- Medical research company Mesoblast (MSB) has taken a dive today despite announcing what appears outwardly as good news
- The company’s novel remestemcel-L treatment, or RYONCIL, is due to be assessed by the U.S. Oncologic Drugs Advisory Committee (ODAC) this week
- The meeting between Mesoblast and ODAC will discuss the attributes and efficacy of RYONCIL as a treatment for complications from stem cell transplants in children
- The ODAC will then vote on whether or not to recommend the treatment for FDA approval
- Still, today’s late-market announcement did little to budge the company’s slumping shares
- Mesoblast closed Tuesday’s session 31 per cent lower at $3.36
Medical research company Mesoblast (MSB) has taken a dive today despite announcing what appears outwardly as good news.
FDA meeting
The company’s novel remestemcel-L treatment, or RYONCIL, is due to be assessed by the Oncologic Drugs Advisory Committee (ODAC) of the United States Food and Drug Administration (FDA) in a meeting with Mesoblast’s team.
The ODAC will review data supporting the company’s Biologics License Application (BLA) for approval of RYONCIL in the treatment of steroid-refractory acute graft versus host disease (SR-aGVHD) in children.
The meeting will be held on Thursday, August 13.
Two sessions will be held to discuss the attributes of RYONCIL and whether the available data supports the efficacy of remestemcel-L in pediatric patients with SR-aGVHD.
The ODAC will then vote on whether or not to recommend the treatment for FDA approval.
The recommendation is not binding and final approval rests solely with the FDA.
Next steps
Mesoblast says it has prepared extensively for the meeting and a briefing book is publicly available.
Of course, today’s news was only released to shareholders with just over an hour of trade to go; Mesoblast shares were already tanking before the announcement was made.
Despite the generally positive news that the RYONCIL treatment is moving toward the approval stage, the sell-off continued. Mesoblast has shed over 30 per cent of its share value in a day, wiping out three weeks’ worth of gains.
Perhaps today’s action is a readjustment after a month of positive newsflow inflated MSB’s price.
Mesoblast closed Tuesday’s session 31 per cent lower at $3.36.