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.
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. (CLBS - Free Report) and Ligand Pharmaceuticals (LGND - Free Report) . 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.
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