Highlights of recent submissions for approval from the Pink Sheet’s US FDA Performance Tracker

Pink Sheet analysis finds big jump in the share of novel approvals that received PDUFA extensions, largely driven by clinical and safety data submissions.

The US FDA could approve as many new gene therapies in 2023 as it has in the previous five years. Development in the field has rapidly accelerated, but still faces hurdles.

Public Company Edition: Mallinckrodt entered into a restructuring support agreement with most of its debt holders and will de-list. Also, Aprinoia no longer plans to go public in a SPAC merger and Novartis, Agenus and Aravive revealed job cuts.