Biogen Inc. BIIB
Biogen Inc. (Nasdaq: BIIB) is a CNS/neurology/psychiatry drug developer. Its lead program, diranersen (BIIB080), is in Phase 3 for early Alzheimer's disease.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| LEQEMBI (lecanemab) | Alzheimer's disease | antibody | Approved |
| SPINRAZA (nusinersen) | spinal muscular atrophy | RNA (siRNA/ASO/mRNA) | Approved |
| SKYCLARYS | Friedreich's ataxia | small molecule | Approved |
| QALSODY | amyotrophic lateral sclerosis | RNA (siRNA/ASO/mRNA) | Approved |
| SYFOVRE (pegcetacoplan injection) | geographic atrophy | protein/peptide | Approved |
| diranersen (BIIB080) | early Alzheimer's disease | RNA (siRNA/ASO/mRNA) | Phase 3 |
| zorevunersen (BIIB151) | Dravet syndrome | RNA (siRNA/ASO/mRNA) | Phase 2 |
| BIIB091 | relapsing-remitting multiple sclerosis | small molecule | Phase 2 |
| litifilimab | cutaneous lupus erythematosus | antibody | Phase 2 |
| felzartamab | not specified | antibody | Phase 2 |
| salanersen (BIIB115) | spinal muscular atrophy | RNA (siRNA/ASO/mRNA) | Phase 1 |
| RayThera lead program | immune-mediated conditions | small molecule | Phase 1 |
Recent results and decisions
- Jul 29, 2026positive BIIB091 Phase 2 data in relapsing-remitting MS achieved proof-of-concept; Biogen will explore next steps for the asset. No figures given.
Today Biogen announced Phase 2 data for BIIB091 in relapsing-remitting multiple sclerosis, which showed that BIIB091 has achieved proof-of-concept and the Company will be exploring next steps for the asset.
Filing - Jul 29, 2026approval CEO cites the approval of LEQEMBI IQLIK at-home initiation (PDUFA had been May 24, 2026); approval date not stated in this release.
with a successful launch of SPINRAZA HD and historic approval of LEQEMBI IQLIK at-home initiation
Filing - Apr 29, 2026positive Second positive Phase 2 CLE dataset for litifilimab showed a meaningful reduction of disease activity at Week 16; no figures given.
Litifilimab second positive Phase 2 CLE dataset showed meaningful reduction of disease activity in people living with CLE at Week 16; if approved litifilimab could be the first targeted therapy for this disease
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 CNS/neurology/psychiatry 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.