Trial of high-need gene therapy set to restart following the deaths of several participants and the lifting of a clinical hold imposed by the US FDA last year.

The development and commercialization of cell and gene therapies during a pandemic, with regulators and payers demanding more data on effect duration and safety, has resulted in headwinds. Added to manufacturing and clinical trial recruitment issues, investors’ patience has been strained.

Japanese firm sees broad promise in already affiliated US bioventure’s platform tech that will help it become a more global player in genetic medicine.

Astellas subsidiary says it “remains committed” to on-hold program in high-need disease despite fatal events.