Matt Phipps

Jay acknowledged inflammatory reactions caused the pause but was limited on specifics, saying they are collecting patient data and expect to reopen enrollment shortly.

Gordon said Amgen's technical capabilities position it to compete regardless of regulatory requirements. Bradway defended the current biosimilar market as working well and cautioned against policies that could push it toward generic drug industry dynamics.

Bradner described AMG 732 as a next-gen subcutaneous IGF-1R antibody now in Phase II for moderate-to-severe active TED. Bradway framed it as validating the innovation thesis behind the Horizon acquisition.

Gordon described 1-2 million U.S. CRSwNP patients with ~40% asthma overlap. Clinical trials showed near-complete elimination of need for surgery. PDUFA date October 19, 2025.

Adam noted 80% community setting use across multiple tumor types, tracking expectations. Permanent J code July 1 will accelerate H2 subcu conversion.

Adam characterized MF opportunity as modest. Focus remains on first-line RF-negative MDS. Non-transfusion dependent readout next important catalyst.

Samit noted novelty of MRD as regulatory endpoint means durability requirements remain under discussion. Evaluating MRD across other myeloma assets.

Adam acknowledged competitive pressures but confirmed commitment. Highlighted GPRC5D (Arlocell) as important for post-BCMA CAR-T with improved safety.

Cagnoni confirmed PK, safety and efficacy together drove the stop, but would not commit to a precise IND date for the next-generation asset.

Pablo clarified Phase III was never paused. Phase I European enrollment held for administrative consent/IB amendments. 4 pneumonitis cases in 350+ patients, 3 with chemo, 2 with infections. In-depth review found no signal. US enrollment continued uninterrupted.

Steven confirmed 33-36% biologic-exposed patients. HiSCR response rates increase over time with excellent pain control and draining tunnel data. Seeking label in both pre- and post-biologic populations.

Pablo discussed CALR antibody development: Jakafi combo possible but not committed. Short Jakafi induction plus long-term CALR maintenance could be treatment paradigm. Noted differential activity for Type 1 vs Type 2 mutations.

Phipps asked whether the 7,000 new starts are all organic; Lewis confirmed 100% organic and said ready-and-waiting patients are gone.

Management acknowledged approval rates typically trend down over time but expressed confidence that focus on 2+ exacerbation patients means new policies won't materially reduce access. Some policies may actually accelerate approval.

CMO explained treatment paradigm escalation for COPD/asthma patients. If patients continue exacerbating despite optimal treatment including biologics, physicians should question if bronchiectasis is the underlying driver. Clinical suspicion and CT scan are the diagnostic pathway regardless of eosinophil levels.

COO confirmed majority of prescriptions are 25 mg dose. Lung function benefit resonating particularly with thought leader community. Some physicians starting at 10 mg with plans to titrate up, consistent with typical new medicine adoption patterns.

Roopal highlighted 859's preclinical potency and a half-life-extension design element that could support deeper coverage and less frequent (potentially once-weekly) dosing, with human data expected next year.

Roopal Thakkar highlighted bretisilocin's short hallucination duration (clinician-friendly), longer durability after just 1-2 doses (potential rewiring concept), and large deltas versus low-dose comparator in Phase II. Planning different doses and duration paradigms in Phase II, with potential expansion beyond MDD to other mood disorders.