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Phase II and Phase III Catalyst Monitor: Q3 2025 Outlook Report - Upcoming FDA Decisions Drive Momentum in Biopharma with Key Catalysts Across GHD, PKU, Presbyopia, and Wet AMD Treatments

1. The report outlines 18 significant catalyst events for Q3 2025. 2. FDA decisions include Outlook Therapeutics' AMD treatment Lytenava. 3. The report highlights key opinion leaders' insights on market-moving events. 4. Focus on clinical trial results and regulatory approvals across biopharma. 5. Insights may impact investments in relevant biopharma companies.

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Why Neutral?

The report discusses AMD treatments but lacks direct AMD developments affecting price.

How important is it?

The report addresses AMD, but competitive and regulatory insights temper direct impact.

Why Long Term?

AMD treatment developments can take time to impact market dynamics significantly.

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VRTXEli Lilly
Dublin, July 22, 2025 (GLOBE NEWSWIRE) -- The "Catalyst Monitor: Q3 2025 Outlook" report has been added to ResearchAndMarkets.com's offering.The report 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. This report will enable the user to answer the following questions: 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? Key Topics Covered: About the AnalystQuarterly Catalyst ComparisonsCatalyst CalendarCatalystsAppendix List of Tables Quarterly Catalyst Comparisons- Event TypeQuarterly Catalyst Comparisons- Therapy AreaQuarterly Catalyst Comparisons- Molecule TypeQuarterly Catalyst Company BreakdownCatalyst Calendar A selection of companies mentioned in this report includes, but is not limited to: Wave Life SciencesEli LillyAscendis PharmaPTC TherapeuticsSFA TherapeuticsVLP TherapeuticsaTyr PharmaKyverna TherapeuticsGeneluxLenz TherapeuticsBoehringer IngelheimOutlook TherapeuticsAnavex Life SciencesBiomea FusionSun PharmaceuticalAstraZeneca For more information about this report visit https://www.researchandmarkets.com/r/g0n7b8 About ResearchAndMarkets.comResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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