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- Mesoblast (MSB) is preparing for two major milestones for its allogeneic cell therapy remestemcel-L treatment
- Mesoblast is trialling its remestemcel-L treatment to see if it improves the survival rate of COVID-19 patients with acute respiratory distress syndrome
- The independent Data Safety Monitoring Board is expecting the first interim analysis of the phase three trial will be completed by early Septemeber
- In May, the food and drug administration (FDA) accepted priority review of the company’s biologics licence application (BLA) to gain approval for remestemcel-L
- The Oncologic Drugs Advisory Committee from the FDA will have a meeting with the company in August to review its data from the BLA
- Mesoblast said it will take notes from the panel but the final decision regarding the approval of the product will be made by the FDA alone
- Company shares are up 4.66 per cent on the market this afternoon and are trading for $3.82 per share
Mesoblast (MSB) is preparing for two major milestones for its allogeneic cell therapy remestemcel-L treatment.
The two milestones are the ongoing phase three trial of remestemcel-L in COVID-19 patients and the potential FDA (food and drug administration) approval.
COVID-19 patients
In April, the company began enrolment for a phase two and three randomised, placebo-controlled trial for remestemcel-L.
Mesoblast is trailing the product to see if it improves the survival rate in COVID-19 patients with acute respiratory distress syndrome (ARDS). Up to 30 medical centres across the United States are expected to participate in the trial.
Now, the independent Data Safety Monitoring Board (DSMB) is expecting the first interim analysis of the phase three trial will be completed by early Septemeber.
The trial’s first 90 patients will complete the 30 days of follow up next month, after which the DMSB will analyse the review and tell Mesoblast to continue with the trial or stop it early.
There are currently no approved treatments for COVID-19 ARDS, which is the main cause of death with the virus.
FDA approval
In May, The United States FDA accepted priority review of the company’s biologics licence application (BLA) to gain approval for remestemcel-L, which is branded under the name Ryoncil.
The Oncologic Drugs Advisory Committee from the FDA will have a meeting with the company in August to review its data from the BLA. Mesoblast said it will take notes from the panel, but the final decision regarding the approval of the product will be made by the FDA alone.
Fourth-quarter financials
Mesoblast had US$129.3 million (approximately A$188.4 million) cash on hand at the end of the fourth quarter. It also completed a US$90 million (around A$138 million) capital raise to global investors.
Over the next 12 months, the company could have access to an additional US$67.5 million (around A$94 million) through existing financing facilities and strategic partnerships.
Mesoblast burnt US$19.6 million (roughly A$27.32 million) during the quarter as the company prepares for the potential approval and commercial launch of remestemcel-L. The company spent the money on research and development, manufacturing, royalty receipts and payments to related parties.
Company shares are up 4.66 per cent on the market this afternoon and is trading for $3.82 per share at 1:51 pm AEST.
