Nov. 27, 2015, 10:43 AM
- The FDA's Psychopharmacologic Drugs Advisory Committee will meet on Tuesday, December 1, to review privately held Fabre-Kramer Pharmaceuticals' New Drug Application (NDA) for gepirone hydrochloride extended-release tablets for the treatment of major depressive disorder (MDD).
- FDA briefing doc
- Company briefing doc
- Draft questions
- MDD-related tickers: (OTCQB:VSTA)(OTCPK:OTSKY)(OTCPK:TKPYY)(NYSE:PFE)(NASDAQ:ALKS)(NASDAQ:AVNR)(NYSE:TEVA)(NASDAQ:SHPG)(NYSE:LLY)(NYSE:GSK)
Nov. 3, 2015, 10:41 AM
- VistaGen Therapeutics (OTCQB:VSTA) commences a Phase 2A clinical trial assessing lead product candidate AV-101 in adult patients with treatment-resistant Major Depressive Disorder (MDD). The NIH-funded study, being conducted at the U.S. National Institutes of Mental Health, will enroll 24-28 subjects.
- The randomized, placebo-controlled, crossover trial will evaluate the safety and efficacy of a single oral dose of AV-101 once daily for 14 days. Top-line results are expected in H1 2017.
- AV-101 is an orally available prodrug that is converted in the brain by cells called astrocytes into its active metabolite, 7-chlorokynurenic acid (7-CI-KYNA), a highly selective antagonist of the glycine-binding co-agonist (GlyB) site of the N-methyl-D-aspartate receptor (NMDAR). Evidence suggests that AV-101's antagonism of MNDAR signaling may provide fast-acting antidepressant effects in patients with chronic MDD.
Jun. 19, 2015, 8:14 AM
- VistaGen Therapeutics (OTCQB:VSTA) initiated with Buy rating and $50 (257% upside) price target by Chardan Capital Markets.
- Axovant Sciences (NYSE:AXON) initiated with Sell rating and $10 (48% downside risk) price target by Chardan Capital Markets.
- Omnicell (NASDAQ:OMCL) initiated with Outperform rating and $44 (14% upside) price target by Oppenheimer.
- Juno Therapeutics (NASDAQ:JUNO) initiated with Buy rating and $78 (50% upside) price target by Maxim Group.
- Molina Healthcare (NYSE:MOH) initiated with Buy rating and $80 (18% upside) price target by UBS.
- Pfizer (NYSE:PFE) initiated with Overweight rating and $45 (32% upside) price target by Jefferies.
- Supernus Pharmaceuticals (NASDAQ:SUPN) upgraded to Buy from Hold with an $18 (6% upside) price target by Jefferies.
- Lumenis (NASDAQ:LMNS) downgraded to Market Perform from Outperform by Wells Fargo. Not surprising since XIO Group will acquire at $14 per share.
Aug. 19, 2014, 11:43 AM
- The Canadian Intellectual Property Office issues a Notice of Allowance to VistaGen Therapeutics (OTCQB:VSTA) for its patent application No. 2,487,058 entitled "Mesoderm and Definitive Endoderm Cell Populations." The company has an exclusive license to the patent from the Icahn School of Medicine at Mount Sinai in New York.
- The patent extends VistaGen's IP portfolio for pluripotent stem cell culture systems.
VistaGen Therapeutics, Inc. is a biotechnology company which focuses on drug discovery, drug rescue and regenerative medicine. It develops medicine for cancer and diseases and conditions involving the central nervous system. The company was founded by H. Ralph Snodgrass and Gordon Keller on May... More
Industry: Drug Manufacturers - Other
Country: United States