We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
vTv Therapeutics (VTVT) Gets Breakthrough Tag for Diabetes Drug
Read MoreHide Full Article
vTv Therapeutics Inc. (VTVT - Free Report) 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.
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.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
Image: Bigstock
vTv Therapeutics (VTVT) Gets Breakthrough Tag for Diabetes Drug
vTv Therapeutics Inc. (VTVT - Free Report) 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 - Free Report) , Repligen Corporation (RGEN - Free Report) and Nabriva Therapeutics AG , 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.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
See these 7 breakthrough stocks now>>