Novartis AG NVS
Novartis AG (NYSE: NVS) is a cardio-renal-metabolic drug developer. Its lead program, Entresto (sacubitril/valsartan), is in Phase 3 for Heart failure (HFrEF, HFpEF, pediatric). Its next catalyst on record is delpacibart braxlosiran (del-brax): Planned FDA meeting on next steps in FSHD (date not stated).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: delpacibart braxlosiran (del-brax) — Planned FDA meeting on next steps in FSHD (date not stated). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Entresto | Heart failure | small molecule | Approved |
| Cosentyx | Not stated in extract | antibody | Approved |
| Kisqali | Not stated in extract | small molecule | Approved |
| Xolair | Not stated in extract | antibody | Approved |
| Mayzent | Not stated in extract | small molecule | Approved |
| Rydapt | Not stated in extract | small molecule | Approved |
| delpacibart zotadirsen (del-zota) | Duchenne muscular dystrophy, exon 44 skipping (DMD44) | RNA (siRNA/ASO/mRNA) | Phase 3 |
| delpacibart etedesiran (del-desiran) | Myotonic dystrophy type 1 | RNA (siRNA/ASO/mRNA) | Phase 3 |
| abelacimab | Stroke and systemic embolism prevention in atrial fibrillation | antibody | Phase 3 |
| pacibekitug | Atherosclerotic cardiovascular disease | antibody | Phase 3 |
| delpacibart braxlosiran (del-brax) | Facioscapulohumeral muscular dystrophy (FSHD) | RNA (siRNA/ASO/mRNA) | Phase 2 |
| farabursen | Autosomal dominant polycystic kidney disease | oligonucleotide-other | Phase 1 |
Recent results and decisions
- Sep 8, 2026missed HARBOR Phase III trial of del-desiran in DM1 did not show a statistically significant improvement vs placebo on the primary endpoint of video hand opening time (vHOT).
the global Phase III HARBOR study evaluating del-desiran in people living with myotonic dystrophy type 1 (DM1) did not demonstrate statistically significant improvement versus placebo on the primary endpoint of video hand opening time (vHOT)
Filing - Sep 8, 2026accepted Del-zota (DMD exon 44) was filed for accelerated approval and granted FDA priority review; PDUFA date not stated.
The company filed del-zota for accelerated approval and was granted priority review designation by US Food and Drug Administration (FDA).
Filing - Sep 8, 2026n/a FDA granted priority review designation for del-zota in DMD44.
The company filed del-zota for accelerated approval and was granted priority review designation by US Food and Drug Administration (FDA).
Filing
4 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.