FDA Lifts Clinical Hold On vTv Therapeutics' Phase 3 Diabetes Trial, Stock Surges

Core Viewpoint - The FDA has lifted the clinical hold on vTv Therapeutics Inc.'s cadisegliatin clinical program, allowing the company to resume its Phase 3 trial for type 1 diabetes [1][4]. Group 1: Clinical Trial Updates - vTv Therapeutics plans to submit a protocol amendment to shorten the CATT1 trial duration from 12 months to 6 months, facilitating quicker topline data collection and the initiation of larger pivotal studies for future NDA submissions [2][4]. - The primary endpoint of assessing level 2 and 3 hypoglycemia rates at 6 months will remain unchanged despite the trial duration reduction [3]. - The clinical hold was previously imposed due to unresolved chromatographic signals in an ADME study, which the FDA required to be characterized through an in vitro study before resuming the program [6]. Group 2: Market Reaction - Following the FDA's announcement, vTv Therapeutics' stock price increased by 66.70%, reaching $24.76 [6]. Group 3: Product Potential - Cadisegliatin is positioned to potentially become the first oral adjunctive therapy to insulin for type 1 diabetes, with ongoing evaluations focused on its effects on glycemic control and hypoglycemia incidence compared to insulin alone [5].