Akebia Could Face Long, Costly Effort To Overcome Vadadustat CRL
Company Pins Hopes On Partner Otsuka’s EMA Application
The US FDA turned down approval for vadadustat in chronic kidney disease anemia, in a complete response letter that unexpectedly included the dialysis-dependent indication.
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GSK could have the US market to itself if it can convince the expert panel of daprodustat’s safety, as rivals have fallen by the wayside.
Public Company Edition: Only nine drug developers went public in the US, raising $807m in the first quarter, versus 32 IPOs raising $5.2bn in Q1 of last year. Also, MoonLake closed its SPAC merger, Sanofi priced €650m in sustainability-linked bonds in €1.5bn note sale, and Kaleido will cease operations.