Shares in Mesoblast (ASX: MSB) were down 40 per cent this morning after the company was ordered to conduct additional tests on its graft versus host disease (GvHD) treatment remestemcel-L.
After receiving the backing of the Oncologic Drugs Advisory Committee in August, the company today told shareholders the US Food and Drugs Administration (FDA) recommended at least one additional study be completed.
The FDA is looking for more evidence that remestemcel-L, marketed as "Ryoncil", is effective at treating GvHD before it approves the drug.
Mesoblast says it will urgently request a meeting with the FDA within the next 30 days to discuss a potential accelerated approval with a post-approval condition for an additional study.
MSB managing director Joanne Kurtzberg says the request was made as there are currently no approved treatments for GvHD, a life-threatening disease for children under 12.
"The Phase 4 trial results showed that remestemcel-L provides a meaningful treatment for children with SR-aGVHD who have a very dismal prognosis," says Kurtzberg.
"I look forward to having this much-needed therapy available to our patients."
The FDA also identified a need for further scientific rationale to demonstrate the relationship of potency measurements to the product's biologic activity.
Shares in Mesoblast are down 35.43 per cent at 11.53am AEST.
Business News Australia