Research, Charts & Company Announcements
Research Tree provides access to ongoing research coverage, media content and regulatory news on TONIX PHARMACEUTICALS HOLDIN. We currently have 6 research reports from 1 professional analysts.
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Research reports on
TONIX PHARMACEUTICALS HOLDIN
TONIX PHARMACEUTICALS HOLDIN
Breakthrough Therapy Designation in PTSD
23 Jan 17
Tonix has announced that it has been granted Breakthrough Therapy Designation (BTD) by the FDA as its Phase II AtEase data for TNX-102 SL in military-related PTSD indicate the drug may successfully treat a serious condition, a key requirement for BTD. Key benefits of BTD are intensive guidance from the FDA on the drug development program, an organizational commitment involving senior managers at the FDA, and the submission of portions of the NDA on a rolling basis.
Phase II success in military-related PTSD
25 May 16
Tonix reported positive Phase II results for TNX-102 SL (sublingual formulation of cyclobenzaprine) marking the first-ever large multicenter trial for military-related PTSD. The 237-person study compared two dosage levels (2.8mg and 5.6mg) against placebo and found a significant improvement for the 5.6mg dose (p=0.038) in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), the primary endpoint for approval.
Fibromyalgia and PTSD data coming up
01 Apr 16
Tonix is developing TNX-102 SL, a sublingual formulation of cyclobenzaprine for two large indications, fibromyalgia and post-traumatic stress disorder (PTSD). The fibromyalgia program is the most advanced and we expect a read out of Phase III data in Q316. Due to previous data and clinical trial design improvements over its Phase IIb BESTFIT trial, we believe Phase III has a high chance of success. Data from a proof-ofconcept Phase II trial in PTSD is expected in Q216, although we view this as very high risk because it is an exceptionally difficult indication.
All systems go for 2016
07 Dec 15
With readouts from three clinical trials expected in 2016, next year will be a critical one for Tonix. First will be data from a Phase II study for TNX-201 (R-isomer of isometheptene) in Q116 for episodic tension-type headache (ETTH), which may offer an effective and non-addictive option. Next will be data from a Phase II trial for TNX-102 SL in H116 for post-traumatic stress disorder (PTSD), where current medications have spotty efficacy. Finally, the Phase III for Tonmya (TNX-102 SL) in fibromyalgia should read out in H216, which we suggest has a high chance of success.
Additional data support mechanism of action
24 Nov 15
Data from the Phase IIb BESTFIT trial reported at the American College of Rheumatology (ACR) conference support the idea that improvements in sleep quality are correlated with improvements in pain. As Tonmya (TNX-102 SL) benefits sleep quality, these data are reassuring and we continue to be confident in the success of the Phase III AFFIRM trial. Data from the AFFIRM trial are expected in Q316.
EULAR data update
23 Jun 15
At the European League Against Rheumatism (EULAR) meeting in Rome on 10-13 June, additional data from the Phase IIb BESTFIT trial with TNX-102 SL in fibromyalgia was presented. The product profile of an efficacious treatment with limited systemic side effects was confirmed. In May, Tonix announced they have launched the Phase III AFFIRM study with data expected in H216.
N+1 Singer - Morning Song 21-03-2017
21 Mar 17
accesso Technology (ACSO LN) Full year results in line, but key trading months still ahead | Augean (AUG LN) Double digit growth in ’16, good start to ‘17 | Earthport (EPO LN) Interims show continued top line strength | Goals Soccer Centres (GOAL LN) Good momentum under new team. It’s now all about delivery | IQE (IQE LN) FY’16 results prompt further upgrades | Microsaic Systems (MSYS LN) Challenges in 2016, strategy remains in place | mporium Group (MPM LN) Funds raised to help execute strategy | RhythmOne (RTHM LN) Dawn of the independents | ScS Group (SCS LN) Strong progress on key growth initiatives albeit comps now toughen | Sinclair Pharma (SPH LN) FY results: EBITDA ahead, Instalift™ gaining pace | Vectura Group (VEC LN) FY (9-month) results
16 Mar 17
4imprint (FOUR): 6% dividend yield for a growth stock? (BUY) | Cambridge Cognition* (COG): Amgen uses CANTAB technology in trial (CORP) | Seeing Machines* (SEE): H1 results show steady operational progress (CORP) | Allergy Therapeutics (AGY): Pollinex Quattro Birch Ph III EU trial starts (BUY) | Capital Drilling* (CAPD): FY results in line, with turnaround in exploration activity (CORP)
N+1 Singer - EKF Diagnostics - Final results & potential buy back
20 Mar 17
FY16 prelims are slightly ahead of our latest expectations, those having been increased materially over the course of H2’16 as the strength of the recovery in trading became apparent. In order to maximise shareholder value, the directors are currently examining a potential break up of the group. This would also involve a delisting from AIM. A buy back offer at 21.5p would therefore be made to those investors that wish to exit now rather than holding their shares for the two years plus it would likely take to achieve a potentially higher realisation value for the businesses.
N+1 Singer - N1S Trend spotting - Strategy update
08 Mar 17
In this new product we present some strategy theme updates arising out of our latest analysis of macro trends and economic data and our innovative Quant work. We also look at upcoming events and suggest topping up on some of our Best Ideas for 2017.
Good results, but further restructuring complex for investors
20 Mar 17
EKF Diagnostics FY 2016 results are slightly ahead of expectations, with both higher revenue and better EBITDA. Management has also announced plans to split the company into two separate companies, Point of Care and Laboratory Diagnostics, with the prospect of a delisting to manage the process. The primary metric for valuation of the two businesses is different consequently we believe that the separation is likely to generate significant value. However, in anticipation of the volatility likely given the restructuring announced this morning, despite the strength of the results, we reduce our recommendation to HOLD and maintain our 21p target price.
N+1 Singer - Morning Song 22-03-2017
22 Mar 17
Carador Income Fund (CIFU LN) Premium rating restored, high levels of refinancing activity | Cello Group (CLL LN) Outlook getting brighter – watch Pulsar | Eckoh (ECK LN) Largest ever US secure payments win | eg solutions (EGS LN) Full year results in line | Futura Medical (FUM LN) Licensing deal for CSD500 in Portugal | Verona Pharma (VRP LN) Global agreement with QuintilesIMS to support development of RPL554 | Xaar (XAR LN) 2016 results slightly ahead, reduced visibility in 2017