vTv Therapeutics Inc. VTVT announced that the FDA has granted Breakthrough Therapy designation to its oral, investigational once-daily glucokinase activator, TTP399, as an adjunctive therapy to insulin for the treatment of type I diabetes.
Shares of vTv Therapeutics were up 33.9% following announcement of the news on Tuesday. In fact, the stock has rallied 84.9% so far this year against the industry’s decline of 7%.
The FDA’s Breakthrough Therapy tag is granted to expedite development and review of drugs that target serious or life-threatening conditions and show substantial improvement over existing therapies on one or more significant clinical endpoints. Another potential benefit of the Breakthrough Therapy tag is the possibility to get priority review, which lowers the standard review period of a new drug application from 10 months to six.
The Breakthrough Therapy status was based on positive results from the phase II SimpliciT-1 study.
Data from the study showed that treatment with TTP399 led to a statistically significant improvement in HbA1c– a measure of blood sugar– relative to placebo, as well as a clinically meaningful decrease in the frequency of severe and symptomatic hypoglycemia.
Per the company, hypoglycemia is one of the major causes of morbidity and potential mortality in the treatment of type I diabetes. Hence, if successfully developed and upon potential approval, TTP399 can serve an area of high unmet medical need.
Notably, in March 2021, vTv Therapeutics initiated a mechanistic study to see the effects of TTP399 on ketone body formation during a period of insulin withdrawal in people with type I diabetes. Top-line data from the study is expected later in 2021.
The company remains focused on advancing the development of TTP399 with several pivotal studies expected to begin later this year.
Zacks Rank & Stocks to Consider
vTv Therapeutics currently carries a Zacks Rank #2 (Buy). Other stocks worth considering in the biotech sector include ASLAN Pharmaceuticals Limited ASLN, Repligen Corporation RGEN and Nabriva Therapeutics AG NBRV, all carrying the same Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
ASLAN Pharmaceuticals’ loss per share estimates have narrowed 33.3% for 2021 and 26.8% for 2022 over the past 60 days. The stock has surged 66.6% year to date.
Repligen’s earnings estimates have been revised 15.1% upward for 2021 and 9.8% upward for 2022 over the past 60 days. The stock has increased 11% year to date.
Nabriva Therapeutics’ loss per share estimates have narrowed 45.8% for 2021 and 50.9% for 2022 over the past 60 days.
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