Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2015 Financial Results and Provides Programs Update

Tonix Pharmaceuticals Holding Corp.(NASDAQ:TNXP) announced financial results for the fourth quarter and full year ended December 31, 2015.
According to the news:

Recent Clinical Highlights and Upcoming Milestones

Tonmya – Fibromyalgia Program

• Tonix is developing TNX-102 SL for daily use at bedtime for the management of fibromyalgia, a chronic condition.
• In May 2015, Tonix commenced the randomized, double-blind, placebo-controlled, 12-week Phase 3 AFFIRM clinical trial of Tonmya in fibromyalgia.
• Tonix expects to report top-line data from the AFFIRM trial in the third quarter of 2016.
• The primary efficacy endpoint in AFFIRM is a 30% pain responder analysis at week 12.
• Tonix expects to commence a second, 12-week Phase 3 trial of Tonmya in fibromyalgia in the second quarter of 2016.
• Results from the completed Phase 2b BESTFIT clinical trial of Tonmya in fibromyalgia was the subject of three posters presented at the American College of Rheumatology Annual Meeting on November 10, 2015.

Seth Lederman, M.D., president and chief executive officer of Tonix commented:

Tonix made tremendous progress over the course of 2015 on the clinical, regulatory and operational fronts. We remain very focused on progressing our flagship clinical development program, a Phase 3 trial in fibromyalgia of Tonmya^® (TNX-102 SL, cyclobenzaprine HCl sublingual tablets, 2.8 mg) and our registration-quality Phase 2 study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in PTSD. We look forward to the year ahead as we will announce top-line data from our Phase 2 AtEase clinical trial of TNX-102 SL in PTSD in the second quarter, followed by top-line data from our Phase 3 AFFIRM study in fibromyalgia in the third quarter of this year.

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