Only two breakthrough-designated novel agents remain on the US FDA drugs center’s 2023 user fee calendar, while CBER stacks up on vaccines and gene therapies under both BTD and RMAT programs.

The German biotech presented updated data at ESMO showing strong efficacy in ovarian cancer and other solid tumors, albeit with a higher degree of adverse events, particularly cytokine release syndrome.

Plus deals involving SK Biopharmaceuticals, Hikma and Proteovant, Day One/Sprint, Eyenovia/Formosa, Clinigen/CNX, Ikena/Pionyr and more.

Public Company Edition: Apogee grossed $300m and Sagimet raised $85m in the biggest initial public offerings in the US since Acelyrin’s $540m IPO in May. Also, Bausch entered into a $600m funding facility with KKR, Bicycle raised $200m in a FOPO and Caribou garnered $150m from an offering and Pfizer.