NEW YORK, NY / ACCESSWIRE / November 1, 2018 / Shares of Tonix Pharmaceuticals were flying higher in Wednesday’s session on news that the company plans to start a new Phase 3 trial of Tonmya, a drug formulation in development for the treatment of post-traumatic stress disorder. Shares of ACADIA Pharmaceuticals was in the red despite announcing positive top-line results.
RDI Initiates Coverage on:
Tonix Pharmaceuticals Holding Corp.
ACADIA Pharmaceuticals Inc.
Tonix Pharmaceuticals Holding Corp. shares closed up 12.50% with an additional 4.17% in gains on Wednesday. The stock traded nearly 15.5 million shares in comparison to an average trading volume of roughly 1.1 million shares. The company announced that it plans to start a new Phase 3 trial of Tonmya®* for the treatment of post-traumatic stress disorder (PTSD) in the first quarter of 2019, based on guidance from its recent Breakthrough Therapy Type B Clinical Guidance meeting with the U.S. Food and Drug Administration (FDA). Seth Lederman, M.D., President and Chief Executive Officer of Tonix commented, “Results from our Phase 3 HONOR study strengthened the design of the new Phase 3 study, which has been accepted by the FDA as a potential pivotal efficacy study to support NDA approval. We believe the innovative design features of this new Phase 3 study will expedite the development of Tonmya for PTSD."
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ACADIA Pharmaceuticals Inc. shares closed down 7.63% on about 9.2 million shares traded on Wednesday. Yesterday the company announced positive top-line results from CLARITY, a randomized, double-blind, placebo-controlled, multi-center, sequential parallel comparison design (SPCD) study in major depressive disorder (MDD). Serge Stankovic, M.D., M.S.P.H., ACADIA's Executive Vice President Head of Research & Development stated, "We are pleased with the robustness of the data from our Phase 2 CLARITY trial, which shows significant promise for patients with MDD, including early and sustained antidepressant response over placebo, decreased daytime sleepiness, no meaningful weight gain, and improved sexual function. This is important because most people with MDD do not respond to initial antidepressant therapies and experience significant unwanted side effects." He added, "Pimavanserin is a selective serotonin inverse agonist, or SSIA, that shows great potential as an antidepressant. We look forward to engaging with the FDA and initiating a Phase 3 program in the first half of 2019.”
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