Episode 165 - December 5, 2025

On this week’s episode, Josh Schimmer, Brian Skorney, Paul Matteis, and Graig Suvannavejh share their outlook for the biotech industry in 2026, including a lively discussion on IPO market and predictions for what to expect next year. The discussion then shifts to Washington, where Tracy Beth Høeg has been appointed acting CDER director -- the fifth person to lead CDER this year -- following Richard Pazdur’s sudden retirement and ongoing staffing volatility at the agency. Next the co-hosts mention the FDA’s moves to speed up drug approvals, the plausible mechanism pathway, and latest with vaccine policies. The FDA’s final minutes from a pre-BLA meeting with UniQure and the implications for the broader gene therapy landscape are also discussed. Capricor’s positive DMD cell therapy results are also highlighted, reviving hopes for FDA approval. The conversation shifts to data news, including BMS’ update on the ADEPT-2 study readout for Cobenfy in Alzheimer’s disease psychosis, which the co-hosts read as a net positive. Praxis Medicine’s positive Phase 2 results for its seizure drug and ongoing FDA discussions, and Janux Therapeutics in prostate cancer. Otsuka pricing Voyxact at $390K a year is briefly mentioned. The episode concludes with excitement for upcoming conferences including ASH and JPM. *This episode aired on December 5, 2025.