Tonix Pharmaceuticals announces pre-IND meeting with FDA for TNX-102 SL

Tonix Pharmaceuticals (TNXP) announced the successful completion of a Type B Pre-Investigational New Drug meeting with the U.S. Food and Drug Administration, FDA, regarding the development of TNX-102 SL for the treatment of major depressive disorder, MDD. The Company received positive feedback from the FDA and plans to pursue a supplemental new drug application, sNDA, to expand the therapeutic indication of TNX-102 SL to include MDD, based on exploratory findings suggesting that improving sleep quality may positively impact depressive symptoms. “We are pleased with the outcome of our Pre-IND meeting with the FDA and appreciate their thoughtful guidance,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “This marks a significant step forward in our efforts to develop TNX-102 SL as a novel treatment for MDD, a condition that affects millions and remains underserved by current therapies that are often difficult to tolerate.”