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Tonix Pharmaceuticals skyrockets on additional details of a Phase 3 trial

Tonix Pharmaceuticals (Nasdaq: TNXP) stock skyrocketed during Thursday’s trading session after the pharma company announced additional details of its Phase 3 trial for the treatment of posttraumatic stress disorder (PTSD). The stock climbed to $9.60 in the Thursday’s morning session and pared the gains in the afternoon.

The New York-based Tonix announced a 1-for-10 reverse stock on Tuesday. The reverse stock split was previously approved by the Board of Directors of Tonix in accordance with Nevada law, under which no stockholder approval is required, and is intended to increase the per share trading price of Tonix’s common stock to satisfy $1.00 minimum bid price requirement for continued listing on The NASDAQ Global Market.

Commenting on the clinical news, CEO Seth Lederman said, “The minutes from our Breakthrough Therapy Clinical Guidance meeting with the FDA are consistent with our previous assessment. We are moving forward expeditiously to initiate the RECOVERY study in the first quarter of 2019 and expect to have topline data in the first half of 2020.”

Tonix is developing Tonmya, which is in Phase 3 development and has been granted Breakthrough Therapy designation, as a bedtime treatment for PTSD.  The company now has regulatory approval to move forward with the trial and bringing it one step closer to bringing Tonmya to market.

On October 31, the clinical-stage biopharma company stated that it will start a new Phase 3 trial of Tonmya for the treatment of PTSD. In July 2018, the company stopped its Phase 3 HONOR study of Tonmya due to inadequate separation from placebo on the primary endpoint at week 12.

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For the third quarter, the company didn’t report its revenue numbers. Net loss increased to $0.73 per share from $0.65 per share in the prior year quarter, due to higher R&D costs.

Shares of Tonix surged about 8% as of 3 PM ET. The stock has plunged 80% in this year so far, while it dropped 83% in the past one year.

 

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