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PDUFAApproval decision

SKYRIZI/Risankizumab (N/A) (IL-23 Inhibitor)

Crohn's Disease

ABBVAbbVie
Expected catalystDecember 31, 2026Company guidance: Dec 31, 2026

Catalyst overview

Event details

Drug or asset
SKYRIZI/Risankizumab (N/A) (IL-23 Inhibitor)
Development stage
PDUFA
Event type
Approval decision
Indication
Crohn's Disease

Research summary

What is being tracked?

This catalyst tracks a PDUFA approval decision for SKYRIZI/Risankizumab (N/A) (IL-23 Inhibitor) in Crohn's Disease. The expected timing is based on the latest available company guidance and may change.

Development notes

03/02/26:- AFFIRM Ph3 (NCT06063967) topline positive; SC induction superior vs placebo at Week 12. Full results later. 04/27/26:- FDA filing for SC induction; AbbVie anticipates approval later in 2026. 05/05/26:- DDW posters show ASPIRE-CD year 1 symptom and QoL gains; US claims show low switching.

Verification

Primary source

Confirm timing and program details against the company announcement or filing.

Open source

Company

AbbVie

ABBV · NYSE
Industry
Biotechnology
Pipeline assets
64
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Updated Aug 23, 2026. Dates can change; this is not investment advice.

Disclaimer: Biotech Stock Intel is an independent research platform. Information is provided for informational purposes only and is not investment or medical advice. Always verify catalyst dates against primary sources and conduct your own research.
Biotech Stock Intel© 2026 Biotech Stock Intel
AboutMethodologyTermsPrivacy