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.

Already planning to position infigratinib as a safer, more convenient oral therapy for dwarfism compared with the BioMarin injectable, BridgeBio now has Phase II efficacy data showing a higher growth rate.

The new data bolster the company’s hypothesis that more specific targeting of FGFR2 can overcome the toxicity limitations of other FGFR inhibitors.

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