FDA review of the company's BLA for a hemophilia gene therapy could be delayed by three months to allow the agency to review a three-year data analysis from an ongoing trial.

During Q3, biopharmas brought in an aggregate $18.1bn in financing and device company fundraising totaled $5.1bn; while in vitro diagnostic firms and research tools players raised $771m.

Bryan, who oversees reviews of gene and cell therapies in US FDA’s biologics center, cautioned against falling in love with a biomarker when it is showing no ‘clinical effect.’

Mereo will reduce its headcount by 40% to focus on its lead programs while NeuBase revealed a 60% workforce reduction to extend its cash runway. Also, Invivyd (formerly Adagio), Greenlight and BioMarin announced job cuts, while Otonomy and others planned strategic shifts.