Feb. 2 Quick Takes: Pharming plans global submissions for leniolisib

Pharming Group N.V. (Euronext:PHARM) is planning global regulatory submissions starting next quarter for PI3Kδ inhibitor leniolisib following a pivotal Phase II/III readout to treat activated PI3Kδ syndrome (APDS), an ultra-rare primary immunodeficiency. Pharming said Wednesday that the therapy met the study’s co-primary endpoints of reduction in lymph node size (p=0.0012) and correction of immunodeficiency (p<0.0001) versus placebo. The company licensed leniolisib from Novartis AG (SIX:NOVN; NYSE:NVS) in 2019 for $20 million up front plus undisclosed milestones and tiered double-digit royalties.

Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO) disclosed in its 4Q21 earnings that it had declined to exercise its option to acquire Staten Biotechnology B.V. this month. Novo acquired the option under a 2018 deal to develop APOCIII inhibitor STT-5058; the option had a €100 million ($111.7 million) exercise fee. Separately, Novo reported that 2021 revenues for diabetes drug Ozempic semaglutide rose 59% to DKK33.7 billion ($5.1 billion), making the once-weekly GLP-1 agonist the Danish pharma’s top-selling drug. ...