Tonix Pharmaceuticals Holding Corp. (TNXP) Falls 35% on Disappointing Phase 2 Results


Tension headaches can be quite the headache in a person’s everyday life. This is one reason why Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) has been working on a drug they refer to as TNX-201. Investors have been hoping to see good clinical study results from the drug, aimed at treating episodic tension-type headaches. Today, however, Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) reported that TNX-201 missed it’s primary efficacy endpoint in a Phase 2 proof-of-concept study. This has caused the stock to fall 35.64% in pre-market trading this morning. It’s now trading at just $2.60 per share.

Other than not achieving the primary efficacy endpoint, TNX-201 also did not achieve two other endpoints as well. The company isn’t giving up on the drug however.

“We were interested in exploring the potential clinical benefit of TNX-201 as a new class of analgesic that might offer a non-addictive headache treatment option. Racemic isometheptene mucate previously had been used as a treatment for both tension-type headaches and migraine,” explained Seth Lederman, M.D., Tonix’s president and CEO. “Given the current treatment landscape, we determined tension-type headache to be the most probable and feasible path to commercialization for TNX-201. We executed a well-designed and efficient POC study to determine whether our hypothesis had merit. Among other things, the data showed that TNX-201 did not demonstrate efficacy in patients with ETTH whether or not they had a history of migraine headaches. Although TNX-201 has proved to be safe and very well tolerated in the study, our review of the results supports discontinuing all work on this program.”

The stock closed at $4.04 during the last trading session. It is down 50.85% since July 10, 2015 and is downtrending. It has underperformed the S&P500 by 41.38%.

Tonix Pharmaceuticals Holding Corp., a clinical-stage pharmaceutical company, focuses on the identification and development of pharmaceutical products for the disorders of central nervous system in the United States. The company develops TNX-102 SL, a sublingual tablet formulation, which is in Phase 3 clinical development stage for the treatment of fibromyalgia; and Phase 2 clinical development stage for the treatment of post-traumatic stress disorder. It is also involved in the development of TNX-201, an oral formulation of (R)-isometheptene mucate for the treatment of episodic tension-type headache, which is in Phase 2 clinical development stage. In addition, the company has a pipeline of various other product candidates, including TNX-301, a fixed dose combination drug product for the treatment of alcohol abuse and dependence. Tonix Pharmaceuticals Holding Corp. was founded in 2007 and is headquartered in New York, New York.