392: Epstein's pal attempts a biotech comeback, and Prasad exits the FDA
The Readout LoudAI Summary
→ WHAT IT COVERS This episode covers three biotech stories: Vinay Prasad's second departure from the FDA and its impact on rare disease drug approvals, Xenon Pharmaceuticals' phase three seizure trial results, the Novo Nordisk and Hims & Hers compounded GLP-1 settlement, and biotech investor Boris Nikolic's return to venture capital despite deep ties to Jeffrey Epstein. → KEY INSIGHTS - **FDA Leadership Instability:** Vinay Prasad's exit from the FDA's CBER division — his second departure since May — signals a regulatory reset for rare disease drugs. Rare disease biotech stocks rose immediately on the news, reflecting investor belief that CBER will now align with Commissioner Makary's stated goal of accelerating drug approvals rather than increasing trial scrutiny. - **Seizure Drug Breakthrough:** Xenon Pharmaceuticals' azetukalner, a second-generation KV7 potassium channel modulator, reduced focal onset seizure frequency by 53% versus 10% in placebo in a phase three trial. With no currently approved drug using this mechanism, and roughly half of epilepsy patients still experiencing seizures on existing therapies, Xenon plans to file for approval later this year. - **GLP-1 Market Consolidation:** Novo Nordisk settled its patent lawsuit against Hims & Hers, requiring the telehealth company to stop marketing compounded semaglutide and instead offer brand-name Wegovy at direct cash prices. Novo's CEO explicitly stated the goal is increased prescription volume for authentic products, raising questions about telehealth-pharma partnership incentives and patient access to lower-cost alternatives. - **Reputational Risk in VC Due Diligence:** Boris Nikolic raised over $100 million for BioNTell Ventures in 2024–2025 despite public Epstein ties dating to 2019. DOJ files released in January 2026 show Nikolic mentioned over 14,000 times in Epstein documents, with emails showing he sent photos of young women to Epstein for years — information unavailable to investors who committed capital before the release. - **Startup Founder Leverage in Funding Rounds:** When a lead investor introduces a startup to a co-investor, founders may feel unable to reject that capital even when reputational concerns exist. The Curie Bio portfolio company that accepted a Nikolic investment illustrates how funding dependency can override due diligence instincts, underscoring the value of founders understanding their right to decline specific investors. → NOTABLE MOMENT DOJ files revealed Nikolic appears over 14,000 times in Epstein documents — more than any other known associate — and exchanged emails with Epstein spanning 2009 to 2019, including correspondence where photos of young women were sent to Epstein for his selection, far exceeding what even his critics had previously suspected. 💼 SPONSORS [{"name": "Fred Hutch Cancer Center", "url": "https://www.fredhutch.org"}] 🏷️ FDA Regulation, Rare Disease Drugs, GLP-1 Market, Biotech Venture Capital, Jeffrey Epstein