FDA advisory committee thumbs up on Mesoblast’s Ryoncil

The FDA’s Oncologic Drugs Advisory Committee voted 8-2 backing approval of Mesoblast Limited’s (NASDAQ:MESO) Ryoncil (remestemcel-L) (ex-vivo culture-expanded adult human mesenchymal stromal cells suspension for intravenous infusion) for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients.

The positive vote surprised some observers considering the issues cited in the review team’s briefing document.

Trading, suspended this morning pending the outcome of the meeting, has yet to resume.

https://seekingalpha.com/news/3605318-fda-advisory-committee-thumbs-up-on-mesoblasts-ryoncil