Setback for Boehringer Ingelheim: the company has halted development of its inhaled gene therapy BI 3720931 for cystic fibrosis after a phase 1/2 trial failed to deliver efficacy data supporting further progress. While the safety profile met expectations, the programme has now been shelved.
A late-week surprise from Munich-based Immunic, Inc. (listed on Nasdaq as IMUX): the company has launched a follow-on private placement of up to US$400 million and expects to close the financing later this month. At the same time, the biotech is pressing ahead with its transformation in preparation for the potential commercialisation of its lead asset. Current CEO Daniel Vitt will step back once a successor with proven market-launch expertise has been appointed.
The European Commission has approved Amgen’s Uplizna in generalized myasthenia gravis, moving the big biotech into a market served by argenx, Johnson & Johnson and UCB.
The FDA has approved Novo Nordisk’s blockbuster drug Ozempic (semaglutide) for patients with chronic kidney disease who also have type 2 diabetes.
German AdrenoMed AG has got FDA Fast Track designation for its targeted septic shock medicine enibarcimab that restores endothel integrity.
Roche AG’s US subsidiary Genentech Inc has withdrawn its checkpoint inhibitor atezolizumab from the market after disappointing results in bladder cancer.
Immunic/Nela Dorner
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