FDA decision SKYRIZI subcutaneous induction in Crohn's disease expected later in 2026
AbbVie expects the FDA to decide on SKYRIZI (risankizumab) for Moderately to severely active Crohn's disease, SC induction regimen in the second half of 2026 (no exact date yet). An approval lets the company start selling it in that market.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- AbbVie Inc. ABBV
- Drug
- SKYRIZI (risankizumab)
- For
- Moderately to severely active Crohn's disease, SC induction regimen
- Stage
- sBLA
- When
- H2 2026 · the company gave a window, not a day; the calendar never invents one
- Source note
- AbbVie April 27, 2026 submission release (as reproduced by StockTitan); on the Q2 2026 earnings call management said it expected approval 'this fall' with a review on track and no manufacturing concerns.
- Checked
- Checked by a person when it was added
- Source: news.abbvie.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
- Drugs@FDA ↗ — search the drug name for approval letters
- ABBV headlines on this site
The FDA is expected to decide in Q4 2026 (Oct–Dec) (no exact date yet) whether to approve AbbVie’s RINVOQ (upadacitinib) for Non-segmental vitiligo (adults and adolescents). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
More details
- Entry
- Estimated FDA decision on RINVOQ for non-segmental vitiligo · FDA decision due (PDUFA date)
- Drug
- RINVOQ (upadacitinib)
- For
- Non-segmental vitiligo (adults and adolescents)
- Stage
- sNDA under review
- When
- Q4 2026 · the company gave a window, not a day
- Source note
- AbbVie submitted to FDA and EMA on February 3, 2026 based on the Phase 3 Viti-Up program; the EU has since approved. pdufa.bio estimates a Q4 2026 US action date; AbbVie has not disclosed the exact PDUFA date.
- Checked
- Checked by a person when it was added
- Verify it
- Source: pdufa.bio ↗ — where this entry was taken from
- 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
- ABBV headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
AbbVie expects to report results from its Early clinical study of ABBV-1758 for Alzheimer's disease during 2027 (no exact date yet). This is the first look at whether the drug did what the company hoped.
More details
- Entry
- ABBV-1758 brain-shuttle Alzheimer's antibody data expected in 2027 · Clinical trial results (readout / topline data)
- Drug
- ABBV-1758
- For
- Alzheimer's disease
- Stage
- Early clinical
- When
- 2027 · the company gave a window, not a day
- Source note
- AbbVie Q2 2026 earnings call (July 31, 2026) per Investing.com/GuruFocus highlights: brain-shuttle asset with >1% CSF penetration and potential monthly SC dosing; data expected in 2027. Same call flagged oral IL-23R inhibitor ABBV-8859 psoriasis data also 'expected next year'.
- 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
- ABBV headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page