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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
GlobeNewswire News Roomยท 2025-07-22 14:50
Core Insights - The "Catalyst Monitor: Q3 2025 Outlook" report provides forward-looking intelligence on significant catalyst events expected in Q3 2025, derived from interviews with key opinion leaders (KOLs) [1][3] - The report highlights 18 major catalyst events, including FDA approval decisions for various drugs targeting conditions such as adult growth hormone deficiency and wet age-related macular degeneration [2][4] Company and Industry Highlights - Ascendis Pharma's Skytrofa is under review for FDA approval for adult growth hormone deficiency [2] - PTC Therapeutics' sepiapterin is being evaluated for phenylketonuria, while Lenz Therapeutics' LNZ100 is aimed at treating presbyopia [2] - Eli Lilly's orforglipron is in ongoing clinical trials for obesity, and aTyr Pharma's efzofitimod is being studied for pulmonary sarcoidosis [3][4] - The report includes insights on the commercial impact of orforglipron in the GLP-1 market if approved, based on Phase III data [7] - KOLs assess the commercial potential of Lenz Therapeutics' LNZ100 in the context of existing non-pharmacological options for presbyopia [7] - Boehringer Ingelheim's Ofev is discussed regarding its potential expansion into pediatric interstitial lung disease amid safety concerns [7] Research Methodology - The report compiles predictive intelligence based on extensive research and exclusive interviews with KOLs, focusing on market-moving events expected in Q3 2025 [3][4] - It provides a comparative analysis of expected regulatory events, trial initiations, and completions in Q3 compared to the previous quarter [7]