Latest regenerative medicine advanced therapy awards from US FDA address B-cell acute lymphocytic leukemia, acute respiratory distress syndrome associated with COVID-19, infection risk in stem cell transplant patients, and an ultra-rare form of severe combined immunodeficiency.

Gaining the special regulatory status in a prophylactic setting for posoleucel is the most significant yet for the T cell therapy developer.

With $845m raised to date, ElevateBio will keep building its cell and gene therapy manufacturing capabilities and continue creating new companies and partnerships, but with a global focus.

Regulatory review resource-intensive cell and gene therapy licensing applications are rolling toward US FDA along expedited pathways, while complete response letters and missed goal dates start to stack up under pandemic inspection constraints.