Tonix Pharmaceuticals reports Q4 EPS ($9.77) vs. ($2,179.83) last year

Reports Q4 revenue $2.6M, consensus $3.35M.”With commercial preparations underway, we believe we are well positioned to launch TNX-102 SL for the management of fibromyalgia in the fourth quarter of this year if approved by the U.S. Food and Drug Administration,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “We believe that TNX-102 SL has the potential to be the first in a new class of non-opioid analgesic medicines for the management of fibromyalgia, and the first new drug for treating fibromyalgia in more than 15 years.” Fibromyalgia is a debilitating chronic pain condition affecting over 10 million adults in the United States, most of whom are women. Data from our pivotal Phase 3 trials indicate that TNX-102 SL can provide fibromyalgia patients with significant reduction in pain. TNX-102 SL was generally well tolerated and has no known addictive properties. Dr. Lederman continued, “Tonix is debt free and expects to have sufficient cash to fund operations through the PDUFA target date of August 15, 2025, and the anticipated commercial launch of TNX-102 SL in the fourth quarter of this year. We continue to meaningfully add to our commercial team and are engaged in pre-launch activities. We look forward to continuing discussions with the FDA throughout the review period in advance of the PDUFA goal date to bring patients a potential new treatment option.”