Royalty Pharma agreed to provide up to $275 million to Denali tied to potential approval of tividenofusp alfa, giving Denali contingent capital while the FDA delays a regulatory decision. The financing gives Denali near‑term liquidity backed by future sales if the drug secures approval in the U.S. and Europe. At the same time, the FDA placed a clinical hold on a Denali Phase 1 rare‑disease study, citing immune‑reaction concerns in preclinical models. The juxtaposition—new contingent financing alongside regulatory setbacks—illustrates how biotechs are hedging commercial plans while responding to agency safety questions and shifted review timelines.