Next-generation T-cell engager (TCE) specialist Cytospire Therapeutics Ltd. has raised £61 million (US$82.7 million) in a series A round, equipping it to advance the lead program CYT-X300 to the clinic in the treatment of EGFR-positive solid tumors. The company’s pan gamma delta (γδ) TCEs are designed to overcome problems with cytokine release syndrome, on-target effects on healthy cells, and the excessive activation of CD3 that have occurred with earlier bispecific antibodies that bind to the CD3 receptor on T cells.

UCB SA agreed to pay $2 billion up front to acquire bispecific T-cell engager (TCE)-maker Candid Therapeutics Inc. and lead BCMA/CD3 TCE asset cizutamig (CND-106), continuing big pharma’s spree for China-made autoimmune assets in 2026.

Regulatory uncertainty that dominated the life science sector in 2025 is transitioning into an execution framework for biotechnology companies, provided companies can tailor regulatory strategies early, and across the entire development cycle.

As Celcuity Inc. awaits a U.S. FDA approval decision for gedatolisib in HER-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, the company already is setting its sights on a supplemental NDA filing, based on a top-line readout of the multi-target PAM inhibitor in a PIK3CA-mutant breast cancer cohort.

For the first time in 13 years, the U.S. Trade Representative (USTR) singled out one of the U.S. trading partners as the worst of the worst when it named Vietnam as a Priority Foreign Country (PFC) in its newly released Special 301 Report.