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.
VistaGen Up on Fast Track Designation to Pain Candidate
Read MoreHide Full Article
VistaGen Therapeutics, Inc. (VTGN - Free Report) announced that the FDA has granted Fast Track designation to its non-opioid pain candidate, AV-101. The company completed a phase I study evaluating the non-sedating candidate as an adjunct treatment for neuropathic pain.
The candidate also enjoys Fast Track designation for the treatment of major depressive disorder (“MDD”), which was granted in December 2017. Non-opioid pain medication is in focus as the FDA is committed to address adverse issues related to opioid treatment.
The FDA grants fast track designation to help the development and a faster review of drugs, which treat serious and unmet medical conditions. With this designation, the drug is expected to be granted priority review once it files a new drug application (“NDA”).
VistaGen’s shares were up almost 37.5% on Wednesday as investors cheered the FDA’s decision. Shares of the company have gained 87.8% so far this year against the industry’s decline of 3.1%.
VistaGen is a clinical stage biopharmaceutical company focused on developing new treatments for central nervous system (“CNS”) diseases and disorders with high unmet need.
The company is currently evaluating AV-101 in a phase II study – ELEVATE – as a treatment for MDD in patients who have inadequate response when treated with a standard antidepressant therapy.
Per the press release, neuropathic pain, which is characterized by steady burning or a pricking sensation resulting in abnormal neuronal function, is estimated to affect 33 million in the United States.
We remind investors that Alkermes (ALKS - Free Report) is also developing a candidate, ALKS 5461, for treating MDD. The candidate is under review in the United States with a decision expected in January 2019.
VistaGen currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks from the pharma space are Caladrius Biosciences, Inc. and Ligand Pharmaceuticals . Both the stocks carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Caladrius’ loss per share estimates have narrowed from $2.30 to $2.17 for 2018 and from $2.43 to $2.39 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 41.5%. The stock has rallied 64.4% so far this year.
Ligand’s earnings per share estimates have moved up from $5.64 to $6.33 for 2018 and from $5.59 to $5.74 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 89.3%. The stock has rallied 85.3% so far this year.
5 Companies Verge on Apple-Like Run
Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2018 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs. A bonus Zacks Special Report names this breakthrough and the 5 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains.
Image: Bigstock
VistaGen Up on Fast Track Designation to Pain Candidate
VistaGen Therapeutics, Inc. (VTGN - Free Report) announced that the FDA has granted Fast Track designation to its non-opioid pain candidate, AV-101. The company completed a phase I study evaluating the non-sedating candidate as an adjunct treatment for neuropathic pain.
The candidate also enjoys Fast Track designation for the treatment of major depressive disorder (“MDD”), which was granted in December 2017. Non-opioid pain medication is in focus as the FDA is committed to address adverse issues related to opioid treatment.
The FDA grants fast track designation to help the development and a faster review of drugs, which treat serious and unmet medical conditions. With this designation, the drug is expected to be granted priority review once it files a new drug application (“NDA”).
VistaGen’s shares were up almost 37.5% on Wednesday as investors cheered the FDA’s decision. Shares of the company have gained 87.8% so far this year against the industry’s decline of 3.1%.
VistaGen is a clinical stage biopharmaceutical company focused on developing new treatments for central nervous system (“CNS”) diseases and disorders with high unmet need.
The company is currently evaluating AV-101 in a phase II study – ELEVATE – as a treatment for MDD in patients who have inadequate response when treated with a standard antidepressant therapy.
Per the press release, neuropathic pain, which is characterized by steady burning or a pricking sensation resulting in abnormal neuronal function, is estimated to affect 33 million in the United States.
We remind investors that Alkermes (ALKS - Free Report) is also developing a candidate, ALKS 5461, for treating MDD. The candidate is under review in the United States with a decision expected in January 2019.
VistaGen Therapeutics, Inc. Price
VistaGen Therapeutics, Inc. Price | VistaGen Therapeutics, Inc. Quote
Zacks Rank & Key Picks
VistaGen currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks from the pharma space are Caladrius Biosciences, Inc. and Ligand Pharmaceuticals . Both the stocks carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Caladrius’ loss per share estimates have narrowed from $2.30 to $2.17 for 2018 and from $2.43 to $2.39 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 41.5%. The stock has rallied 64.4% so far this year.
Ligand’s earnings per share estimates have moved up from $5.64 to $6.33 for 2018 and from $5.59 to $5.74 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 89.3%. The stock has rallied 85.3% so far this year.
5 Companies Verge on Apple-Like Run
Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2018 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs. A bonus Zacks Special Report names this breakthrough and the 5 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains.
Click to see them right now >>