Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) said Monday that its fourth-quarter milestones included the initiation of its new Phase 3 trial for a treatment of post-traumatic stress disorder.
The clinical-stage biopharmaceutical company said enrollment began in March for the study of Tonmya for the treatment of post-traumatic stress disorder. In November, the Food and Drug Administration accepted the design of the study, which includes civilian- as well as military-related trauma.
“Looking forward into 2019, we are excited about the recent initiation of our new Phase 3 study of Tonmya for PTSD," Dr. Seth Lederman, president and CEO, said in a statement.
The new study incorporates learnings and analyses from its Phase 2 and Phase 3 studies in more than 500 military-related post-traumatic stress disorder participants and is intended to support the registration of Tonmya, according to Lederman.
Other highlights for the company included completing a clinical-guidance meeting with the FDA in March to discuss the fibromyalgia registration plan for the drug TNX-102 SL and a new Phase 3 study.
For the quarter, the New York-based company said its research and development expenses rose to $5.1 million from $3.6 million a year earlier.
The net loss available to common stockholders was $10.9 million, or $6.10 per share, for the fourth quarter, compared with a net loss of $5.5 million, or $7.07 per share, a year earlier.
Shares of Tonix slipped $0.01 to $2.87 in Monday’s Nasdaq trading.
Contact Dennis Fitzgerald at [email protected]