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Nayan Patel: Appreciate your time today

& Balda, B

Officially, the FDA cites: Insufficient large-scale clinical trials Concerns about consistency, sourcing, and manufacturing standards The need to meet formal drug approval requirements Critics argue (fairly) that this system: Favors large pharmaceutical companies Makes it hard to approve naturally occurring peptides Leaves promising, low-risk compounds in regulatory limbo The short version: This FDA restrictive regulatory change of mind wasnt driven by a sudden safety scare, it was driven by regulatory process and economics

Compounded semaglutide, for one, isnt user-intuitive, requiring patients to draw up doses in vials rather than use pre-filled pens

Clinical trial data showed that serious adverse events, including pancreatitis, were rare and not dose-dependent with cagrilintide

Amgen, Viking Therapeutics, Boehringer Ingelheim, Zealand Pharma, and Pfizer are also important watchlist companies