Tonix Pharmaceuticals shares surge 14.05% after-hours following FDA clearance for Phase 2 trial of TNX-102 SL in major depressive disorder.

Tonix Pharmaceuticals Holding Corp. surged 14.05% in after-hours trading following the U.S. Food and Drug Administration’s clearance of its Investigational New Drug application for TNX-102 SL, enabling the initiation of a pivotal Phase 2 trial for major depressive disorder. The FDA approval allows Tonix to launch the HORIZON study, a randomized, placebo-controlled trial evaluating the drug’s efficacy as a first-line monotherapy for MDD. This milestone marks a critical advancement in the drug’s development, addressing a significant unmet need in mental health treatment. The clearance directly aligns with the stock’s upward movement, reflecting investor optimism about the trial’s potential to progress toward commercialization. Other news, including prior FDA approvals for Tonmya and analyst ratings, occurred earlier in the year and are less likely to have driven the recent after-hours surge.