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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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.
Keeping Track: Novel Oncologics Submitted By Taiho, ImmunoGen, Y-mAbs; US FDA Declines Akebia’s Vadadustat
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
The EU approval is good news for FibroGen and marketing partner Astellas, but was expected, and still leaves it pondering its future after FDA knock-back.