What's Driving The Rally In Nanocap Biotech Tonix Pharma?

Tonix Pharmaceuticals Holding Corp TNXP shares are gaining momentum following a Thursday morning announcement from the company. 

What Happened

Tonix, a biopharma company developing treatments for serious neuropsychiatric and central nervous system conditions, said it plans to expand its TNX-102 SL 5.6 mg program beyond post-traumatic stress disorder.

TNX-102 SL, or Tonmya, a non-opioid, centrally acting analgesic, is the company's lead late-stage asset being evaluated for PTSD in a Phase 3 trial.

The trial, dubbed RECOVERY, is actively enrolling military and civilian PTSD participants.

Following a recent Clinical Guidance meeting with the FDA, Tonix said it has received guidance from the regulatory body to advance the development of Tonmya for the management of fibromyalgia.

Tonix had earlier tested a lower-dose Tonmya in Phase 2 and Phase 3 studies for fibromyalgia. Although the lower dose brought about an improvement in the quality of sleep, primary analyses on pain reduction were not statistically significant, the company said.

Based on the safety and efficacy findings in PTSD, the company said increasing the dose of TNX-102 SL from 2.8mg to 5.6mg in the new Phase 3 fibromyalgia study will likely provide clinical evidence to support 5.6mg as the efficacious dose for the management of fibromyalgia.

"The registration of TNX-102 SL 5.6 mg for the fibromyalgia indication will be supported by two positive Phase 3 studies, and the long-term safety exposure data from the PTSD program may support the fibromyalgia NDA," Tonix said.

Why It's Important

Fibromyalgia is a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues. The condition is said to affect 5-15 million Americans.

The need for new fibromyalgia drugs is pressing, given the fact that one-third of the patients are on opiates, Tonix said. 

Price Action

Tonix shares were jumping 21.89 percent to $2.84 on higher-than-average volume at the time of publication. 

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