By Katherine Hamilton

Shares of vTv Therapeutics rose after the Food and Drug Administration lifted a clinical hold on its diabetes treatment program.

The stock gained 40% to $20.78 Monday morning. Shares have climbed almost 50% in 2025.

The High Point, N.C., biopharmaceutical company said Monday it expects to resume its cadisegliatin clinical program, including a Phase 3 trial in type 1 diabetes. The FDA had placed a hold on the trial after discovering a chromatographic signal in a human absorption, distribution, metabolism and excretion study of cadisegliatin.

VTv submitted a response letter concluding that the chromatographic signal was an experimental artifact and the FDA lifted the hold Friday.

Before resuming the trial, vTv plans to submit a protocol amendment to reduce the overall duration of the trial to six months from 12 months to expedite the initiation of required larger pivotal studies for future New Drug Application submissions. By shortening the trial, vTv can collect topline data from the study more quickly, it said. The planned change will not include the additional six-month period to collect safety data, vTv said.

Cadisegliatin is an oral, liver selective glucokinase activator that's being investigated as an adjunctive treatment to insulin for type 1 diabetes. The company announced the Phase 3 trial in July. No patient had been dosed at the time of the clinical hold and past clinical studies did not reveal any concerning safety issues, vTv said.

Write to Katherine Hamilton at katherine.hamilton@wsj.com

(END) Dow Jones Newswires

March 17, 2025 11:01 ET (15:01 GMT)

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