If finally fully approved in its first indication, the HGF gene therapy could become a first-in-class therapy for PAD - but only after years of challenges in clinical trials.

Plus transactions involving Sanofi/Fulcrum, Reneo/OnKure, Lilly/Mitsubishi Tanabe, Lantern/Oregon, Zydus/Eiger and more.

The company had pivoted towards a drug with the opposite mechanism to Novo Nordisk’s Wegovy, but ran out of time and money.

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.