VTGN stock is still attracting buyers after the company announced on December 10, 2019, that it received fast-track designation from the FDA.
On December 10, 2019, VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet need, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for development of the Company’s PH94B neuroactive nasal spray for on-demand treatment of social anxiety disorder (SAD).
The FDA’s Fast Track process is designed to facilitate the development and review of new treatments for serious conditions with unmet medical need, such as SAD, with the purpose of getting innovative new treatment options to patients sooner. After successful Phase 2 development, VistaGen is preparing PH94B for Phase 3 development. PH94B has potential to be the first fast-acting, non-sedating, as-needed treatment for as many as 20 million individuals in the U.S. suffering from SAD.
“The FDA’s grant of Fast Track designation for development of PH94B for SAD, which to our knowledge is the FDA’s first Fast Track designation for a SAD drug candidate, is another important regulatory milestone for VistaGen and a key step forward in our development program for PH94B as a new generation anxiolytic. With a high global prevalence of anxiety disorders, including SAD, and alarming increases in dependency, addiction and even deaths associated with misuse of benzodiazepines, the urgency for a new non-addictive, non-sedating, fast-acting, as-needed treatment for SAD and other anxiety disorders is more important now than ever before. Based on clinical studies to date, PH94B, at non-systemic microgram doses, has strong potential to fill the large current treatment gap,” said Shawn Singh, Chief Executive Officer of VistaGen.
On November 14, 2019, William Blair analyst Tim Lugo downgraded VistaGen Therapeutics to Market Perform from Outperform after the company announced that the Phase 2 ELEVATE study of AV-101 for the adjunctive treatment of major depressive disorder, or MDD, failed to meet its primary endpoint. The failure of ELEVATE is a setback, but he still views PH94B and PH10 as “intriguing assets,” Lugo tells investors. Though he thinks both of those programs hold value, Lugo is concerned with the company’s cash position, with $4M on hand as of the last quarter, and its ability to execute on the opportunities he sees for PH94B and PH10, the analyst added.