Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) saw its shares make a solid gain to start off the week after the company announced an update from the U.S. Food and Drug Administration (FDA) regarding its Alzheimer’s agitation treatment.
Specifically, the FDA granted Fast Track designation to Tonix’s investigational new drug, TNX-102 SL, for the treatment of agitation in Alzheimer’s disease. The same drug, TNX-102 SL, or Tonmya, for the treatment of post-traumatic stress disorder (PTSD), has previously been designated as a Breakthrough Therapy by the FDA. It is currently in a Phase 3 study for military-related PTSD, with an interim analysis expected in the third quarter of 2018.
Previously, Tonix had received clearance of the Investigational New Drug Application (IND) from the FDA for TNX-102 SL 5.6 mg in April, which supports the initiation of a Phase 2, potential pivotal efficacy study of TNX-102 SL in patients with agitation in Alzheimer’s disease.
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The benefits of a Fast Track designation include rolling submission of portions of the New Drug Application (NDA) for the drug candidate and eligibility for priority review of the NDA. Additionally, the company has the option for more frequent meetings and written communication with the FDA throughout the development and review process.
Seth Lederman, M.D., CEO of Tonix, commented:
Fast Track designation reflects the recognition by the FDA that TNX-102 SL has the potential to address a large unmet medical need for a serious condition. Currently, there are no FDA-approved treatments for agitation in Alzheimer’s disease, despite a high disease burden and a need for an effective therapy. We are eager to work closely with the FDA to advance the development TNX-102 SL for the treatment of agitation in Alzheimer’s disease.
Shares of Tonix were last seen up about 18% at $4.65, with a consensus analyst price target of $9.40 and a 52-week range of $2.70 to $5.11.
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