Catalyst Monitor: Q3 2025 Outlook

Catalyst Monitor: Q3 2025 Outlook

Summary

GlobalData’s latest report, “Catalyst Monitor Q3 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 18 significant catalyst events that are expected to occur in Q3 2025.

Some of the catalysts covered in the report, include FDA approval decisions for Ascendis Pharma’s Skytrofa for adult growth hormone deficiency (GHD), PTC Therapeutics’ sepiapterin for phenylketonuria, Lenz Therapeutics’ presbyopia treatment LNZ100, Outlook Therapeutics’ Lytenava (bevacizumab-vikg) for wet age-related macular degeneration (AMD) and more.

Additionally, experts also discuss the ongoing clinical trials with Eli Lilly’s orforglipron for obesity, aTyr Pharma’s pulmonary sarcoidosis drug efzofitimod, amongst others.

The Catalyst Monitor report is published on a quarterly basis. The data presented in this report reflects the database as of June 20, 2025.

This report compiles published, predictive intelligence based on interviews with key opinion leaders (KOLs) on market-moving events that are expected to occur in Q3 2025.

Scope

• The Q3 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.

• Which biopharma companies are expecting major Q3 2025 milestones such as FDA decisions or late-stage trial completions and results?
• Which upcoming regulatory catalysts that are expected in Q3 2025 are likely to be market-moving events?
• How do the number of expected regulatory events like trial initiations and trial completions in Q3 compare to the previous quarter?
• Which are the top therapy areas for market-moving catalysts in Q3 compared to the previous quarter?
• Which companies have the highest numbers of upcoming catalysts expected in Q3?
• What commercial impact could orforglipron have in the GLP-1 market if approved, based on Phase III data?
• What is the commercial and clinical significance of aTyr Pharma’s upcoming Phase III EFZO-FIT trial readout for efzofitimod in pulmonary sarcoidosis, and how might it influence the treatment landscape?
• How do KOLs assess Lenz Therapeutics’ LNZ100’s commercial potential in presbyopia given the dominance of non-pharmacological options?
• What are expert views on Boehringer Ingelheim’s Ofev’s potential expansion in pediatric interstitial lung disease (ILD), amid safety concerns?