The major’s antiviral has hit the mark in a late-stage study of CMV disease prevention in the post kidney transplant setting, triggering plans for a US filing to expand its indication from stem cell transplant patients.

Public Company Edition: MAIA launches a $10m initial public offering, the first in the US since May, but NewAmsterdam opts for the SPAC route to the stock market. Also, Legend raises $350m in a follow-on offering, Iveric obtains access to $250m in debt and Otonomy cuts costs after a Phase II failure.

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.