Mesoblast (ASX:MSB) shares fell -4.45% in the first hour of trades on Tuesday as the company announced it has to resubmit an application to the FDA.
Shares were trading at $1.07ea per Cboe live pricing at 10.35am Sydney time as traders punish – or sell out of – the company for the backward step. The FDA is notorious for placing onerous administrative burden on companies through its various approvals pathways.
The company was told by the US regulator in March that the Phase 3 trial data for Ryoncil – remestemcel-L – was insufficient on which to grant an approval.
Ryoncil is ultimately a stem cell-based medical product designed for IV injection.
Mesoblast has now re-sent off a biologic licence application (BLA) for the approval of Ryoncil in children with steroid-refractory acute graft-versus-host disease (GVHD.) The condition is well known for its ability to lead to complications in skin transplants and hair transplants.
“We have worked closely with the agency and thank them for their ongoing guidance, facilitating the potential approval of RYONCIL and addressing the urgent need for a therapy that improves the dismal survival outcome in children with SR-aGVHD,” Mesoblast CEO Dr. Silviu Itescu said.
News isn’t all bad. The FDA has previously awarded Ryoncil fast-track designation, meaning that regulators are closely interested in the prospective benefits of the drug.
For such fast tracking to be granted, the FDA must be satisfied there’s at least a chance any drug being proposed could be superior to existing marketed products.
Mesoblast anticipate the fresh BLA application to have a review period of anywhere from two to six months – once it’s accepted.
MSB last traded at $1.07/sh.