Nina Kjellson

Chris Garabedian × Josh Schimmer × Nina Kjellson × Mike Yee × Tim Opler

Summit’s PD-1×VEGF bispecific missed overall survival at p=0.0575, sending shares down 25% despite a PFS hit and 20% lower mortality risk in Western patients.Tim Opler sees VEGF×PD-1 becoming oncology’s backbone, while Pfizer’s 3SBio license and Seagen acquisition give it control for ADC combinations.Macro uncertainty favors discounted commercial-stage M&A, and Gilead’s June 19 lenacapavir PDUFA will test FDA functionality.

Sam Fazeli × John Maraganore × Nina Kjellson × Matt Gline

Monday's MFN order creates a 30-day voluntary period and 180 days of negotiations, with no government-scale implementation or US price pressure expected by end-2025.Because US pricing controllers generally prefer higher prices, MFN could raise ex-US prices and leave biotech underrepresented, while conditional $234B pledges, CMS's 2028 subQ test, and CytomX's $100M financing provide catalysts.

Eric Schmidt × Brad Loncar × Yaron Werber × Paul Matteis × Nina Kjellson

FDA instability now outweighs tariffs as biotech’s central risk, with Peter Marks’s resignation and layoffs leaving its direction unclear.Ultragenyx, REGENXBIO and Denali will test whether prior FDA agreements and CSF heparan sulfate-based accelerated-approval pathways hold, while Lilly’s lepodisiran cut Lp(a) 93.5% at six months.Pelacarsen’s outcomes readout moves to the first half of next year.