Tofersen

Approved

Biogen Inc. (BIIB)

00%

What is LOA?

Orphan DrugFast TrackBreakthrough TherapyLearn about designations

Approved

Development Phase

Upcoming Catalysts

Historical Events

Regulatory Approvals

Upcoming Catalysts

What are catalysts?

Q3 '27

BIIBPhase 3$33.1B

Tofersen Phase 3 Est. Readout

Tofersen• ALS (SOD1)158

BTDFTOrphan

Q3 2027~QConfirmed

CT.gov

00%

Jan '27

BIIBPhase 2$33.1B

Tofersen Phase 2 Est. Readout

Tofersen• ALS (SOD1)30

BTDFTOrphan

Jan 2027~Confirmed

CT.gov

00%

Competitive Landscape

1 competitor in ALS (SOD1)

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Drug Information

Target Indication

ALS (SOD1)

Mechanism of Action

Antisense Oligonucleotide

Clinical Trial

NCT02623699

Last updated: 12/3/2025

Patent & Exclusivity

ActiveRLD

Latest Patent Expiry

Apr 1, 2035(8y 6m)

Patents Listed

Exclusivity

NCEODE-432

Application

NDA 215887

Source: FDA Orange Book

Regulatory Approvals

EMA5/29/2024

Qalsody

Qalsody is indicated for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene.

Orphan

View on EMA

Drug Science

Mechanism of action & safety profile

Developer

BIIB

Biogen Inc.

Biological Products, (No Diagnostic Substances)•North America•NASDAQ

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