Mike Yee

Reshma: the competitor's eGFR stabilization is expected and validates Pove's best-in-class proteinuria and dosing.

Reshma emphasized infections are the key safety metric, not IgG levels themselves. Noted cross-trial IgG comparisons are unreliable due to different measurement frequencies and thresholds.

Reshma deflected direct eGFR comparison, noting FDA doesn't allow sharing eGFR data yet. Emphasized proteinuria as the most proximal marker for long-term outcomes.

Reshma stated ADAs are expected with biologics but neutralizing antibodies impacting efficacy are not a concern based on RUBY-3 data. On AMKD, expects Phase 3 results consistent with Phase 2 since FSGS and AMKD are the same disease with GFR slope as primary endpoint.

Duncan countered deceleration narrative, noting total prescriptions of 25,000 include hospital data not captured in IMS retail data. Last week showed fastest retail growth since launch.

Reshma confirmed VX-993 Phase II results expected H2 2025. 993 is more potent with higher dosing potential, could enable co-formulation with NaV1.7 or potentially improve on JOURNAVX efficacy.

Stuart expressed high confidence in broad coverage citing universal awareness of unmet need and federal/state policy tailwinds supporting non-opioid access.

Singhal answered the comparison head-on, explained why AMETHYST Phase 2 data can be shared early, and set expectations for the EADV 52-week readout.

Priya confirmed study was redesigned after Phase 1b tau reduction gave confidence to reduce power. Primary endpoint CDR sum of boxes with multiple doses and 2 treatment paradigms. Disciplined go/no-go criteria established ahead of readout. Chris noted the bar doesn't have to be statistically significant but must show signs of clinical benefit. No precedent exists for tau-targeting therapy.

Priya confirmed tau PET, fluid biomarkers, and clinical trends will all be evaluated. Study has dedicated tau sub-study. Testing three doses and two dosing regimens in randomized controlled trial. Will triangulate across all data types to assess scientific hypothesis.

Alisha stated myostatin is seen as additive to existing SMA therapies, not a competitive threat to SPINRAZA. Does not view it as a main competitor for current SMA treatment paradigm.

Priya differentiated AHEAD 3-45 as testing full presymptomatic spectrum vs Trailblazer's mixed population (55% presymptomatic, 45% symptomatic). Different endpoints: PACC5 vs CDR. Readout 2028.

Priya explained FDA-approved IVDs are expected in the near-term, with Fujirebio already filed. Acknowledged concordance data and reimbursement still needed but momentum is strong.

Berman noted the Phase 3 requires a minimum 18-month follow-up, capturing the delayed separation seen in Phase 2, which increases confidence.

Hoge confirmed interim threshold not requiring Phase II hazard ratio, something between there and not significant. RCC has registrational potential at lower alpha threshold (0.1). DSMB will advise whether to declare success, continue blinded, or assess futility.

Hoge explained INT Phase 3 uses RFS as primary with interim analysis this year. If insufficient power at interim, proceeds to subsequent analyses. Norovirus is trivalent, seropositive adult population (different from prior failed pediatric studies), case-driven with potential 2026 data.

Hoge set 49.1% VE as lower bound acceptability threshold. Secondary endpoints include virus persistence in blood/urine. On regulatory, noted 3 approvals happened on time and dialogues remain productive.

Majority of participants enrolled in Northern Hemisphere; Southern Hemisphere may not be needed for sufficient case accrual.

Hoge noted 2026 seems possible but wouldn't commit to early vs late timing, citing population differences between Phase II and Phase III.

Bradner detailed OCEAN(a): 7,297 patients, 3-point MACE endpoint, Lp(a) >200 threshold, and said the stroke exclusion does not change the event rate by their modeling.

Jay emphasized Lp(a) is an independent risk factor unaffected by GLP-1s or statins, reinforcing olpasiran's differentiated mechanism and OCEANA-ACE study design with 7,300 patients.

Bradner disclosed AMG 513, an undisclosed-mechanism clinical-stage obesity asset in Phase I, plus preclinical programs spanning incretin and non-incretin pathways including oral and injectable candidates. Emphasized Amgen's long history in obesity since leptin era and stable discovery leadership.

Bradway expressed strong confidence in Phase III design informed by Phase II and Phase I PK learnings. Gordon noted MariTide's monthly dosing makes it less vulnerable to orals than weekly GLP-1s, and Amgen is pursuing its own oral pipeline.

Bradner pushed back on the 'slip-up' framing, emphasizing the pipeline includes integrins, non-integrins, oral and subcutaneous candidates plus external innovation partnerships. Bradway clarified AMG 513 is still expected to advance.

Massacesi explained the dose-response rationale and said the blinded safety event rate has been reassuring, giving two fully powered shots on goal.

Cristian could not disclose baseline characteristics but stated events are accruing as expected and the study remains on track for year-end readout.

Cristian noted enrollment complete at 20,000+ patients, well past the point where oceanic AFib terminated. DSMB continues to endorse progression on both efficacy and safety.

Chris acknowledged metabolics is exciting but said primary BD focus remains on existing TAs where BMY can best add value scientifically and commercially.

Mercier detailed a new Ready to Go support program with SMS reminders, educational resources, and a nurse call center to push persistency above 70%.

Dietmar highlighted two Q6M programs: lenacapavir plus broadly neutralizing antibodies (infusion, earlier) and lenacapavir plus GS-3242 (long-acting INSTI). Emphasized INSTI benefits of tolerability, resistance profile, and forgiveness. Noted competitors need combinations and cannot achieve Q6M on one product alone.

Johanna confirmed access ramp to 75% in 6 months and 90% in 12 months. Early prescriptions will go through medical exceptions as plans come online.

Dan confirmed all lenacapavir PrEP regulatory interactions are on track. Johanna added that breakthrough designation supports the timeline for summer launch.