Regulatory friction and financing maneuvers converged for Denali Therapeutics this week. The FDA placed a hold on Denali’s planned Phase 1 study for a Pompe-disease candidate, requesting protocol updates after preclinical immune-reaction signals. Separately, while awaiting an April decision on its Hunter syndrome drug, Denali struck a royalty financing deal with Royalty Pharma that can provide up to $275 million tied to approvals and regional milestones. Royalty Pharma agreed to upfront funding contingent on U.S. and EU approvals in return for a percentage royalty on sales, structuring payments to support Denali’s near-term cash needs. Denali said the funds will underpin continued development and potential launch preparations if regulators greenlight tividenofusp alfa. Investors and partner companies should note the juxtaposition: regulatory holds can pause clinical momentum, but outcome-linked financing can shore up runway and commercial readiness. The Denali deal underscores how biotechs are increasingly layering contingent capital solutions while navigating uncertain regulatory timelines.