What happened
Tonix Pharmaceuticals (TNXP 0.90%), a rather up-and-down meme stock in the biotech sector, was having a fine day on the market Tuesday. And this wasn't because of some online hype from a meme stock investor; instead the company reported some encouraging news about a key pipeline drug.
So what
Tuesday morning, Tonix was all too happy to announce that the Food and Drug Administration (FDA) has cleared the Investigational New Drug application for its TNX-1900. That nod paves the way for Tonix to begin a phase 2 study of the drug for the prevention of migraines in chronic patients.
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The treatment of migraines has been a thorny challenge for biotechs and pharmaceutical companies for many years. According to Tonix, roughly 4 million people in the U.S. suffer from chronic migraines, presenting a robust patient base for the company should TNX-1900 eventually be authorized or approved by the regulator.
In the press release trumpeting the FDA's move, Tonix quoted its CEO Seth Lederman as saying of its pipeline drug, "We believe that by engaging and stimulating oxytocin receptors in the trigeminal ganglia, TNX-1900 has the potential to help chronic migraine sufferers."
Oxytocin, a hormone, is perhaps best known for its role in controlling and regulating important aspects of the human reproductive system.
Now what
Tonix said that it anticipates beginning enrollment in the phase 2 study in the second half of next year. The company has ambitions beyond migraine treatment for the drug; it added that it also plans to develop it for craniofacial pain and insulin resistance.
