Shares of vTv Therapeutics (VTVT, Financial) jumped 27.87% to $18.95 as of 9:53 AM ET after the company announced that the U.S. FDA has lifted the clinical hold on its late-stage trial for cadisegliatin, an oral treatment for type 1 diabetes.
The trial was previously halted due to an issue with chromatographic signal detection in a study analyzing how the drug is absorbed and processed. The company later determined that the signal was an experimental artifact, not a safety concern, leading the FDA to remove the hold as of March 14, 2025. To expedite development, vTv Therapeutics is shortening the trial duration from 12 months to 6 months via a protocol amendment, allowing for a quicker transition to pivotal studies required for a New Drug Application (NDA).
The primary endpoint—measuring level 2 and 3 hypoglycemia rates at 6 months remains unchanged, the company confirmed. Investor enthusiasm around the FDA decision has driven significant early trading gains for the stock.
