Amgen Inc. AMGN
Amgen Inc. (Nasdaq: AMGN) is a cardio-renal-metabolic drug developer. Its lead program, MariTide, is in Phase 3 for obesity/metabolic. Its next catalyst on record is TEZSPIRE (EoE indication): Regulatory submissions following positive Phase 3 CROSSING trial results (H1 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: TEZSPIRE (EoE indication) — Regulatory submissions following positive Phase 3 CROSSING trial results (H1 2027). 5 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Repatha | atherosclerotic cardiovascular disease (ASCVD) | antibody | Approved |
| ENBREL | rheumatoid arthritis | protein/peptide | Approved |
| BLINCYTO | acute lymphoblastic leukemia | antibody | Approved |
| EVENITY | osteoporosis | antibody | Approved |
| UPLIZNA | neuromyelitis optica spectrum disorder | antibody | Approved |
| TEPEZZA | thyroid eye disease | antibody | Approved |
| TEZSPIRE | eosinophilic esophagitis (EoE) | antibody | Phase 3 |
| IMDELLTRA/IMDYLLTRA + IMFINZI | extensive-stage small cell lung cancer (ES-SCLC) | antibody | Phase 3 |
| dazodalibep | Sjögren's disease | protein/peptide | Phase 3 |
| ABP 206 | biosimilar to OPDIVO (nivolumab) | antibody | Phase 3 |
| ABP 234 | biosimilar to KEYTRUDA (pembrolizumab) | antibody | Phase 3 |
| MariTide | obesity/metabolic | unclear | Phase 2 |
Recent results and decisions
- Nov 3, 2026accepted BLA for ABP 206 biosimilar to nivolumab has been submitted and accepted for FDA review with an expected action by the end of 2026.
The Biologics License Application (BLA) with the FDA has been submitted and accepted for review. The Company expects an FDA action on this BLA by the end of the year.
Filing - Nov 3, 2026submitted ABP 234 biosimilar to pembrolizumab has met primary and secondary endpoints in Phase 3 study; FDA submission awaiting file acceptance.
A randomized, double-blind combined pharmacokinetic/comparative clinical study of ABP 234 compared with KEYTRUDA® (pembrolizumab) in patients with advanced or metastatic non-squamous NSCLC has met both primary and secondary endpoints. We have submitted these results and are awaiting file acceptance
Filing - Oct 1, 2026met TEZSPIRE Phase 3 CROSSING study met primary and secondary endpoints in eosinophilic esophagitis, achieving histologic remission in 64.8%-68.9% of patients versus 3.5% for placebo.
TEZSPIRE dosed every four weeks achieved histologic remission at Week 24 in 64.8% and 68.9% of EoE patients receiving the 210 mg and 420 mg doses, respectively, vs 3.5% for placebo
Filing
2 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 cardio-renal-metabolic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.