeline to focus its resources on four Tier 1 product candidates with nearest-term revenue opportunities and/or potential blockbuster target markets. At December 31, 2016, the Group had cash reserves of US$55.6 million after adjusting for the committed capital of US$21.7 million from the equity purchase agreement with Mallinckrodt Pharmaceuticals announced on December 23, 2016
Mesoblast reported that it achieved considerable savings in expenses by reducing its commercial manufacturing, labor costs within R&D and management & administration expenses.