By Connor Hart
Shares of vTv Therapeutics tumbled after the Food and Drug Administration placed a clinical hold on the company's program studying a treatment for Type 1 diabetes.
After the bell, the stock was down 40% at $12.75. Shares ended the market trading session up 1% at $21.20, putting them up more than 84% since the beginning of the year.
The diabetes-focused biopharmaceutical company on Friday said the FDA's decision came after the discovery of a chromatographic signal in a recent human study of how the treatment--cadisegliatin--was absorbed, distributed, metabolized and excreted couldn't be resolved by standard mass spectroscopy.
The FDA requires a single in vitro study to characterize this signal before the cadisegliatin program, which includes the company's ongoing CATT1 Phase 3 trial in Type 1 diabetes, can resume, the High Point, N.C., company said.
Cadisegliatin is a novel, oral, small-molecule, liver-selective glucokinase activator with first-in-class potential as an adjunct treatment for Type 1 diabetes, the company said.
"We are working diligently with the Agency to resolve the clinical hold and resume enrollment as quickly as possible," Chief Executive Paul Sekhri said.
Write to Connor Hart at connor.hart@wsj.com
(END) Dow Jones Newswires
July 26, 2024 17:51 ET (21:51 GMT)
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