Today’s new Top Pick for 2013 comes from The KonLin Letter Editor Konrad Kuhn, whose research into this Pink Sheets-listed pharmaceutical suggests it has the potential to more than quintuple in price.
“Fibromyalgia syndrome (FM) is a common and complex central nervous system condition characterized by chronic diffuse musculoskeletal pain, increased pain sensitivity at multiple tender points, fatigue, abnormal pain processing, disturbed sleep and often psychological stress.
“The National Pain Foundation estimates that 90% of FM patients (90% of whom are women) have sleep problems, and it has been estimated about 25% of people with FM are work disabled. Patients with FM hurt all over their bodies and can’t get restorative sleep. It’s a vicious cycle where no restorative sleep leads to pain and pain leads back to further difficulty sleeping.
“TONIX Pharmaceutical Holdings, Inc. (TNXP, $0.44) is a development-stage, patient-focused company developing innovative prescription medications for challenging disorders of the central nervous system (CNS). TNXP targets conditions characterized by significant unmet medical need, inadequate existing treatment options and high dissatisfaction among patients and physicians. TNXP’s core technology improves the quality of sleep in patients with chronic pain syndromes, believed to translate into reductions in daytime pain and other symptoms.
“TONIX’s lead product candidate, TNX-102 SL, is a novel, under-the-tongue, low-dose bedtime tablet formulated with cyclobenzaprine (CBP), the active ingredient in two FDA-approved muscle relaxants. An Investigational New Drug Application has been filed with the FDA for the Advanced TNX-102 SL bedtime treatment of FM. The drug is expected to enter the first of two Phase III trials for fibromyalgia in early Q1 2013 and the data should be analyzed before the end of 2013. The active ingredient CBP has a long 36-year safety record and is already the third-most widely prescribed off-label treatment for FM patients, but is currently neither designed nor approved for a bedtime treatment for FM.
“It’s believed TONIX is the leading company addressing sleep quality and improving restorative sleep in FM patients. The company recently completed a successful $3.4 million private placement to further the development of TNX-102 SL and for general working capital. Of the 43.2 million shares outstanding, 42.7% are held by insiders and 5.6% by institutions.
“In addition, TONIX is also exploring the utility of TNX-102 SL in a new bedtime treatment paradigm for post-traumatic stress disorder (PTSD), a potentially debilitating anxiety disorder triggered by exposure to a traumatic experience. TNXP expects to file a second Investigational New Drug Application for this indication in early 2013 and to initiate a Phase II trial of the drug candidate for PTSD. Sleep disturbances are common symptoms of PTSD and include difficulty falling or staying asleep. Several lines of evidence link sleep disturbances to chronically perpetuating PTSD.
“Meanwhile, the stock has been quietly trading in the $0.50-$0.60 area for a first target of $2.00-$2.50, especially if the innovative TNX-102 SL obtains FDA approval as a first-in-class drug for FM to replace off-label genetic muscle relaxers. The commercial product based on the new formulation would be protected from substitution by pharmacists with genetic CBP, a huge market opportunity. Ultimate target $4-$5.”
- Konrad Kuhn, The KonLin Letter, January 4, 2013