SanBio’s lead cell therapy asset has been on a bumpy journey to its global-first approval and while a nod has now come in Japan in a high-need indication, a commercial launch is conditional on additional data to establish product equivalence and manufacturing consistency. 

Technical challenges and lackluster investor sentiment about the near-term commercial potential of cell and gene therapies in neurological disorders may be holding the field back.

Phase II/III studies are underway for Mesoblast’s remestemcel-L and Athersys’ Multistem, followed by a pack of earlier-stage stem cell candidates from Pluristem, Hope Bioscience and Celltex – with an interactive chart of the COVID-19 cell therapy pipeline.

A review of biopharma startup dealmaking and financing activity from January through March 2017, based on data from Strategic Transactions, showed a 19% decline in startup financing compared with the fourth quarter of 2016, but big pharmas provided capital in the form of alliance fees.