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TNXP

Tonix Pharmaceuticals

$2.29

-0.035 (-1.51%)

13:54
04/23/19
04/23
13:54
04/23/19
13:54

Tonix Pharmaceuticals says USAMMDA exercising right to terminate CRADA

Tonix Pharmaceuticals announced that on April 18 the company received a notice of termination, effective April 29, whereby the U.S. Army Medical Materiel Development Activity, or USAMMDA, is exercising its contractual right to terminate without cause the Collaborative Research and Development Agreement, or CRADA, entered into on December 4, 2015 between the company and USAMMDA relating to the development of Tonmya or TNX-102 SL for the treatment of Posttraumatic Stress Disorder. "The termination does not affect Tonix's finances or the conduct of the ongoing RECOVERY trial in PTSD. Due to the statutory limitations on all CRADAs, Tonix's agreement with USAMMDA never contemplated nor contained any provision for funding Tonix or any PTSD study. There is, therefore, no financial impact to Tonix as a result of this action. A key objective of the CRADA was for USAMMDA to assist Tonix in recruiting active duty personnel from military treatment facilities into the Phase 2 AtEase and Phase 3 HONOR studies of military-related PTSD. However, no patients were recruited by USAMMDA from MTFs into either study. The ongoing RECOVERY trial is recruiting only patients whose PTSD results from trauma that occurred less than nine years before screening. Since the large U.S. troop deployments into the war zones in Iraq and Afghanistan were more than nine years ago, the number of relevant potential trial participants in MTFs would be lower than during our previous clinical trials. Therefore, we believe there is no patient recruitment impact to Tonix as a result of this action. Although a potential benefit of the CRADA was cooperation in planning PTSD studies, USAMMDA was not involved in the planning or execution of any Tonix PTSD study. Therefore, we believe there is no research or development impact to Tonix as a result of this action," the company said.

  • 03

    May

TNXP Tonix Pharmaceuticals
$2.29

-0.035 (-1.51%)

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.
04/18/19
ROTH
04/18/19
UPGRADE
ROTH
Buy
Tonix Pharmaceuticals upgraded to Buy from Neutral at Roth Capital
04/18/19
04/18/19
UPGRADE
Target $4

Buy
Tonix Pharmaceuticals upgraded to Buy at Roth Capital
As previously reported, Roth Capital analyst Scott Henry upgraded Tonix Pharmaceuticals to Buy from Neutral given that the company is attempting its third shot at the PTSD indication with the RECOVERY trial, enrollment adjustments give the trial a "reasonable shot at success," the cash runway could get the company to the key PTSD data readout in the first half of 2020, and the stock looks interesting using only a about 20% chance at approval. The analyst also raised his price target on the shares to $4 from 75c.

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