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Biogen (BIIB) pipeline and stated timing

Name in SEC filings: BIOGEN INC.

Pipeline at a glance

ProgramEventStageStated timingFiling
litifilimab/data readoutStage not statedend of 20268-K ·

Source: ORION, orionbiotechai.com/company/BIIB, data as of Oct 18, 2026
https://www.orionbiotechai.com/company/BIIB

Nearest upcoming stated timing: litifilimab · Topline/data readout · end of 2026

SEC sources last checked .

Programs and stated timing

○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.

How this date was described over time

Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of .

Program / eventStated period and SEC wordingDisclosure in stated period
litifilimabClinical resultsend of 2026
“Registrational data for litifilimab in SLE expected by end of 2026”

Filed · EX-99.1

Not compared

ORION has no confirmed start and end dates for this wording, so it is not compared with filings.

litifilimabClinical results2026
“data now expected in 2026 from both SLE studies for litifilimab which are fully enrolled.”

Filed · EX-99.1

Not compared

ORION has no confirmed start and end dates for this wording, so it is not compared with filings.

“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.

Retained company announcements

Historical summaries and source dates are retained separately from the SEC timing quotes above. Earlier publications were collected retrospectively.

Historical catalog checked .

Tofersen US FDA review

Tofersen application accepted for FDA review

Source published · Original announcement

Retained timing label: 2023-01-25

Retained summary: Biogen reported FDA acceptance and priority review of the tofersen application, with a target action date of January 25, 2023. Acceptance for review was not approval.

Retained source and collection times
Event effective
UNAVAILABLE
ORION first seen
ORION ingested

Tofersen FDA review extended by three months

Source published · Original announcement

Retained timing label: 2023-04-25

Retained summary: Biogen announced a new FDA target of April 25, 2023. It said responses to FDA information requests were considered a major amendment requiring additional review time.

Retained source and collection times
Event effective
ORION first seen
ORION ingested

Partner Ionis: QALSODY approval announcement

Source published · Original announcement

Retained summary: Ionis announced that its partner Biogen received accelerated FDA approval for QALSODY in adults with SOD1-associated ALS. The approval used a biomarker endpoint; continued approval could depend on confirmation of clinical benefit.

Retained source and collection times
Event effective
ORION first seen
ORION ingested

Read the retained source trail

Selected registry record

Litifilimab · NCT05531565

Condition in the selected registry record
Subacute Cutaneous Lupus Erythematosus
Phase in the selected registry record
Phase 2 / Phase 3
Identity checked

Original ClinicalTrials.gov record · Open the selected study

Retained company–study identity sources

Scope of retained company and registry evidence

These are selected linked records and dated source metadata, not a live registry recheck or the company’s full pipeline. Company announcements and the selected registry study are separate evidence sets. No stage or event timing is borrowed between them.

Coverage and identity checks

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Reading these records

First stated window
The timing wording in the earliest company statement located within the sources checked, quoted as written (for example “2H 2026”). An earlier statement may exist outside those sources.
Disclosure date
The date of the filing or company release that disclosed the readout. “None found” means no such disclosure was located in the sources checked. SEC filings were searched through the “SEC filings searched through” date shown.
1H, 2H, 1Q–4Q
First or second half, or first to fourth quarter, of the year named, as the company wrote it. Equivalent notations are compared together; the original wording stays visible.
SEC original
The filing as published on the SEC EDGAR system. “Company original” is the release on the company's own investor site.
Status
One of seven labels set by founder review of the original filings. Definitions: Methodology.

See BIIB in the calendar · Review labels and methodology

Topline results are the main summary results of a clinical trial, released before the full data.