The month ahead: September’s upcoming events
It’s a new term for biotech and its investors.
FDA doubles down on overall survival
New draft guidance could see the agency getting ever stricter.
Gilead gets into in vivo Car-T
Interius, one of the most advanced players, will cost $350m.
Astellas and Amgen join the pan-KRAS push
Astellas’s pan-KRAS degrader joins the company’s two clinical-stage G12D degraders.
Astra’s Neogene investment nosedives
NT-125 is discontinued, while two key Datroway readouts are delayed.
Bristol pulls ahead of Amgen
The company will start a phase 2/3 trial of its Mirati-originated PRMT5 inhibitor in autumn.
Sino takes out the rest of Merck’s partner
LaNova, which licensed a PD-1 x VEGF to Merck, is acquired by another Chinese player.
FDA red and green lights: June 2025
Controversial nods came for Urogen’s Zusduri and Astra/Daiichi’s Datroway.
BeOne also needs B7-H4 biomarkers
The company’s BG-C9074 looks competitive, but there are questions about cutoffs and confirmed responses.
