Biogen Inc (BIIB) — Upcoming Catalysts

FDA PDUFA dates, advisory-committee meetings, and Phase 2/3 readout windows for Biogen Inc, built from public data lanes (ClinicalTrials.gov and official sources). Each row links to its source.

For informational purposes only — not investment advice. Track BIIB live on Mooboard →

This week2

  • Sep 27, 2026
    Biogen Inc(BIIB)Phase 2/3 readout
    Litifilimab · Phase 3 · Lupus Erythematosus, Systemic
    NCT04961567: A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus. Primary completion 2026-09-27 (estimated); status ACTIVE_NOT_RECRUITING.
    ClinicalTrials.gov ↗
  • Sep 30, 2026
    Biogen Inc(BIIB)Phase 2/3 readout
    Litifilimab · Phase 3 · Lupus Erythematosus, Systemic
    NCT04895241: A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus. Primary completion 2026-09-30 (estimated); status ACTIVE_NOT_RECRUITING.
    ClinicalTrials.gov ↗

Next 30 days1

  • Oct 20, 2026
    Biogen Inc(BIIB)Phase 2/3 readout
    Litifilimab · Phase 2 / Phase 3 · Subacute Cutaneous Lupus Erythematosus; Chronic Cutaneous Lupus Erythematosus
    NCT05531565: A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus. Primary completion 2026-10-20 (estimated); status ACTIVE_NOT_RECRUITING.
    ClinicalTrials.gov ↗

31–90 days1

  • Dec 1, 2026
    Biogen Inc(BIIB)Phase 2/3 readout
    Felzartamab · Phase 3 · Antibody-mediated Rejection
    NCT06685757: A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR). Primary completion 2026-12-01 (estimated); status ACTIVE_NOT_RECRUITING.
    ClinicalTrials.gov ↗

Later15

  • May 20, 2027
    Biogen Inc(BIIB)Phase 2/3 readout
    BIIB017 (peginterferon beta-1a) · Phase 3 · Multiple Sclerosis, Relapsing-Remitting
    NCT03958877: A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis. Primary completion 2027-05-20 (estimated); status ACTIVE_NOT_RECRUITING.
    ClinicalTrials.gov ↗
  • May 31, 2027
    Biogen Inc(BIIB)Phase 2/3 readout
    Felzartamab · Phase 3 · Immunoglobulin A Nephropathy (IgAN)
    NCT06935357: A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN). Primary completion 2027-05-31 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Aug 7, 2027
    Biogen Inc(BIIB)Phase 2/3 readout
    Tofersen · Phase 3 · Amyotrophic Lateral Sclerosis Associated With a SOD1 Gene Mutation
    NCT04856982: A Study of BIIB067 (Tofersen) Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation. Primary completion 2027-08-07 (estimated); status ACTIVE_NOT_RECRUITING.
    ClinicalTrials.gov ↗
  • Sep 24, 2027
    Biogen Inc(BIIB)Phase 2/3 readout
    Nusinersen · Phase 3 · Spinal Muscular Atrophy
    NCT05067790: A Study to Learn About the Effect of Higher Doses of Nusinersen (BIIB058) Given as Injections to Participants With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Risdiplam (ASCEND). Primary completion 2027-09-24 (estimated); status ACTIVE_NOT_RECRUITING.
    ClinicalTrials.gov ↗
  • Nov 16, 2027
    Biogen Inc(BIIB)Phase 2/3 readout
    Omaveloxolone · Phase 3 · Friedreich Ataxia
    NCT06953583: A Study to Learn More About the Effects and Long-Term Safety of Omaveloxolone (BIIB141) in Children and Teens With Friedreich's Ataxia. Primary completion 2027-11-16 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Jan 31, 2028
    Biogen Inc(BIIB)Phase 2/3 readout
    Felzartamab · Phase 2 · Graves' Disease
    NCT07722546: A Study to Learn About The Effects of Felzartamab on Thyroid Function and Its Safety in Adults With Graves' Disease Ages 18 to 75 Years Old. Primary completion 2028-01-31 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Feb 10, 2028
    Biogen Inc(BIIB)Phase 2/3 readout
    Felzartamab · Phase 2 · Microvascular Inflammation
    NCT07219043: A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation. Primary completion 2028-02-10 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Jun 23, 2028
    Biogen Inc(BIIB)Phase 2/3 readout
    Salanersen · Phase 3 · Spinal Muscular Atrophy
    NCT07444476: A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety in Participants Aged 15 to 60 Years With Spinal Muscular Atrophy (SMA) Who Are Either New to SMA Treatment or Were Previously Treated With Risdiplam. Primary completion 2028-06-23 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Nov 28, 2028
    Biogen Inc(BIIB)Phase 2/3 readout
    Salanersen · Phase 3 · Muscular Atrophy, Spinal
    NCT07221669: A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety When Given Before Symptoms Appear in Babies With Genetically Diagnosed Spinal Muscular Atrophy (SMA). Primary completion 2028-11-28 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Jun 26, 2029
    Biogen Inc(BIIB)Phase 2/3 readout
    BIIB059 (litifilimab) · Phase 3 · Subacute Cutaneous Lupus Erythematosus; Chronic Cutaneous Lupus Erythematosus
    NCT06044337: A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus. Primary completion 2029-06-26 (estimated); status ENROLLING_BY_INVITATION.
    ClinicalTrials.gov ↗
  • Jul 27, 2029
    Biogen Inc(BIIB)Phase 2/3 readout
    Salanersen · Phase 3 · Muscular Atrophy, Spinal
    NCT07444450: A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Onasemnogene Abeparvovec. Primary completion 2029-07-27 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Jan 28, 2030
    Biogen Inc(BIIB)Phase 2/3 readout
    Felzartamab · Phase 3 · Primary Membranous Nephropathy
    NCT06962800: A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN). Primary completion 2030-01-28 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • May 28, 2031
    Biogen Inc(BIIB)Phase 2/3 readout
    Felzartamab · Phase 3 · Antibody-mediated Rejection; Microvascular Inflammation
    NCT07444489: A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) or Microvascular Inflammation (MVI) (TRANSCEND/TRANSPIRE LTE). Primary completion 2031-05-28 (estimated); status ENROLLING_BY_INVITATION.
    ClinicalTrials.gov ↗
  • May 3, 2032
    Biogen Inc(BIIB)Phase 2/3 readout
    Litifilimab · Phase 3 · Systemic Lupus Erythematosus (SLE)
    NCT05352919: A Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and it's Effects on Symptoms in Adults With Systemic Lupus Erythematosus (SLE). Primary completion 2032-05-03 (estimated); status ENROLLING_BY_INVITATION.
    ClinicalTrials.gov ↗
  • Jul 28, 2034
    Biogen Inc(BIIB)Phase 2/3 readout
    Diroximel Fumarate · Phase 3 · Relapsing Forms of Multiple Sclerosis
    NCT07483632: A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS). Primary completion 2034-07-28 (estimated); status NOT_YET_RECRUITING.
    ClinicalTrials.gov ↗

How Biogen Inc has moved — past-year price reactions

How binary is BIIB? Its typical daily move, how often it swings ±10%, and its biggest single-day moves over the last year — useful context for sizing around a catalyst.

1.3%
typical day (1Y)
1
±10% days
35.3%
annualized vol
249
trading days
Largest single-day moves
  • +10.1%2025-10-01no matched headline
  • +8.5%2026-02-06no matched headline
  • -8.2%2026-07-14no matched headline
  • +7%2026-06-26no matched headline
  • -6.4%2026-05-14no matched headline
  • +6%2026-04-29no matched headline

Real daily price moves over the past year — not every move is a catalyst, and headlines (where shown) are a possible same-day driver, not confirmed causation.

Biogen Inc — active clinical pipeline

Biogen Inc's registered Phase 1–3 programs by asset and indication, derived from ClinicalTrials.gov.

14 assets24 programsPh1 6Ph2 3Ph3 14· 1 post-marketing (Ph4)
AreasAutoimmuneImmunologyNeuroscienceRare / GeneticOther
FelzartamabImmunology · CD38
Phase 2
Graves' DiseaseMicrovascular Inflammation
Phase 3
Antibody-mediated Rejection (2)Immunoglobulin A Nephropathy (IgAN)Primary Membranous Nephropathy
LitifilimabAutoimmune · CLEC4C
Phase 3
Lupus Erythematosus, Systemic (2)Subacute Cutaneous Lupus ErythematosusSystemic Lupus Erythematosus (SLE)
NusinersenRare / Genetic
Phase 1
Muscular Atrophy, Spinal
Phase 3
Spinal Muscular Atrophy
OmaveloxoloneOther · NFE2L2
Phase 1
Friedreich Ataxia
Phase 3
Friedreich Ataxia
SalanersenRare / Genetic
Phase 3
Muscular Atrophy, Spinal (2)Spinal Muscular Atrophy
BIIB017 (peginterferon beta-1a)Neuroscience
Phase 3
Multiple Sclerosis, Relapsing-Remitting
BIIB059 (litifilimab)Autoimmune
Phase 3
Subacute Cutaneous Lupus Erythematosus
Diroximel FumarateNeuroscience · KEAP1
Phase 3
Relapsing Forms of Multiple Sclerosis
TofersenNeuroscience · SOD1 mRNA
Phase 3
Amyotrophic Lateral Sclerosis Associated With a SOD1 Gene Mutation
DiranersenNeuroscience
Phase 2
Mild Cognitive Impairment Due to Alzheimer's Disease
BIIB115Other
Phase 1
Muscular Atrophy, Spinal
BIIB142Other
Phase 1
Healthy volunteers
BIIB144Other
Phase 1
Healthy volunteers
BIIB145Other
Phase 1
Healthy volunteers

Active registered Phase 1–3 trials from ClinicalTrials.gov — not the company's official IR pipeline (no preclinical or undisclosed assets). Grouped by trial intervention name; therapeutic area is auto-categorized. Each indication links to its trial. Molecular targets sourced from ChEMBL (EMBL-EBI).

Targets from a ChEMBL (EMBL-EBI) snapshot dated 2026-08-20 · 310/1701 assets resolved when it was built

See the full biopharma catalyst calendar across all covered companies.