Today, investors in vTv Therapeutics (NASDAQ:VTVT) and VTVT stock are certainly happy campers. This stock is up more than 40% today on a key announcement.
This small, little-known biopharmaceutical company has a market capitalization of around $200 million at the time of writing. It’s a company focused on developing oral, small-molecule drug candidates for Type 1 diabetes and psoriasis. Additionally, the company expects additional applications for its pipeline could become feasible over the long term. Indeed, vTv is targeting other avenues for its drugs including pulmonary disease, renal disease and primary mitochondrial myopathy.
That’s all great, but let’s get to the key driver of today’s massive rally in VTVT stock.
VTVT Stock Surging on FDA Designation
Today, vTv announced that the U.S. Food and Drug Administration granted a breakthrough therapy designation for its TTP339 drug. This therapy works in conjunction with insulin for treatment of Type 1 diabetes. As one of the company’s core drugs, investors seem bullish on this announcement. The expectation is that this oral, once-daily glucokinase activator could provide expedited development and review timelines. This means the therapeutic medicine could be brought to market sooner than expected.
The FDA noted that “preliminary clinical evidence indicates that an investigational therapy may demonstrate substantial improvement on one or more significant endpoints relative to available therapies for a serious or life-threatening condition.”
That’s about as bullish a determination as investors could have expected from the FDA. It appears the trials undertaken by vTv showed statistically significant improvement relative to the placebo, and reduced severe and symptomatic hypoglycemia materially. Thus, the drug appears to be effective, based on initial results.
Given the impact hypoglycemia has on patients with Type 1 diabetes, this drug has a ton of potential right now. The CEO of vTv recently noted, “Hypoglycemia remains a leading cause of morbidity and potential mortality in the treatment of type 1 diabetes…We look forward to working with the FDA as we advance the development of TTP399, and in particular as we begin pivotal trials later this year.”
As far as clinical-stage biopharma companies go, vTv now appears to be a much safer bet today than yesterday. This announcement could be pivotal for the company, and today’s stock price rise appears to be warranted.
On the date of publication, Chris MacDonald did not have (either directly or indirectly) any positions in the securities mentioned in this article.