Cory Kasimov

Berman said RCC immunogenicity data is not available yet, pointing to pancreatic immunogenicity and TMB-independent Phase 2 melanoma results for confidence.

Hoge argued RFS includes survival and tends to correlate with OS. Five-year Phase II update at ASCO will include RFS, DMFS and OS data. Phase III will follow OS but will take time to mature to Phase II-level data.

Hoge noted 2-season design was always a possibility. No change to commercial target product profile; burden of disease well-established globally.

Hoge emphasized adjuvant remains primary bet but manufacturing improvements enable metastatic indication. Over 1,000 patients treated across intismeran studies.

Hoge noted 2-season design was always a possibility. No change to commercial target product profile; burden of disease well-established globally.

CFO clarified no change occurred; confusion was between GAAP costs (including SBC/D&A) and cash costs which remain unchanged.

Yancopoulos directly addressed infection concerns, citing data showing infection risk decreases with longer treatment as bone marrow function improves.

Yancopoulos detailed competitive positioning: most convenient dosing (SC every 3 months), stable deep control throughout dosing period, and potential safety advantage from partial complement inhibition. McCourt confirmed launch readiness and called it a highly differentiated product for a large indication with high unmet need.

Yancopoulos argued Dupixent targets a largely vestigial immune pathway while OX40 and JAK approaches attack fundamental immune mechanisms more broadly, requiring far longer safety track records. Schleifer added that Dupixent's cross-indication reach in patients with comorbidities is a commercial advantage.

Yancopoulos noted few survival events in early-stage population but expressed confidence in the data package. McCourt estimated approximately 10,000 US patients may benefit from adjuvant CSCC.

Reshma: FDA agreement allows an accelerated-approval filing on 1-year GFR at the interim; proteinuria also reviewed.

Reshma set an explicit bar of 20-50% proteinuria improvement on top of standard of care for AMPLIFIED, with results expected in the second half of 2026.

Reshma detailed RUBY-3 80mg IgAN safety data: zero SAEs related to infection at any IgG level, a single patient below 300mg IgG threshold with no serious infection, and average IgG levels within normal range around 700mg.

CCO noted Wainua is slightly more premium than AMVUTTRA and no significant pricing shift anticipated. First-line payer access has improved in 2026 vs 2025.