ARK Weekly Roundup: Prasad FDA Departure, Tesla-xAI Digital Optimus, Air Taxi Pilots

[!warning] Conflict of Interest ARK Invest is an active fund manager promoting its own positions. ARK holds Tesla and biotech names discussed. Read with appropriate skepticism.

Key Themes

• Prasad departs FDA again: CBER Director Vinay Prasad leaving end of April after controversial tenure. Multiple rare disease therapy rejections (UniQure Huntington’s, REGENXBIO Hunter syndrome). FDA reform trajectory expected to continue despite departure: plausible mechanism pathway, one-pivotal-trial default, national priority review.
• Tesla-xAI “Digital Optimus”: xAI partnering with Tesla to build Macrohard/Digital Optimus — smaller AI models running on Tesla’s AI4 chip ($650, ~10x cheaper than Nvidia B200). Hybrid edge-to-cloud architecture using millions of AI4 chips in Tesla vehicles. Could deploy at supercharger locations for additional 7GW of compute. SpaceX space-based compute another scaling path.
• eVTOL pilot program: FAA selected 8 projects across 26 states for eIPP. Operations launching as early as summer 2026. Joby completed 20+ test flights in Dubai. ARK claims eVTOL at scale could be priced comparably to ride-hail.

RDCO Relevance

FDA reform trajectory analysis useful for biotech investment thesis. Tesla/xAI edge computing model is a novel distributed compute architecture worth monitoring. eVTOL timelines worth tracking against urban mobility projections.