Ami Fadia

John Maraganore × Yaron Werber × Ami Fadia × Allison DeAngelis × Drew Armstrong

Rick Pazdur’s CDER appointment may steady FDA leadership, but the vague “plausible mechanism pathway” and its apparent conflict with uniQure keep regulatory execution a key risk.Competitive M&A—Lundbeck’s $2.6B Avadel bid versus Alkermes’ $2.1B offer—and Cogent’s PEAK, with 16.5-month mPFS in second-line GIST, create catalysts, while Intellia’s clinical hold keeps gene-editing safety unresolved.