ASX Health Stocks: On FDA Monday Mesoblast has lifesaving evidence; Lumos hits a roadblock
Health & Biotech
Health & Biotech
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Mesoblast (ASX:MSB) blasted off as high as 8% this morning after announcing that it has submitted to the US FDA substantial new information in response to the FDA’s Complete Response Letter (CRL) in September of 2020.
The CRL letter refers to the license application for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).
Mesoblast has maintained an active dialog with the FDA since receiving the CRL two years ago, and the company says that today’s submission to the Investigational New Drug (IND) file represents a major milestone in its complete response to the FDA.
The treatment for SR-aGVHD has not improved over the past few decades where survival outcomes remain very low.
The lack of any approved treatments for children under 12 means that there is an urgent need for a therapy that improves the dismal survival outcomes in children.
“The submission summarises controlled data providing further evidence of remestemcel-L’s ability to save lives” said Dr. Silviu Itescu, CEO of Mesoblast.
“Additionally, the improved process controls we have put in place to assure robust and consistent commercial product, together with a potency assay that predicts consistent survival outcomes, makes remestemcel-L a compelling treatment for these children.”
Lumos Diagnostics (ASX:LDX) meanwhile has encountered a major hurdle with the FDA.
The company says that following completion of an appeal requested by Lumos, the FDA has upheld its decision that FebriDx has not demonstrated substantial equivalence to the predicate device identified in its 510(k) application.
Consequently, FebriDx has not been granted clearance for marketing in the US.
The FebriDx test is a rapid, point-of-care (POC) test that uses a fingerstick blood sample to identify patients with a pathogen.
Following this decision, Lumos says it intends to direct its efforts now to commercialising FebriDx in markets where it has been already been granted clearance – such as in the EU, Canada, Saudi Arabia and Singapore.
The company will also now focus on growing its development services and contract manufacturing business.
Lumos could potentially still file a new application to the FDA for FebriDx. However, based on the feedback received from the FDA, this is likely to require further investment and time to generate additional data before a new application could be submitted.
“Clearly this is a disappointing outcome for Lumos as we believe there is a significant need and opportunity for FebriDx in the US,” said Doug Ward, CEO of Lumos.
“However, we are committed to ensuring that investment and expenditure is closely aligned to achieving commercial outcomes for Lumos.
“At this time, this means focusing our efforts on building our services and manufacturing businesses and selling our own POC diagnostic products in markets where they are cleared.”