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TNXP

Tonix Pharmaceuticals

$2.33

-0.095 (-3.92%)

07:57
04/04/19
04/04
07:57
04/04/19
07:57

Tonix Pharmaceuticals expands TNX-102 SL to treat fibromyalgia

Tonix Pharmaceuticals announced the expansion of the TNX-102 SL 5.6 mg program beyond posttraumatic stress disorder, or PTSD, to include Phase 3 development for TNX-102 SL in fibromyalgia. TNX-102 SL, or Tonmya, is Tonix's lead Phase 3 program in PTSD with the Phase 3 RECOVERY trial actively enrolling military and civilian PTSD participants. In a recent clinical guidance meeting with the FDA, Tonix received clear guidance and support to advance the development of TNX-102 SL, a non-opioid centrally-acting analgesic, for the management of fibromyalgia. Acceptable study design features were discussed to establish the safety and efficacy of TNX-102 SL 5.6 mg in a pivotal study to support the fibromyalgia indication. A lower dose of TNX-102 SL taken daily at bedtime was studied previously in fibromyalgia in a Phase 2 study and a Phase 3 study. Both studies showed clinical benefits especially in the quality of sleep improvement, however, primary analyses on pain reduction were not statistically significant. Additional data developed by Tonix in the PTSD program showed that TNX-102 SL 5.6 mg demonstrated acceptable tolerability with additional clinical benefit in pain reduction for trial participants with PTSD. There were no serious and/or unexpected adverse events reported; the most common adverse events were mostly related to local administration site reactions, such as oral hypoaesthesia and abnormal product taste. Supported by the safety and efficacy findings in PTSD, Tonix believes that increasing the dose of TNX-102 SL from 2.8 mg to 5.6 mg in the new Phase 3 fibromyalgia study will likely provide the clinical evidence to support the 5.6 mg dose as the efficacious dose for the management of fibromyalgia. The registration of TNX-102 SL 5.6 mg for the fibromyalgia indication will be supported by two positive Phase 3 studies and the long-term safety exposure data from the PTSD program may support the fibromyalgia NDA.

  • 03

    May

TNXP Tonix Pharmaceuticals
$2.33

-0.095 (-3.92%)

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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