2026 Regulatory Readiness Playbook for Life Sciences

Genentech is paying Earendil Labs $55 million upfront in a deal worth over $1.5 billion to develop bispecific antibodies for hard-to-treat cancers.

Acuitas CEO Dr Thomas Madden and NanoVation co-founder and president Dr Dominik Witzigmann discuss how LNP engineering is expanding genetic medicine applications to traditionally undruggable targets.

Guselkumab eased spinal pain, stiffness, and MRI-confirmed spinal inflammation in a 411-patient trial of psoriatic arthritis with axial involvement.

AstraZeneca's sBLA for durvalumab combined with neoadjuvant enfortumab vedotin in muscle-invasive bladder cancer, based on the Phase 3 VOLGA trial, has a PDUFA date expected in the fourth quarter of 2026.

IMVT-1402 (imeroprubart) failed to reach statistical significance on CLASI-A at Week 12 in a 57-patient proof-of-concept study, and Immunovant will stop development in cutaneous lupus erythematosus. The anti-FcRn antibody continues in five other autoimmune indications.

SOTIO Biotech's LRRC15-targeted antibody-drug conjugate SOT106 now holds both Orphan Drug and Fast Track Designations in soft tissue sarcoma and osteosarcoma. The company expects to start first-in-human testing later in 2026.

Dr Stephen Wilson, CEO of the Botnar Institute of Immune Engineering, describes Basel's collaborative ecosystem and a 3-year roadmap linking research to global clinical partners.

Johnson & Johnson's modeling projects 18.5-year life expectancy with Tecvayli-Darzalex versus 4.9 years for standard care.