07:44 AM EST, 11/24/2025 (MT Newswires) -- Tonix Pharmaceuticals ( TNXP ) said Monday the US Food and Drug Administration has cleared its investigational new drug application for TNX-102 SL for the treatment of major depressive disorder, or MDD, in adults.

The company said the IND clearance will allow it to proceed with the phase 2 Horizon study, a six-week, randomized trial of the drug candidate as a first-line monotherapy for MDD.

The trial will enroll about 360 patients across 30 US sites.

Tonix said eligible participants are 18 years or older and currently experiencing a moderate to severe major depressive episode. It added that it plans to start enrollment in the middle of next year.

Shares of the company fell more than 2% in recent premarket activity Monday.