ABBV · Company research

AbbVie Inc.

3 upcoming catalysts · 0 phase 2+ trials on file

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Upcoming catalysts

ApprovalABBVAbbVieH2 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.

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Entry

FDA decision SKYRIZI subcutaneous induction in Crohn's disease expected later in 2026 · Regulatory approval

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

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.

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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
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FDA decisionABBVAbbVieQ4 2026

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.

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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.

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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

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Trial resultsABBVAbbVie2027

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.

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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'.

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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
ABBV headlines on this site

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Past catalysts

Trial resultsABBVAbbVieJul 23, 2026

AbbVie reported results from its Phase 3 study of epcoritamab (TEPKINLY/EPKINLY) for Relapsed/refractory diffuse large B-cell lymphoma on Jul 23, 2026. The study missed its main goal.

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EPCORE DLBCL-1: US primary endpoint of overall survival was not met · Clinical trial results (readout / topline data)

Drug

epcoritamab (TEPKINLY/EPKINLY)

For

Relapsed/refractory diffuse large B-cell lymphoma

Stage

Phase 3 · the last stage before a drug can be approved

When

Jul 23, 2026

Source note

Genmab and AbbVie issued a clarification that overall survival was the sole U.S. primary endpoint of the confirmatory Phase 3 EPCORE DLBCL-1 trial of epcoritamab and that it was not met.

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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
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

Trial resultsABBVAbbVieJun 29, 2026

AbbVie reported results from its Phase 3 study of epcoritamab (TEPKINLY) + lenalidomide for Relapsed/refractory diffuse large B-cell lymphoma on Jun 29, 2026. The study met its main goal.

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Entry

Phase 3 EPCORE DLBCL-4 met primary endpoint; 60% cut in progression or death · Clinical trial results (readout / topline data)

Drug

epcoritamab (TEPKINLY) + lenalidomide

For

Relapsed/refractory diffuse large B-cell lymphoma

Stage

Phase 3 · the last stage before a drug can be approved

When

Jun 29, 2026

Source note

Epcoritamab plus lenalidomide beat R-GemOx in relapsed/refractory DLBCL with a hazard ratio of 0.40 (p<0.0001) on the primary endpoint.

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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
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

ApprovalABBVAbbVieJun 26, 2026

The FDA approved AbbVie’s SKYRIZI (risankizumab-rzaa) for Pediatric plaque psoriasis and psoriatic arthritis on Jun 26, 2026. The company can now sell it in that market.

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Entry

FDA approves SKYRIZI for pediatric plaque psoriasis and psoriatic arthritis · Regulatory approval

Drug

SKYRIZI (risankizumab-rzaa)

For

Pediatric plaque psoriasis and psoriatic arthritis

Stage

Regulatory (sBLA)

When

Jun 26, 2026

Source note

Approval covers children six years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, or with active psoriatic arthritis.

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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

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ApprovalABBVAbbVieMay 27, 2026

The FDA approved AbbVie’s DECNUPAZ (pivekimab sunirine-pvzy) for Blastic plasmacytoid dendritic cell neoplasm on May 27, 2026. The company can now sell it in that market.

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Entry

FDA approves DECNUPAZ (pivekimab sunirine) for BPDCN · Regulatory approval

Drug

DECNUPAZ (pivekimab sunirine-pvzy)

For

Blastic plasmacytoid dendritic cell neoplasm

Stage

Regulatory (BLA)

When

May 27, 2026

Source note

First and only ADC approved for blastic plasmacytoid dendritic cell neoplasm that can be initiated in an outpatient setting, and AbbVie's first ADC approval in blood cancers. Carries a boxed warning for hepatotoxicity.

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Source: biospace.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

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Not approvedABBVAbbVieApr 23, 2026

The FDA told AbbVie it won’t approve trenibotulinumtoxinE (TrenibotE) for Glabellar lines (aesthetics) yet (Apr 23, 2026). The letter lists what has to be fixed before the application can be approved; many drugs get there after a resubmission.

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Entry

CRL for trenibotulinumtoxinE BLA over manufacturing process · FDA complete response letter (CRL)

Drug

trenibotulinumtoxinE (TrenibotE)

For

Glabellar lines (aesthetics)

Stage

Regulatory (BLA)

When

Apr 23, 2026

Source note

FDA issued a Complete Response Letter for the TrenibotE BLA. AbbVie said the letter concerned manufacturing process matters only, with no safety or efficacy issues raised and no additional clinical studies requested.

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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

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsABBVAbbVieMar 2, 2026

AbbVie reported results from its Phase 3 study of SKYRIZI (risankizumab) subcutaneous induction for Moderately to severely active Crohn's disease on Mar 2, 2026. The study met its main goal.

More details

Entry

Phase 3 AFFIRM met endpoints for SKYRIZI subcutaneous induction in Crohn's · Clinical trial results (readout / topline data)

Drug

SKYRIZI (risankizumab) subcutaneous induction

For

Moderately to severely active Crohn's disease

Stage

Phase 3 · the last stage before a drug can be approved

When

Mar 2, 2026

Source note

Subcutaneous risankizumab induction beat placebo at week 12 on clinical remission (55% vs 30%) and endoscopic response (44% vs 14%) in 289 patients, 65% of whom had failed prior advanced therapy.

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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
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

Things of Interest

Explore reported politician transactions and public investor statements connected to ABBV.

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Pipeline trials

ClinicalTrials.gov · phase 2 and later

No phase 2+ trials cached for this company.

Company news

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