Catalyst Monitor: Q1 2026 Outlook

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This report compiles published, predictive intelligence based on interviews with key opinion leaders (KOLs) on market-moving events that are expected to occur in Q1 2026.

GlobalData’s latest report, “Catalyst Monitor Q1 2026”, delivers forward-looking intelligence derived from interviews with key opinion leaders (KOLs), covering trial initiations, completions, top-line results, regulatory filings, PDUFA dates, and expected approvals. The report covers 13 significant catalyst events that are expected to occur in Q1 2026.

Some of the catalysts covered in the report, include approval decisions for GSK’s depemokimab in asthma and sinusitis, Regenxbio’s clemidsogene lanparvovec in Hunter syndrome, Omeros’ narsoplimab in thrombotic microangiopathy, and more.

Additionally, experts also discuss the ongoing clinical trials with Xenon Pharmaceuticals’ azetukalner for focal onset seizures, Cerevel's tavapadon for Parkinson's disease, Neumora's navacaprant for major depressive disorder (MDD), and more.
The Catalyst Monitor report is published on a quarterly basis. The data presented in this report reflects the database as of 24 December.

Scope

The Q1 Catalyst Monitor report offers exclusive forward-looking insights on Phase II and Phase III results, regulatory drug approvals and more, based on exhaustive research and exclusive KOL interviews.

Reasons to Buy

This report will enable the user to answer the following questions –

• Which biopharma companies are expecting major milestones such as FDA decisions or late-stage trial completions and results in Q1 2026?

• Which upcoming regulatory catalysts that are expected in Q1 2026 are likely to be market-moving events?

• How do the number of expected regulatory events like trial initiations and trial completions in Q1 2026 compare to the previous quarter?

• Which are the top therapy areas for market-moving catalysts in Q1 2026 compared to the previous quarter?

• Which companies have the highest numbers of upcoming catalysts expected in Q1 2026?

• How do KOLs assess the clinical and commercial prospects of Aldeyra’s reproxalap in Keratoconjunctivitis Sicca (Dry Eye), in a competitive disease space?

• How do KOLs assess the EU approval prospects of Omeros’s updated filing for narsoplimab in thrombotic microangiopathy, following a prior rejection?

• What are the expectations regarding Regenxbio’s clemidsogene lanparvovec approval in Hunter Syndrome and the translation of biomarkers into clinical outcomes?

Cerevel Therapeutics (AbbVie)
AstraZeneca
GSK
Xenon Pharmaceuticals
Regenxbio
Aldeyra Therapeutics
Avacta Group
IGC Pharma
Immunis
Neumora Therapeutics
iBio
Sangamo Therapeutics
Omeros Corp

Table of Contents

About GlobalData

Quarterly Catalyst Comparisons

Catalyst Calendar

Catalysts

Appendix

Table

Quarterly Catalyst Comparisons- Event Type

Quarterly Catalyst Comparisons- Therapy Area

Quarterly Catalyst Comparisons- Molecule Type

Quarterly Catalyst Company Breakdown

Catalyst Calendar

Catalyst Monitor: Q1 2026 Outlook standard reports
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