User fee goal dates in April include four novel agents with breakthrough therapy designations, including Pfizer’s hemophilia B gene therapy and Immunity Bio’s IL-15 superagonist complex for bladder cancer.

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.

Johnson & Johnson’s historical strength in immunology will form the foundation of a renewed push in the field, with novel candidates for indications such as psoriasis, arthritis and inflammatory bowel disease.

Listed Korean bioventures are increasingly opting for rights offerings in a high interest rate environment, while unlisted firms are turning more to smaller-scale VC financings.