Response rates in a key group shrink from 62% to 39% as the company blames a “clerical error”.
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What similarly acting projects are still unpartnered?
Carvykti sailed through Friday’s adcom, but Abecma got a much rougher ride.
First-in-human study initiations include Boundless Bio’s second asset, and an ADC from Tubulis.
Imetelstat appears headed for approval after its US adcom turns into a damp squib.
The company reckons its tech could solve problems with current ADCs, but the market isn’t giving it much credit yet.
Brutal FDA briefing documents raise questions about the approvability of imetelstat for myelodysplastic syndromes.
The FDA highlights high death rates and questions overall survival for Carvykti and Abecma.
