FDA critics barely lay a glove on Geron
Imetelstat appears headed for approval after its US adcom turns into a damp squib.
Boundless and others head for phase 1
First-in-human study initiations include Boundless Bio’s second asset, and an ADC from Tubulis.
Merck matches Kelun’s saci-tirumo efforts
Three recently added trials take Merck & Co’s tally of phase 3 sacituzumab tirumotecan studies to six.
Multiple myeloma Car-Ts face a US grilling
The FDA highlights high death rates and questions overall survival for Carvykti and Abecma.
Seven problems for Geron
Brutal FDA briefing documents raise questions about the approvability of imetelstat for myelodysplastic syndromes.
Deals mask CytomX’s fundamental problem
Another disappointment raises fresh doubts about CytomX’s extensively partnered masked therapeutics.
Adcetris gives Pfizer its first post-Seagen surprise
The Echelon-3 study seemed doomed, but it just read out positively for overall survival.
