Navigating the Current State Of FDA: CEO Marcio Souza’s Journey at Praxis Therapeutics

Recorded on 03/03/26

TD Cowen senior biotech analyst Ritu Baral speaks with Praxis CEO Marcio Souza at TD Cowen’s 46th Annual Health Care Conference to discuss FDA functionality following recent leadership changes and destaffing, approaches to working with the agency on complex datasets, and implications for the broader biotech sector. Drawing on Praxis’s extensive regulatory experience, Souza notes that despite chronic FDA understaffing, engagement with the Office of Neuroscience has remained stable and highly productive. He underscores the value of incorporating FDA guidance early in endpoint and trial design in areas such as essential tremor, where regulatory precedent is limited, and emphasizes that frequent, senior-level interaction and a patient-centric framing of complex data can help drive alignment and constructive regulatory dialogue. He adds that investors can gauge the quality of a developer’s relationship with the agency by looking at the recency of FDA communications and the level of senior leadership engagement during recent interactions.

https://go.td.com/PodcastDisclosure

Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.