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Tonix Pharma Rips Higher After FDA OKs Study Design For PTSD Drug

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Tonix Pharma Rips Higher After FDA OKs Study Design For PTSD Drug
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Tonix Pharmaceuticals (NASDAQ: TNXP) shares — which began to trade on a split-adjusted basis Wednesday after a decision to enact a 1-for-10 reverse stock split — were seeing strong buying interest Thursday morning.

What Happened

The biopharma company announced Thursday ahead of the market open that the FDA has formally communicated through the minutes of an Oct. 29 Breakthrough Therapy Type B Clinical guidance meeting that it has accepted the study design of the new Phase 3 RECOVERY trial evaluating the company's TNX-102 SL as a bedtime treatment option for post-traumatic stress disorder, or PTSD.

The FDA has conditionally accepted the trade name Tonmya for the pipeline asset, according to Tonix

The minutes are in conformance with the initial guidance the company received at the meeting, it said.

The study will include several new features, including restricting enrollment of participants with PTSD who experienced an index trauma within nine years of screening, as opposed to a restriction of 2001 or later in the previous late-stage HONOR trial.

The primary endpoint is the same as in the previous Phase 3 and Phase 2 studies, although assessment will be done at week four instead of week 12.

Why It's Important

Tonmya, which is Tonix' lead candidate, hasn't yet been approved for any other indication. It's also being evaluated under a separate IND as a bedtime treatment for agitation in Alzheimer's disease.

What's Next

Tonix said it is moving forward expeditiously to initiate the RECOVERY STUDY in the first quarter of 2019, with the top-line data from the study expected in the first half of 2020. 

Tonix shares were ripping higher by more than 96 percent to $7.45 at the time of publication Thursday. 

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