Episode 141 - May 9, 2025

On this week’s episode, Grace Colón, Josh Schimmer, Sam Fazeli, Tess Cameron, Eric Schmidt, and Yaron Werber kick off with a discussion on recent policy moves including the appointment of Vinay Prasad as the director of the FDA’s CBER division and nomination of Casey Means for U.S. Surgeon General, noting the impact on the XBI and uncertainty around vaccine gene therapy approvals. The group pondered what kind of regulator Prasad may be, predicting a stricter approach than his predecessor, Peter Marks. The conversation covered the shifting dynamics in vaccine approvals under the new FDA leadership, highlighting that delays like Novavax’s flu combo signal heightened scrutiny, with mRNA follow-ons likely to pass under stricter labels, while new vaccines face raised efficacy bars. On the policy front, Trump’s proposed “Most Favored Nation” drug pricing strategy raises alarms over a potential trillion-dollar hit to innovation and unintended consequences for U.S. drug prices. The conversation shifts to early data on Genocury’s in vivo CAR-T, PTC’s mixed Huntington’s disease results, and Krystal’s gene therapy for neuropathic keratitis. The episode concludes with a roundup of Q1 earnings results. *This episode aired on May 9, 2025.