Tonix Pharmaceuticals reports Q3 EPS (23c), consensus ($2.93)

Reports Q3 revenue $2.822M, consensus $3.08M. “With our recent NDA submission to the U.S. Food and Drug Administration (FDA), Tonix is excited about the potential of TNX-102 SL to become the first new drug treatment option in more than 15 years for the roughly 10 million adults in the U.S. suffering from fibromyalgia,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “FDA awarded TNX-102 SL Fast Track designation in the third quarter of 2024, which is intended to expedite FDA review of important new drugs to fill unmet needs for serious conditions. We look forward to next steps with FDA. If the NDA filing is accepted in December, we expect a decision on the marketing approval of TNX-102 SL for fibromyalgia in 2025.”