Shares for High Point-based vTv Therapeutic soared more than 53% on Monday in early trading after the company announced that the FDA had lifted the clinical hold on its late-stage trial for cadisegliatin, a potential adjunctive oral drug for the treatment of type 1 diabetes.
The FDA placed a clinical hold on the trial in July 2024 due to a chromatographic signal in how the drug was absorbed and processed. No patient had been dosed in the trial at the time of the clinical hold, and past clinical studies did not reveal any clinically concerning safety issues. The clinical hold was lifted on March 14, after it was concluded that the chromatographic signal was an experimental artifact, according to the company, which was founded in 2015.
“We are pleased that the FDA has lifted the clinical hold on our cadisegliatin program and are eager to resume our Phase 3 trial,” says CEO Paul Sekhri.
The drug is used as an adjunct therapy meant to maximize the effectiveness of insulin alone. Its aim is to help diabetics maintain blood sugar levels while avoiding incidents of low blood sugar levels, according to the company. The drug has been well-tolerated in more than 500 subjects to date, according to the company.
In a January 2025 presentation to investors, the company reported that 9.4 million people globally have type 1 diabetes and that if the drug were approved it would have the potential for gross sales in the $3 billion to $5 billion range annually.
In its 2023 annual report, the company reported it had 16 full-time employees, with nine of them working in North Carolina. Of its employees, seven worked full-time in research and development, and 10 had graduate degrees, including eight with doctorates.
Shares of vTv Therapeutics have traded between $12.12 and $30.99 in the past year, and closed Friday at $14.82. Shares closed Monday at $22.74, up $7.92 or 53.4%. Shares were up more than $10 or 69% midday. It has a market capitalization of $64 million.
In February 2024, vTv Therapeutics announced a $51 investment in private placement financing that included institutional investor Samsara BioCapital and JDRF, now known as Breakthrough T1D.
The company has reported losses ranging from $20.3 million in 2023 to $13 million in 2021. It has never reported a profit.