The rare disease firm hopes continued growth of key products Myalept and Mycapssa will bolster 2022 revenues as it contends with a US regulatory delay for Filsuvez.

Public Company Edition: As their stock prices plummet, Adagio reshuffles its research plan and names a new CEO, while Yumanity restructures and seeks strategic alternatives. Also, Bristol sells $6bn worth of notes, Amgen issues $750m green bond, and Inhibrx and Amryt amend and refinance debt.

A regulatory filing for Vyjuvek in the US is targeted for the first half of 2022 following the positive results of a Phase III trial, positioning Krystal for its first commercial launch.

Brazil has established an accelerated pathway for approval of drugs for ultra-rare diseases, encouraging development activity – but the definition of qualifying drugs is narrow. Expansion to include more treatments could boost clinical trials activity and companies’ overall development presence.