Mesoblast Says Ryoncil Receives FDA Approval for Acute Graft Versus Host Disease; Shares Rise Pre-Bell

MT Newswires Live12-19

Mesoblast (MESO) said late Wednesday the US Food and Drug Administration has approved its mesenchymal stromal cell therapy Ryoncil for steroid-refractory acute graft versus host disease in children 2 months and older, adolescents and teenagers.

Shares of Mesoblast surged 51% in premarket activity Thursday.

The company said Ryoncil is the first FDA-approved treatment for the condition, which often occurs after stem-cell transplants and can cause organ damage.

The approval followed the results of a phase 3 trial in children with the condition which achieved a 70% overall response rate after 28 days of treatment with Ryoncil, the company said.

Ryoncil will be available in the US at transplant centers and hospitals, the company said.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap
Leave a comment