VTVT - vTv Therapeutics shares surge as TTP399 wins FDA 'Breakthrough Therapy' status

vTv Therapeutics (VTVT) announces that the U.S. FDA has granted Breakthrough Therapy designation for TTP399 as an adjunctive therapy to insulin for the treatment of type 1 diabetes.Shares up more than 21% premarket.Breakthrough Therapy designation provides a sponsor with added support and the potential to expedite development and review timelines for a promising new investigational medicine.The status grant for the treatment was supported by recent positive results from the phase 2 SimpliciT-1 Study, a multi-center, randomized, double-blind, adaptive study assessing the safety and efficacy of TTP399.In the trial, treatment with TTP399 resulted in a statistically significant improvement in HbA1c relative to placebo and a clinically meaningful decrease (40%) in the frequency of severe and symptomatic hypoglycemia.vTv had announced the initiation of a mechanistic study exploring the effects of TTP399 on ketone body formation during a period of insulin withdrawal in people with type 1 diabetes, last month.

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vTv Therapeutics shares surge as TTP399 wins FDA 'Breakthrough Therapy' status