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Tonix Pharmaceuticals Holding Forum: Community User: StefanN19
Kommentare 12.233
Matu,
28.10.2020 13:59 Uhr
0
Ist von heute, hier die Übersetzung:
Matu,
28.10.2020 13:57 Uhr
0
Tonix Pharmaceuticals provides updates for fibromyalgia and COVID-19 studies
Tonix Pharmaceuticals Holding Corp. (TNXP) announced the enrolment of first participant for its PRECISION study. The trial is being conducted to facilitate development of Precision Medicine Techniques for developing COVID-19 vaccines and therapeutics. The company also provided updates regarding the completion of its Phase 3 RELIEF study for TNC-102 SL for treating fibromyalgia.
PRECISION study is an observation trial for evaluating the immune response in healthy patients who have either recovered from COVID-19 or were asymptomatic. Seth Lederman of Tonix said, “This work may also guide the selection of appropriate participants for clinical trials of COVID-19 vaccines, including future human trials using Tonix’s TNX-1800, a live replicating, attenuated COVID-19 vaccine candidate designed to confer durable T cell immunity.” TNX-1800 is a live modified horsepox virus vaccine and works by expressing the Spike protein of the SARS-CoV-2 virus.
Tonix Pharmaceuticals also recently concluded its fibromyalgia study of TNX-102 SL. The unblinded interim analysis was conducted by an independent statistical team. The analysis was carried out on the first 50 percent of randomized participants who entered the 14-week study. On the basis of interim results, the independent data monitoring committee recommended the trial to be continued and to be further augmented by 210 participants on top of the original 470 patients. The company now plans to conclude the study by analyzing 503 currently enrolled participants.
Tonic expects the top line data to be out in the fourth quarter of this year. The company will stay blinded to the interim analysis results. Seth Lederman, CEO of Tonix, said, “Based on the prior Phase 2 and Phase 3 studies in fibromyalgia at a lower dose, we believe that TNX-102 SL has potential as a novel non-opioid, centrally-acting analgesic for the millions of U.S. adults suffering with fibromyalgia.” The company is currently recruiting for a new potentially pivotal Phase 3 trial for studying TNX-102 SL for managing fibromyalgia. The top line data from the study will likely be out during the second half of 2021.
The RELIEF and RALLY studies are double-blind, randomized, placebo-controlled trials. Each one targeted 470 patients, and the participants were administered TNX-102 SL 2.8 mg (1 tablet) or placebo in the run-in period during the first two weeks of treatment. The primary endpoint of the study was related to the change in daily diary pain severity score from baseline. The data was analyzed using mixed model repeated measures with multiple imputation.
Analysis: Tonix is another player on the COVID-19 landscape, repurposing a horsepox vaccine. The other Tonix candidate in the news targets fibromyalgia, which had a market of ~$2.8 billion in 2018, estimated to grow Y-o-Y at a CAGR of 3.3%. The 16-employee company lost over 80% of its market capitalization in the TTM to be at ~$87 million, currently trading at $0.64, near its 52-week low, from a high of $4.10 a year back. One Wall Street analyst is very bullish with a price target of $3. Over 96% shares are held by the public, while insiders hold only 0.11% shares. Institutions hold ~3.5% shares. The company has a cash balance of ~$55 million, about half a million debt, and a cash burn of about $38 million in the TTM.
Investment Thesis: With highly diverse product candidates, ranging from fibromyalgia to COVID-19, the company has strong catalysts ahead. However, the stock has not been able to come close to its highs and has a high risk profile.
Sky91,
27.10.2020 17:20 Uhr
0
Markus, soviel Langeweile in deinem Leben?
G
Gast-747484401,
27.10.2020 17:13 Uhr
0
Top. Dann viel Erfolg euch
Matu,
26.10.2020 20:55 Uhr
0
Genau Bios eben....wie heisst es so schön Geduld ist eine Tugend
S
Steff1,
26.10.2020 20:44 Uhr
0
Und nicht auf schlaue Kommentare hören
VesileVesila,
26.10.2020 20:42 Uhr
0
Und dieser Zusatz solte sie für viele Anleger interessanter machen... aber bei BIOS muss man viel Geduld ... Nerven mitbringen....
Matu,
26.10.2020 20:18 Uhr
0
Und Covid ist hier doch nur ein Zusatz
Matu,
26.10.2020 20:18 Uhr
0
Ich denke eher da spielen langsam die US Wahlen mit rein....
VesileVesila,
26.10.2020 20:00 Uhr
0
Ich habe gerechnet das die covid Aktien steigen... aber nicht mal die
VesileVesila,
26.10.2020 19:58 Uhr
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Ohje was für ein roter Markt und für lange Zeit keine Besserung in Sicht 😡
S
Steff1,
26.10.2020 19:31 Uhr
0
Ja anschnallen, geht nach oben
Matu,
26.10.2020 19:27 Uhr
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Wenn das hier Game over ist frag ich mich was du hier noch treibst, wäre für mich Zeitverschwendung ner Leiche zu zusehen....und wenn es so wäre wo sind eure Info's
G
Gast-747484401,
26.10.2020 19:17 Uhr
0
Investierten
G
Gast-747484401,
26.10.2020 19:17 Uhr
0
Jetzt wirds bitter...bitte anschnallen an alle noch investieren
G
Gast-747484401,
26.10.2020 14:21 Uhr
0
Game over
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