Six new breakthrough therapy designations have been announced, all for novel agents, but approvals were fewer and limited to new indications and formulations.

Incyte’s Jakafi-dominated portfolio gained Opzelura as a second source of significant revenue in 2021. While further diversification has been limited, new and existing R&D assets may deliver upside in 2024.

Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.

Public Company Edition: Syndax grossed $230m in a follow-on public offering based on positive results for its menin inhibitor in leukemia, but the FOPO was an outlier relative to other companies, which relied on private placements, debt and other options to raise cash in a tough market.