AMGN Amgen

Amgen dazodalibep Phase 3 OASIZ-301 Sjögren's data at ACR Convergence 2026

Amgen will present positive Phase 3 OASIZ-301 topline results for dazodalibep in Sjögren's disease with moderate-to-severe systemic activity at ACR Convergence on Nov 11 2026, showing statistically significant ESSDAI reductions and improvements in patient-reported dryness versus placebo with similar safety.

Amgen Tarlatamab Label Update Shortens Observation Period to 6-8 Hours

FDA approved a September 2026 update to the tarlatamab label shortening the post-dose observation period from 22-24 hours to 6-8 hours after the first two doses. Real-world data from 90 patients across OneOncology practices (including 30 outpatient) showed mostly low-grade CRS and ICANS, supporting feasibility of outpatient administration in community settings.

Amgen and NORD Launch Learning Collaborative for Rare Autoimmune Diseases

Amgen is sponsoring a 14-month pilot Learning Collaborative with NORD's Rare Disease Centers of Excellence. The initiative focuses on improving diagnosis and care pathways for IgG4-RD and Thyroid Eye Disease, with learnings applicable to other rare diseases. It advances the SPAARK alliance goal of reducing time to rare autoimmune disease diagnosis by 50% by 2036.

Amgen IMDELLTRA + IMFINZI Phase 3 DeLLphi-305 meets OS primary endpoint in 1L ES-SCLC maintenance

Phase 3 DeLLphi-305 interim results show tarlatamab plus durvalumab significantly improved overall survival (HR 0.42) and progression-free survival (HR 0.34) versus durvalumab alone in first-line maintenance for extensive-stage small cell lung cancer. Data were presented at ESMO 2026 and published in NEJM. Amgen plans to share results with global regulatory authorities.

AstraZeneca VOLGA Phase 3: perioperative durvalumab + neoadjuvant EV improves EFS/OS in MIBC

VOLGA Phase 3 trial reported positive topline results for perioperative IMFINZI plus neoadjuvant enfortumab vedotin versus radical cystectomy in cisplatin-ineligible/refusing MIBC patients. Primary endpoint EFS and key secondary OS both met with statistically significant and clinically meaningful improvements (HR 0.51 and 0.58). Data presented at ESMO 2026 and published in NEJM; already granted FDA Priority Review.

Amgen Positive Phase 3 Topline for Dazodalibep in Sjögren's Disease

Amgen reported positive Phase 3 topline results for dazodalibep in moderate-to-severe systemic Sjögren's disease. The drug met the primary endpoint with statistically significant and clinically meaningful improvement in systemic disease activity.

tarlatamab · NCT06814496 registry update

countries: {'total_sites': 2, 'us_sites': 2} → {'total_sites': 3, 'us_sites': 3}

tarlatamab · NCT07778316 registry update

countries: {'total_sites': 2, 'us_sites': 1} → {'total_sites': 9, 'us_sites': 3}

Amgen: TEZSPIRE Phase 3 CROSSING trial meets co-primary endpoints in EoE

The Phase 3 CROSSING trial of TEZSPIRE in eosinophilic esophagitis met both co-primary endpoints (histologic remission and dysphagia symptom improvement) and all key secondary endpoints at week 24, with results sustained through week 52. The safety profile remained consistent with approved indications. Full results will be shared with regulators and presented at an upcoming medical meeting.

Amgen Inc. · FDA warning letter: Drug Product/Misbranded, False & Misleading Claims

FDA (The Office of Prescription Drug Promotion (OPDP)) issued a warning letter to Amgen Inc. dated 2026-08-12: Drug Product/Misbranded, False & Misleading Claims.

Amgen: CHMP backs Repatha label expansion for primary CV prevention

CHMP issued a positive opinion recommending Repatha (evolocumab) for adults with established or high-risk ASCVD to reduce first MACE via LDL-C lowering. The opinion is based on the Phase 3 VESALIUS-CV trial showing 25 % relative risk reduction in 3-P MACE. European Commission decision is expected in the coming months.

Amgen: CHMP positive opinion for Repatha primary-prevention use

CHMP adopted a positive opinion to expand Repatha’s EU label to adults at high or established ASCVD risk for primary prevention of first MI or stroke. The opinion rests on the Phase 3 VESALIUS-CV trial showing statistically significant reductions in MACE. Final European Commission decision is expected in the coming months.

Amgen: EC approves IMDYLLTRA (tarlatamab) for ES-SCLC

The European Commission granted marketing authorization for IMDYLLTRA (tarlatamab) as monotherapy for adults with ES-SCLC who progressed after first-line platinum-based chemotherapy. Approval rests on the Phase 3 DeLLphi-304 trial showing a 40% reduction in risk of death and a 5.3-month median OS gain versus chemotherapy. This is the first T-cell engager approved for small cell lung cancer in Europe.

Amgen: Phase 3 TEPEZZA OBI meets primary endpoint in active TED

Amgen reported positive topline Phase 3 results for subcutaneous TEPEZZA (teprotumumab-trbw) via on-body injector in moderate-to-severe active Thyroid Eye Disease. The trial met its primary endpoint with a 76.7% proptosis response rate versus 19.6% for placebo (p<0.0001) and a mean proptosis reduction of -3.17 mm versus -0.80 mm (p<0.0001). The subcutaneous formulation demonstrated comparable efficacy to the approved IV formulation, with a safety profile consistent with the known profile of TEPEZZA IV.