Biogen Inc. BIIB
Biogen Inc. (Nasdaq: BIIB) is a CNS/neurology/psychiatry drug developer. Its lead program, Leqembi (lecanemab), is in Phase 3 for 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 | SMA | RNA (siRNA/ASO/mRNA) | Approved |
| Zurzuvae | Postpartum depression | small molecule | Approved |
| Syfovre/Empaveli | Geographic atrophy / PNH | protein/peptide | Approved |
| Litifilimab | SLE/CLE | antibody | Phase 3 |
| Dapirolizumab pegol | SLE | antibody | Phase 3 |
| Felzartamab | AMR/IgAN/PMN | antibody | Phase 3 |
| Salanersen | SMA | RNA (siRNA/ASO/mRNA) | Phase 3 |
| Zorevunersen | Dravet syndrome | RNA (siRNA/ASO/mRNA) | Phase 3 |
| Diranersen | not captured | RNA (siRNA/ASO/mRNA) | Phase 2 |
| BIIB091 | not captured | small molecule | Phase 2 |
| RayThera lead program | immunology | 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
5 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.