VistaGen Therapeutics, Inc. (VTGN - Free Report) announced that the FDA has granted a Fast Track designation to its first-in-class neuroactive nasal spray PH94B for on-demand treatment of social anxiety disorder (SAD), also called social phobia. Following successful completion of the phase II study on PH94B, VistaGen is now planning for its phase III development.
The FDA provides a Fast Track designation to help the development and faster review of drugs, which treat serious and unmet medical conditions. Per the company, PH94B becomes the first drug candidate to be granted a Fast Track status by the regulatory agency for treating SAD.
Shares of VistaGen were up an impressive 44.6% following the announcement of the aforementioned news on Tuesday. However, the stock has plunged 58.7% so far this year against the industry’s increase of 6.1%.
VistaGen, a clinical-stage biopharmaceutical company, is developing differentiated new generation medications for central nervous system (CNS) diseases and disorders with high unmet need.
Apart from PH94B, the company’s clinical-stage pipeline candidates include AV-101 and PH10.
AV-101 is an NMDA (N-methyl-D-aspartate) receptor glycine site antagonist, which is being evaluated as an adjunctive treatment of major depressive disorder (MDD).
In November 2019, VistaGen announced disappointing results from the phase II ELEVATE study, which evaluated the safety, tolerability and efficacy of AV-101 as an adjunctive treatment in patients with MDD, who had an inadequate response to a stable dose of standard antidepressant therapy.
AV-101 is also being developed as a non-opioid treatment for chronic neuropathic pain and an oral therapy for dyskinesia associated with levodopa therapy for Parkinson’s disease and suicidal ideation.
Notably, PH10 is a novel, rapid-acting CNS neuroactive nasal spray, currently being developed for treating MDD.
Zacks Rank & Other Stocks to Consider
VistaGen currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the biotech sector include Anika Therapeutics Inc. (ANIK - Free Report) , Guardant Health, Inc. (GH - Free Report) and Innoviva, Inc. (INVA - Free Report) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates have moved 16% north for 2019 and 17.4% for 2020 over the past 60 days. The stock has soared 64.9% year to date.
Guardant Health’s loss per share estimates have narrowed 30.7% for 2019 and 8.5% for 2020 over the past 60 days. The stock has skyrocketed 95.1% so far this year.
Innoviva’s earnings estimates have been revised 18.7% upward for 2019 and 25.2% for 2020 over the past 60 days.
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