Update on Scheduled FDA Advisory Committee Meeting

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Go back to Update on Scheduled FDA Advisory Committee Meeting

Mesoblast (MESO) Receives Backing from FDA Panel for Remestemcel-L

August 13, 2020 5:05 PM EDT

Mesoblast (NASDAQ: MESO) Receives Backing from FDA Panel for Remestemcel-L

FDA ADCOMM VOTE: Do the available data support the efficacy of remestemcel-L in pediatric patients with steroid-refractory aGVHD?
8-Yes
2-No
0-Abstain
aGVHD = acute graft-versus-host disease$MESO #Ryoncil #MesenchymalStromalCells #StemCellTherapy

SAC Tracker (@FDAadcomm) August 13, 2020

... More

Despite Concerns, Cantor Fitzgerald Thinks Mesoblast's (MESO) Ryoncil Could Be Approved

August 11, 2020 8:19 AM EDT

Cantor Fitzgerald analyst Louis Chen weighed in on Mesoblast Limited (NASDAQ: MESO) after shares were slammed 25%+ following FDA briefing documents that raised the "Fear Factor" about Ryoncil, in the treatment of steroid-refractory acute graft versus host disease (SR-aGVHD) in children. Chen thinks Ryoncil could be approved despite the fears.

The FDA AdCom for MESO's Ryoncil is on 8/13 from 8am to 5pm ET. The FDA's Oncologic Drugs... More