Catalyst Monitor: Q4 2025 Outlook

GlobalData's latest report, "Catalyst Monitor Q4 2025", 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 20 significant catalyst events that are expected to occur in Q4 2025.

Some of the catalysts covered in the report, include approval decisions for Cytokinetics's aficamten for obstructive hypertrophic cardiomyopathy, Aldeyra's reproxalap for keratoconjunctivitis sicca, GSK's depemokimab for chronic rhinosinusitis and asthma, and more.

Additionally, experts also discuss the ongoing clinical trials with Quoin Pharmaceuticals' QRX-003 for Netherton syndrome, Cogent Biosciences's bezuclastinib for systemic mastocytosis, Sanofi's tolebrutinib for Primary progressive multiple sclerosis (PPMS), and more.

The Catalyst Monitor report is published on a quarterly basis. The data presented in this report reflects the database as of 30 September.

This report compiles published, predictive intelligence based on interviews with key opinion leaders (KOLs) on market-moving events that are expected to occur in Q4 2025.

Scope

• The Q4 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 Q4 2025?
• Which upcoming regulatory catalysts that are expected in Q4 2025 are likely to be market-moving events?
• How do the number of expected regulatory events like trial initiations and trial completions in Q4 compare to the previous quarter?
• Which are the top therapy areas for market-moving catalysts in Q4 compared to the previous quarter?
• Which companies have the highest numbers of upcoming catalysts expected in Q4?
• What commercial impact could GSK's depemokimab have in the asthma therapeutics market if approved, based on Phase III data?
• What is the commercial and clinical significance of Cogent Biosciences' upcoming Phase III trial readout for bezuclastinib in systemic mastocytosis, and how might it compete with the existing therapeutic option?
• How do KOLs assess the clinical and commercial prospects of DBV's DBV-712 as a treatment for peanut allergies given its past regulatory history?
• What are expert views on Pfizer's Adcetris and how it may compete in the Diffuse Large B-cell Lymphoma (DLBCL) space?