vTv Therapeutics (VTVT, Financials) surged 42.99% to $21.23 on Monday after the U.S. Food and Drug Administration lifted a clinical hold on the company's development program for cadisegliatin, an experimental oral therapy for type 1 diabetes.

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Following an adjustment to cut its length from 12 months to six months, the business intends to start its Phase 3 CATT1 study. According to a statement by vTv Therapeutics, the updated schedule seeks to hasten the gathering of topline data and speed future regulatory filings.Designed as an oral supplement to insulin treatment, cadisegliatin is a glucokinase activator specific for the liver. The business claims that the medicine has been generally well tolerated after testing over 500 people for up to six months.Following a chromatographic signal in a metabolism study not able to be resolved with conventional mass spectrometry, the FDA has put a clinical halt on the experiment in July 2024. At the time, no patients had been registered for the experiment; earlier research had not shown any appreciable safety issues. Following vTv's entire response to the FDA, which indicated the signal was an experimental artifact, the clinical hold was released March 14.The main endpoint, which gauges degrees of moderate to severe hypoglycemia at six months, will not change with the adjustment to the research protocol. The revised scheme eliminates an extra six-month safety monitoring period, however.Late-stage biopharmaceutical business vTv Therapeutics is studying cadisegliatin as a first-in-class type 1 diabetes treatment.

The business has not said when it hopes to release topline findings from the CATT1 study.