Crowded calendar could bring to an end the slow start for novel approvals in 2024, as decisions come due for Lilly’s donanemab, Merck’s sotatercept, Regeneron’s odronextamab and more.

Public Company Edition: Denali, Crinetics and Ocular Therapeutix grossed $500m, $350m and $325m, respectively, in private placements ahead of data readouts. Also, Viking raised $550m after its positive Phase II obesity data and Abingworth invested $210m in Gilead’s Trodelvy NSCLC trials.

Iovance Biotherapeutics' Amtagvi (lifileucel) received approval from the US FDA in February, marking a truly pivotal milestone in the field of solid tumor therapy for certain adult patients with unresectable or metastatic melanoma. As the first approved tumor infiltrating lymphocyte (TIL) therapy, it is set to expedite the regulatory pathway for next-generation products.

Melanoma treatment Amtagvi is US FDA’s biologics center’s first novel approval of 2024.