The US biotech is in the throes of an appeal to the FDA against the rejection of its HIF-PH inhibitor but regulators in the EU have looked more kindly on vadadustat, which will be sold as Vafseo.

Public Company Edition: Mineralys launches the second $100m-plus initial public offering of 2023 and trades higher in its first day. Also, Collegium sells $210m worth of notes, Eliem cuts 55% of its jobs at it shifts to preclinical and Aligos de-prioritizes hepatitis B while reducing its workforce another 10%.

Even before a new law granted FDA authority to require studies be underway before accelerated approval, review divisions have, in some cases, given sponsors years of advance notice on expectations around study timing, according to a Pink Sheet review of NME accelerated approvals.

Pink Sheet infographic breaks down the trends and surprises in 2022 approvals. Cancer therapies and non-malignant hematology exceeded the average use of expedited review programs but were weighted to orphan diseases, while dermatology saw first-in-class approvals for big markets.