Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a Pink Sheet analysis of FDA approval decisions since 2021.

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA’s novel agent count fell back to average as agency kept up high rate of complete response letters and refuse to file actions; CBER’s workload shifted to regenerative medicine.

VC funding slowed recently, but public company financings kept up a brisk pace with follow-on public offerings for Allakos and Alpine, private placements for Ventyx and Syros, and Albireo’s royalty deal. In restructuring updates, Biogen raised $592m in a real estate deal and Acerus is assessing options.