A High Point-based biotechnology company saw its stock fall by more than 35% in after-hours trading on Friday after it disclosed that the U.S. Food and Drug Administration had halted a test of its diabetes drug.
VTV Therapeutics said in a Form 8-K filing filed after the market closed on Friday that the FDA had stopped its phase three trial for its drug to treat type 1 diabetes because a “chromatographic signal” could not be resolved.
The agency requires a single in vitro study to characterize this signal before the program can resume. No patient had been dosed at the time of the clinical hold, and past clinical studies did not reveal any clinically concerning safety issues.
The drug that VTV is analyzing, Cadisegliatin, is an oral, liver selective, glucokinase activator that the company says has been well-tolerated in more then 500 subjects to date. Their treatment has lasted up to six months.
“Patient safety is our top priority, and we appreciate the thoroughness of the FDA to better understand this signal,” said CEO Paul Sekhri in a statement. “We are working diligently with the Agency to resolve the clinical hold and resume enrollment as quickly as possible.”
VTV Therapeutics shares fell $7.61 to $13.59 in after-hours trading on Friday. Its 52-week high is $31.20.
In February, the company saw its stock price more than double after two well-known health care investors put up a combined $51 million.
More than 18 million people live with type 1 diabetes worldwide with fewer than 30% meeting their A1c targets. The A1c test — also known as the hemoglobin A1c or HbA1c test — is a simple blood test that measures average blood sugar levels over the past 3 months.
vTv Therapeutics, previously known as TransTech Pharma, went public in 2015. It once tried to develop an Alzheimer’s drug Azeliragon. Billionaire investor Ronald Perelman owns more than 57% of the company through his MacAndrews & Forbes firm.
Perelman’s ownership of vTv has added allure to the company, but it’s been a slog for long-term investors. Shares topped $100 in 2020 and 2021.
Source link
