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TNXP

Tonix Pharmaceuticals

$0.65

-0.0138 (-2.08%)

07:10
11/06/18
11/06
07:10
11/06/18
07:10

Tonix study analysis shows 'meaningful' response to Tonmya in PTSD participants

Tonix Pharmaceuticals presented a poster at CNS Summit 2018 held November 1-4, 2018, in Boca Raton, Fla. A poster, entitled "Time Since Trauma in PTSD: Phase 3 Multi-Center, Double-Blind, Placebo-Controlled Trial of TNX-102 SL, a Sublingual Formulation of Cyclobenzaprine, in Military-Related PTSD" includes results and retrospective analyses from the Phase 3 P301 study. TNX-102 SL, or Tonmya, is being developed for the treatment of posttraumatic stress disorder (PTSD). The poster can be found on the Scientific Presentations page of Tonix's website. The poster presentation reports that a retrospective analysis revealed a treatment effect in participants who experienced trauma less than or equal to nine years prior to screening. For this subgroup, the p-value of the primary endpoint at Week 12, using mixed model repeated measures with multiple imputation, was 0.039. In contrast, there was no benefit relative to placebo in the participants who experienced trauma more than nine years prior to screening. A retrospective analysis of female participants overall, and of military participants with non-combat index traumas experienced less than or equal to nine years from screening, suggests clinically meaningful separation from placebo at Weeks 4 and 12 in these specific subgroups. The female subgroup experienced an 11.5 point improvement in CAPS-5 at Week 4 and 9.1 point improvement at Week 12, while the non-combat participant subgroup experienced a 4.8 point improvement at Week 4 and 4.4 point improvement at Week 12. In addition, the Week 4 assessment of CAPS-5 in the Phase 3 HONOR study showed clinically meaningful improvement at this time point in the entire modified intent-to-treat population. Furthermore, for study participants who experienced trauma less than or equal to nine years prior to screening, all five secondary measures showed a p-value of less than0.05 at the Week 12 endpoint, indicating possible global and functional recovery, and improved sleep quality and mood after 12 weeks of Tonmya treatment compared with placebo. Based on these findings and following a recent Breakthrough Therapy Type B Clinical Guidance meeting with the U.S. FDA, the company plans to incorporate several new design features into the new Phase 3 study, including restricting enrollment of study participants to individuals with PTSD who experienced an index trauma within nine years of screening; enrolling participants who have experienced civilian traumas, in addition to those with military-related traumas; and a CAPS-5 primary endpoint assessed at Week 4 instead of at Week 12.

TNXP Tonix Pharmaceuticals
$0.65

-0.0138 (-2.08%)

06/06/18
RILY
06/06/18
INITIATION
Target $8
RILY
Buy
Tonix Pharmaceuticals initiated with a Buy at B. Riley FBR
B. Riley FBR analyst David Buck started Tonix Pharmaceuticals with a Buy rating and $8 price target. The analyst sees an attractive risk/reward ahead of a potential near-term catalyst for the company's treatment of post-traumatic stress disorder.
07/27/18
ROTH
07/27/18
DOWNGRADE
ROTH
Neutral
Tonix Pharmaceuticals downgraded to Neutral from Buy at Roth Capital
07/27/18
ROTH
07/27/18
DOWNGRADE
Target $1
ROTH
Neutral
Tonix Pharmaceuticals downgraded to Neutral from Buy at Roth Capital
Roth Capital analyst Scott Henry downgraded Tonix Pharmaceuticals to Neutral from Buy and lowered his price target to $1 from $6 following "disappointing" results from its interim Phase 3 analysis of Tonmya for the treatment of posttraumatic stress disorder. In a research note to investors, Henry notes that the trial was halted as the primary endpoint did not have adequate separation from placebo on the primary endpoint at week 12. While Henry notes that the data at week 4 of the trial did show separation from placebo for CAPS-5 and Clinical Global Impression - Improvement, he contends that PTSD is a "challenging" therapeutic category, and that although the FDA could allow for a shorter duration endpoint, "we view that as the exception as opposed to the rule." Henry does not expect a rebound in shares pending clarity from the FDA on the future pathway utilizing a shorter endpoint, and says shares are "no longer investable for most" due to an uncertain clinical risk profile and financial risk.
07/27/18
RILY
07/27/18
DOWNGRADE
Target $1.25
RILY
Neutral
Tonix Pharmaceuticals downgraded to Neutral from Buy at B. Riley FBR
B. Riley FBR analyst Tonix Pharmaceuticals to Neutral and cut his price target for the shares to $1.25 from $8. The downgrade follows Tonix's decision to stop the Phase III Honor study of Tonmya in military-related post-traumatic stress disorder. The stock in morning trading is down 65%, or $2.57, to $1.38.

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