Phase 2 CELIA missed primary endpoint but cut tau and slowed decline
Biogen reported results from its Phase 2 study of Diranersen (BIIB080) for Early Alzheimer's disease on May 14, 2026. The results were mixed.
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- Company
- Biogen Inc. BIIB
- Drug
- Diranersen (BIIB080)
- For
- Early Alzheimer's disease
- Stage
- Phase 2 · the stage that tests whether the drug actually works
- When
- May 14, 2026
- Source note
- Biogen released topline results from the 18-month Phase 2 CELIA study of the tau-targeting ASO diranersen (BIIB080) in early Alzheimer's disease. The trial did not hit its primary endpoint, but Biogen said it would continue development based on slowing of clinical decline and reductions in brain tau.
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- Source: alz.org ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- BIIB headlines on this site
Biogen presents data on Litifilimab for Cutaneous lupus erythematosus at a medical meeting in the second half of 2026 (no exact date yet). New numbers at a conference can move the stock as much as a formal announcement.
More details
- Entry
- Litifilimab AMETHYST 52-week Phase 2 CLE data at EADV 2026 · Data presented at a medical meeting
- Drug
- Litifilimab
- For
- Cutaneous lupus erythematosus
- Stage
- Phase 2/3 · a combined mid- to late-stage study
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Biogen Q2 2026 earnings call (July 29, 2026): management plans to present 52-week Phase 2 AMETHYST CLE data at the EADV congress (fall 2026); exact month not stated by the company in the source.
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- Source: fool.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- BIIB headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Biogen expects to report results from its Phase 3 study of litifilimab (BIIB059, anti-BDCA2) for Systemic lupus erythematosus in Q4 2026 (Oct–Dec) (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
More details
- Entry
- Litifilimab Phase 3 TOPAZ-1 and TOPAZ-2 topline in systemic lupus · Clinical trial results (readout / topline data)
- Drug
- litifilimab (BIIB059, anti-BDCA2)
- For
- Systemic lupus erythematosus
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- Q4 2026 · the company gave a window, not a day
- Source note
- Biogen's Q2 2026 report (July 29, 2026) guides Phase 3 topline results from both TOPAZ SLE studies in the fourth quarter of 2026 — the company's most proximate binary pipeline event.
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- Source: investors.biogen.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- BIIB headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Biogen expects to report results from its Phase 3 study of litifilimab (BIIB059) for Cutaneous lupus erythematosus in the first half of 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
More details
- Entry
- Litifilimab Phase 3 cutaneous lupus (CLE) data · Clinical trial results (readout / topline data)
- Drug
- litifilimab (BIIB059)
- For
- Cutaneous lupus erythematosus
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H1 2027 · the company gave a window, not a day
- Source note
- Timing accelerated: Phase 3 CLE data now expected in the first half of 2027 (Biogen Q2 2026 business update).
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- Source: investors.biogen.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- BIIB headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Biogen expects to report results from its Phase 3 study of felzartamab (anti-CD38) for Antibody-mediated rejection in kidney transplant recipients in the first half of 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
More details
- Entry
- Felzartamab Phase 3 TRANSCEND data in antibody-mediated rejection · Clinical trial results (readout / topline data)
- Drug
- felzartamab (anti-CD38)
- For
- Antibody-mediated rejection in kidney transplant recipients
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H1 2027 · the company gave a window, not a day
- Source note
- Biogen accelerated expected Phase 3 TRANSCEND AMR data to the first half of 2027 (Q2 2026 business update).
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- Source: investors.biogen.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- BIIB headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page