FDA accelerated approval of Aduhelm
The FDA approved Biogen’s Aduhelm (aducanumab) for Alzheimer's disease on Jun 7, 2021. The company can now sell it in that market.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Biogen Inc. BIIB
- Drug
- Aduhelm (aducanumab)
- For
- Alzheimer's disease
- When
- Jun 7, 2021
- Source note
- Controversial accelerated approval of aducanumab for Alzheimer's disease.
- Checked
- Checked by a person when it was added
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- 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.
- Checked
- Checked by a person when it was added
- Verify it
- 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.
- Checked
- Checked by a person when it was added
- Verify it
- 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).
- Checked
- Checked by a person when it was added
- Verify it
- 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).
- Checked
- Checked by a person when it was added
- Verify it
- 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