Adam Feuerstein

Graig Suvannavejh × Paul Matteis × Brian Skorney × Yaron Werber × Chris Garabedian × Adam Feuerstein

George Tidmarsh’s CBER departure and UniQure’s rejected filing after FDA alignment expose a widening gap between flexible guidance and unpredictable execution.UniQure reported 80% disease slowing at two years and 75% at three years for high dose, while Sarepta’s failed ESSENCE study and December’s Stoke meeting will test evidence standards and early-filing appetite.

Josh Schimmer × Chris Garabedian × Sam Fazeli × Yaron Werber × Adam Feuerstein

Sarepta’s credibility crisis deepened after reporters disclosed a patient death tied to the rAAVrh74 vector, prompting FDA to request halting all Elevidys shipments and a trading halt.Ultragenyx’s CMC-only CRL and GSK’s failed Blenrep ODAC votes signal tighter scrutiny, while large-biopharma M&A and FDA encouragement leave catalysts alongside governance and regulatory risks.

Eric Schmidt × Sam Fazeli × Adam Feuerstein × Peter Kolchinsky

Biotech’s three-week XBI rebound is supported by strong launches, better-than-feared earnings and returning deals, but panelists viewed it as stabilization while FDA disruption, vaccine policy and tariffs continue to discount the sector.BridgeBio’s Attruby highlights commercial execution, while Summit’s ivonescimab—with a 0.77 preliminary overall-survival hazard ratio versus Keytruda—faces pivotal midyear U.S.HARMONi validation; transparency and franchise risks remain visible across the sector.