Mesoblast faces FDA pushback
The FDA will meet with Mesoblast to determine their ability to produce their treatment (Ryoncil) remestemcel-L. While the Phase III trial of this treatment showed positive results, it is not clear if the patient outcomes were directly connected to this treatment. Mesoblast produces (Ryoncil) from mesenchymal stromal cells.
“While (Ryoncil) and other MSC-based investigational products have demonstrated apparent immunomodulatory effects in in vitro experiments, the ability of (Ryoncil) to reduce inflammation as measured by inflammatory biomarkers in humans receiving the product has not been demonstrated,” the FDA said.
Besides, the FDA considers the manufacturing process as a potential obstacle. In fact, they believe that production might be diluted because Mesoblast relies on donor banks. Thus, the FDA will complete a full review on September 30.
In February 2018, Mesoblast showed important data from a Phase 3 trial in pediatric GVHD. 69% of patients in this study benefited from a response to the treatment after 28 days. Moreover, Japan approved this therapy under the name Temcell, there it is licensed to JCR Pharma.
Mesoblast is conducting studies for Ryoncil in adult and chronic GVHD as well as to acute respiratory distress syndrome in COVID-19 patients.
The stock price of Mesoblast fell from $17.42 at Monday’s close to a low of $10.93 after this review from the FDA.