Tonix Pharmaceuticals announces engagement of Rho as CRO

Tonix Pharmaceuticals announced that it has engaged Rho, a global contract research organization, CRO, to support Tonix’s preparation and planned submission of its New Drug Application, NDA, to the U.S. Food and Drug Administration, FDA, for the approval of Tonmya for the management of fibromyalgia. “We are excited by our most recent positive Phase 3 study results of Tonmya and look forward to Rho’s support in preparing our NDA,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “We intend to meet with the FDA in the first half of this year and to submit our NDA in the second half of the year. We believe we have completed all development work required for the NDA, including CMC requirements and the completion of two positive Phase 3 studies.”