So Far, Still So Good For Seattle Genetics/Astellas’ Bladder Cancer ADC
Updated data from the Phase II EV-201 study of Seattle Genetics/Astellas Pharma’s novel ADC are strong enough to warrant accelerated approval, its investigators claim. An accelerated submission to the US FDA is due later this year.
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Public Company Edition: Two months before the deadline for the company's sNDA, the US FDA has not indicated it will hold an advisory committee meeting for the triglyceride-lowering drug. Also, Seattle Genetics raises $575m, Atara and Ra bring in $150m each and Cara completes $145.5m offering.
The latest drug development news and highlights for our US FDA Performance Tracker.
The company extended its series E financing to $276m to keep its two lead ADC candidates moving toward pivotal data and BLA filings, including a planned filing for ADCT-402 late next year. The funding news comes as the ADC field moves into the spotlight.