- Mesoblast (MSB) shares have lost more than a third of their value after the U.S. Food and Drug Administration recommended the company’s Remestemcel-L treatment should undergo another trial
- Remestemcel-L aims to treat pediatric steroid-refractory acute graft versus host disease (SR-aGVHD)
- As there is no known cure for this life-threatening illness in kids, Mesoblast will request a meeting with the FDA to discuss a potential accelerated approval
- The company expects the meeting to be held within the next month and said any approval depended on a post-approval study
- Today’s pre-market-open announcement comes after the company entered a trading halt ahead of the news yesterday
- Now that shares have resumed trading, MSB shares have dropped a staggering 38.4 per cent to trade for $3.13 each
Mesoblast (MSB) shares have lost more than a third of their value after the U.S. Food and Drug Administration recommended the company’s Remestemcel-L treatment should undergo another trial.
Remestemcel-L aims to treat pediatric steroid-refractory acute graft versus host disease (SR-aGVHD), a life-threatening illness in children under 12. The company is also testing the treatment on severe acute respiratory distress syndrome (ARDS), brought on by COVID-19.
However, while the Oncologic Drugs Advisory Committee (ODAC)1 of the FDA voted nine-to-one that Remestemcel-L was effective in treating SR-aGVHD, the drug administrator still recommended Mesoblast conduct at least one additional randomized, controlled study in patients to provide further evidence of its effectiveness.
In response to the FDA’s request for additional testing to be carried out, Mesoblast has announced it will seek an urgent meeting with the agency to request a potential accelerated approval, with any approval dependent on a post-approval study being conducted.
The ASX-200 listed company advised shareholders it expects this next meeting with the FDA to happen within 30 days of the request being sent. It also expects an update on its phase-three trial of Remestemcel-L on the COVID-19 related ARDS in November this year.
“We are working tirelessly to bring remestemcel-L to patients with life threatening inflammatory conditions, including SR-aGVHD and COVID-19 ARDS,”Mesoblast Chief Executive Dr Silviu Itescu stated.
Today’s announcement comes after the company entered a trading halt yesterday as it geared up to release the important update to the market.
Now that shares have resumed trading, MSB shares have dropped a staggering 38.4 per cent to trade for $3.13 each at 10:40 am AEST.