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ISIN: US8902608624 · WKN: A3DL8Q · Symbol: TPM
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Lange nicht mehr so einen interessanten Wert gesehen. Hab alles verkauft und bin hier all in👍
Zahlen heute erwartet
Zahlen heute erwartet
Antwort auf Beitrag Nr.: 60.110.506 von Fusselsocke am 15.03.19 13:26:11Bin der Meinung wir knacken gleich die 3,50👍
Antwort auf Beitrag Nr.: 60.110.647 von Fusselsocke am 15.03.19 13:43:16
denke du hast sicher 2,50 gemeint.
Zitat von Fusselsocke: Bin der Meinung wir knacken gleich die 3,50👍
denke du hast sicher 2,50 gemeint.
Antwort auf Beitrag Nr.: 60.111.304 von bmuesli am 15.03.19 14:48:16Nein, ich meine 3,50!
Die Amis haben doch grad 20 min auf😏
Die Amis haben doch grad 20 min auf😏
Antwort auf Beitrag Nr.: 60.111.337 von Fusselsocke am 15.03.19 14:50:20
wie viele Reversesplits hat es denn da in den letzten Jahren schon gegeben? Das müssen ja schon einige gewesen sein wenn man sich den Chart anschaut.
Zitat von Fusselsocke: Nein, ich meine 3,50!
Die Amis haben doch grad 20 min auf😏
wie viele Reversesplits hat es denn da in den letzten Jahren schon gegeben? Das müssen ja schon einige gewesen sein wenn man sich den Chart anschaut.
Trading Spotlight
Antwort auf Beitrag Nr.: 60.111.385 von bmuesli am 15.03.19 14:56:33Ich bleibe dabei: das hier wird Gold wert sein
Antwort auf Beitrag Nr.: 60.112.486 von Fusselsocke am 15.03.19 16:22:03es bleibt dir auch nichts anderes übrig wenn du wirklich all in bist. 
Du solltest dir auch mal Epigenomics anschauen denke da könnte durchaus auch enormes Potential vorhanden sein.
Du solltest dir auch mal Epigenomics anschauen denke da könnte durchaus auch enormes Potential vorhanden sein.
Antwort auf Beitrag Nr.: 60.113.386 von bmuesli am 15.03.19 17:43:01Das stimmt😔 leider ging es eher runter als hoch. ich rechne aber weiterhin mit einem sehr guten Kursverlauf und bleibe „all in“
Antwort auf Beitrag Nr.: 60.148.788 von Fusselsocke am 20.03.19 10:37:06denke aber die Monsanto Nachricht wird erst einmal die Biotechs belasten.
Antwort auf Beitrag Nr.: 60.110.506 von Fusselsocke am 15.03.19 13:26:11
https://www.tonixpharma.com/news-events/press-releases/detai…
NEW YORK, March 18, 2019 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix, or the Company), a clinical-stage biopharmaceutical company focused on developing pharmaceutical products to treat serious neuropsychiatric conditions and biological products to improve biodefense, today announced financial results for the fourth quarter and full year ended December 31, 2018, and an overview of recent operational highlights.
“Looking forward into 2019, we are excited about the recent initiation of our new Phase 3 study of Tonmya for PTSD. The RECOVERY study incorporates learnings and analyses from our Phase 2 and Phase 3 studies in over 500 military-related PTSD participants, and is intended to support the registration of Tonmya for PTSD. We look forward to topline data in the first half of 2020,” said Seth Lederman, M.D., President and Chief Executive Officer. “In addition to Tonmya for PTSD, we maintain a strong and growing pipeline of product candidates, including TNX-102 SL as a bedtime treatment for fibromyalgia and agitation in Alzheimer’s disease, and TNX-601 as a daytime treatment for PTSD and neurocognitive dysfunction associated with corticosteroid use, a potential indication.”
Recent Clinical and Regulatory Highlights
•Enrolled first participant in the Phase 3 RECOVERY study of Tonmya for the treatment of PTSD in March. This pivotal efficacy study incorporates several innovative design features, based on analyses of data from our prior PTSD trials. In November 2018, we received Food and Drug Administration (FDA) acceptance of the study design, which includes participants who have experienced civilian traumas in addition to those with military-related traumas, and restricts enrollment to participants who experienced an index trauma within nine years of screening.
•Completed a Clinical Guidance meeting with the FDA in March to discuss the fibromyalgia registration plan for TNX-102 SL and a new Phase 3 study to support this indication.
•Received European use patent issuance for TNX-601 (tianeptine oxalate) for the treatment of neurocognitive dysfunction associated with corticosteroids use, a potential indication. TNX-601 is also being developed as a daytime treatment for PTSD. A Phase 1 pharmacokinetic study of proprietary tianeptine oxalate formulations will be conducted outside of the U.S. and the result is expected in the second half of 2019.
•Successfully completed a Phase 1 pivotal bridging pharmacokinetic study of TNX-102 SL in 2018, the data for which was deemed sufficient by the FDA to support the 505(b)(2) NDA submission for Tonmya and TNX-102 SL.
Recent Corporate Highlights
•Strengthened our balance sheet in December 2018 by completing a public equity offering. The transaction resulted in gross proceeds of $15.9 million, including the over-allotment proceeds, which will be used, in part, to fund the new Phase 3 RECOVERY trial of Tonmya for PTSD.
•Announced a Share Repurchase Program to buy up to $2 million in value of the Company’s outstanding stock from time to time.
Fourth Quarter 2018 Financial Results
Research and development expenses for the fourth quarter of 2018 totaled $5.1 million, compared to $3.6 million for the same period in 2017. This increase is due primarily to costs related to the close-out of the Phase 3 HONOR study as well as other activities related to the PTSD program.
General and administrative expenses for the fourth quarter of 2018 were $2.6 million, compared to $1.9 million for the same period in 2017. This increase is due primarily to an increase in legal fees related to patent prosecution, as well as an increase in investor and public relations expenses due to increased investor meetings.
Net loss available to common stockholders was $10.9 million, or $6.10 per share, for the fourth quarter of 2018, compared to net loss of $5.5 million, or $7.07 per share, for the fourth quarter of 2017. In addition to the factors above, fourth quarter 2018 net loss available to common stockholders was impacted by a one-time, non-cash preferred stock deemed dividend in the fourth quarter of 2018. The weighted average common shares outstanding, basic and diluted for the fourth quarter of 2018 was 1,778,524 shares. The weighted average common shares outstanding, basic and diluted for the fourth quarter of 2017 was 750,804 shares.
As of March 13, 2019, all Series A convertible preferred stock had been converted into common stock. Total common stock outstanding as of March 13, 2019 was 6,089,728.
Full Year 2018 Financial Results
Research and development expenses for full year 2018 totaled $17.6 million, compared to $13.3 million for full year 2017. This increase is due primarily to the continued development work related to the PTSD program, including the completion of the NDA-required pivotal bridging pharmacokinetic study of TNX-102 SL in 2018.
General and administrative expenses for full year 2018 were $8.8 million, compared to $8.0 mill
Zitat von Fusselsocke: Lange nicht mehr so einen interessanten Wert gesehen. Hab alles verkauft und bin hier all in👍
Zahlen heute erwartet
https://www.tonixpharma.com/news-events/press-releases/detai…
NEW YORK, March 18, 2019 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix, or the Company), a clinical-stage biopharmaceutical company focused on developing pharmaceutical products to treat serious neuropsychiatric conditions and biological products to improve biodefense, today announced financial results for the fourth quarter and full year ended December 31, 2018, and an overview of recent operational highlights.
“Looking forward into 2019, we are excited about the recent initiation of our new Phase 3 study of Tonmya for PTSD. The RECOVERY study incorporates learnings and analyses from our Phase 2 and Phase 3 studies in over 500 military-related PTSD participants, and is intended to support the registration of Tonmya for PTSD. We look forward to topline data in the first half of 2020,” said Seth Lederman, M.D., President and Chief Executive Officer. “In addition to Tonmya for PTSD, we maintain a strong and growing pipeline of product candidates, including TNX-102 SL as a bedtime treatment for fibromyalgia and agitation in Alzheimer’s disease, and TNX-601 as a daytime treatment for PTSD and neurocognitive dysfunction associated with corticosteroid use, a potential indication.”
Recent Clinical and Regulatory Highlights
•Enrolled first participant in the Phase 3 RECOVERY study of Tonmya for the treatment of PTSD in March. This pivotal efficacy study incorporates several innovative design features, based on analyses of data from our prior PTSD trials. In November 2018, we received Food and Drug Administration (FDA) acceptance of the study design, which includes participants who have experienced civilian traumas in addition to those with military-related traumas, and restricts enrollment to participants who experienced an index trauma within nine years of screening.
•Completed a Clinical Guidance meeting with the FDA in March to discuss the fibromyalgia registration plan for TNX-102 SL and a new Phase 3 study to support this indication.
•Received European use patent issuance for TNX-601 (tianeptine oxalate) for the treatment of neurocognitive dysfunction associated with corticosteroids use, a potential indication. TNX-601 is also being developed as a daytime treatment for PTSD. A Phase 1 pharmacokinetic study of proprietary tianeptine oxalate formulations will be conducted outside of the U.S. and the result is expected in the second half of 2019.
•Successfully completed a Phase 1 pivotal bridging pharmacokinetic study of TNX-102 SL in 2018, the data for which was deemed sufficient by the FDA to support the 505(b)(2) NDA submission for Tonmya and TNX-102 SL.
Recent Corporate Highlights
•Strengthened our balance sheet in December 2018 by completing a public equity offering. The transaction resulted in gross proceeds of $15.9 million, including the over-allotment proceeds, which will be used, in part, to fund the new Phase 3 RECOVERY trial of Tonmya for PTSD.
•Announced a Share Repurchase Program to buy up to $2 million in value of the Company’s outstanding stock from time to time.
Fourth Quarter 2018 Financial Results
Research and development expenses for the fourth quarter of 2018 totaled $5.1 million, compared to $3.6 million for the same period in 2017. This increase is due primarily to costs related to the close-out of the Phase 3 HONOR study as well as other activities related to the PTSD program.
General and administrative expenses for the fourth quarter of 2018 were $2.6 million, compared to $1.9 million for the same period in 2017. This increase is due primarily to an increase in legal fees related to patent prosecution, as well as an increase in investor and public relations expenses due to increased investor meetings.
Net loss available to common stockholders was $10.9 million, or $6.10 per share, for the fourth quarter of 2018, compared to net loss of $5.5 million, or $7.07 per share, for the fourth quarter of 2017. In addition to the factors above, fourth quarter 2018 net loss available to common stockholders was impacted by a one-time, non-cash preferred stock deemed dividend in the fourth quarter of 2018. The weighted average common shares outstanding, basic and diluted for the fourth quarter of 2018 was 1,778,524 shares. The weighted average common shares outstanding, basic and diluted for the fourth quarter of 2017 was 750,804 shares.
As of March 13, 2019, all Series A convertible preferred stock had been converted into common stock. Total common stock outstanding as of March 13, 2019 was 6,089,728.
Full Year 2018 Financial Results
Research and development expenses for full year 2018 totaled $17.6 million, compared to $13.3 million for full year 2017. This increase is due primarily to the continued development work related to the PTSD program, including the completion of the NDA-required pivotal bridging pharmacokinetic study of TNX-102 SL in 2018.
General and administrative expenses for full year 2018 were $8.8 million, compared to $8.0 mill
Antwort auf Beitrag Nr.: 60.174.306 von bmuesli am 22.03.19 17:39:46Das sieht doch wieder besser aus und gestern Schlusskurs über 2,50 Dollar.
Antwort auf Beitrag Nr.: 60.214.454 von Fusselsocke am 28.03.19 05:52:08und du bist bei so einem wert ernsthaft all in gegangen?
crass...ja das könnte was werden hier aber man ist ja schon mal
fast gescheitert...hm...also ich bin auch dabei aber all in...nee echt nicht
naja muss jeder selbst wissen was zu tun ist!
crass...ja das könnte was werden hier aber man ist ja schon mal
fast gescheitert...hm...also ich bin auch dabei aber all in...nee echt nicht
naja muss jeder selbst wissen was zu tun ist!
Antwort auf Beitrag Nr.: 60.236.638 von suedama am 30.03.19 15:32:28Hab 8.000 Stück. Und es wird sich lohnen
Antwort auf Beitrag Nr.: 60.248.748 von Fusselsocke am 01.04.19 19:51:21so viele hab ich nicht...aber dan geht das ja noch mit dem all in!
Antwort auf Beitrag Nr.: 60.253.572 von suedama am 02.04.19 10:49:10Darauf habe ich gewartet 
Encouraging FDA Meeting Minutes Support Phase 3 Development of TNX-102 SL 5.6 mg in Fibromyalgia
NEW YORK, April 04, 2019 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company focused on developing pharmaceutical products to treat serious neuropsychiatric and central nervous system conditions, and biological products to improve biodefense, announced today the expansion of the TNX-102 SL 5.6 mg program beyond posttraumatic stress disorder (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 U.S. Food and Drug Administration (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 (2.8 mg) 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 (2 x 2.8 mg tablets) 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.
“We are very pleased with the outcomes of our recent discussion with the FDA to advance the fibromyalgia Phase 3 clinical program with TNX-102 SL 5.6 mg with the potential to expand the product labeling beyond PTSD. The FDA’s acceptance of the well-established safety information of currently-marketed oral cyclobenzaprine products and their agreement that TNX-102 SL 5.6 mg long-term exposure data from our PTSD studies may support the fibromyalgia indication are very reassuring. We are looking forward to submitting a final Phase 3 protocol and statistical analysis plan for FDA acceptance prior to study initiation,” said Seth Lederman, M.D., Tonix's President and Chief Executive Officer. “We have extensive clinical experience and data collected over the past seven years with TNX-102 SL in fibromyalgia and PTSD studies. In addition to the synergy between these two development programs, we are very pleased with the FDA's clear guidance and support to help advance our lead product candidate, TNX-102 SL, in fibromyalgia and PTSD toward NDA approvals.”
Dr. Lederman continued, “There is a pressing need for new drugs to treat patients with fibromyalgia, especially considering that approximately one-third of fibromyalgia patients are on chronic opiates. Tonix could potentially address this need for a non-opiate, non-addictive analgesic for fibromyalgia and possibly other indications in which improvement in sleep quality can indirectly provide clinical benefit to the primary symptoms.”
About Fibromyalgia
Fibromyalgia is a chronic neurobiological disorder that is thought to result from amplified sensory and pain signaling. Fibromyalgia afflicts five to 15 million Americans, and physicians and patients report widespread dissatisfaction with currently marketed products. Common symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled.
Encouraging FDA Meeting Minutes Support Phase 3 Development of TNX-102 SL 5.6 mg in Fibromyalgia
NEW YORK, April 04, 2019 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company focused on developing pharmaceutical products to treat serious neuropsychiatric and central nervous system conditions, and biological products to improve biodefense, announced today the expansion of the TNX-102 SL 5.6 mg program beyond posttraumatic stress disorder (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 U.S. Food and Drug Administration (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 (2.8 mg) 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 (2 x 2.8 mg tablets) 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.
“We are very pleased with the outcomes of our recent discussion with the FDA to advance the fibromyalgia Phase 3 clinical program with TNX-102 SL 5.6 mg with the potential to expand the product labeling beyond PTSD. The FDA’s acceptance of the well-established safety information of currently-marketed oral cyclobenzaprine products and their agreement that TNX-102 SL 5.6 mg long-term exposure data from our PTSD studies may support the fibromyalgia indication are very reassuring. We are looking forward to submitting a final Phase 3 protocol and statistical analysis plan for FDA acceptance prior to study initiation,” said Seth Lederman, M.D., Tonix's President and Chief Executive Officer. “We have extensive clinical experience and data collected over the past seven years with TNX-102 SL in fibromyalgia and PTSD studies. In addition to the synergy between these two development programs, we are very pleased with the FDA's clear guidance and support to help advance our lead product candidate, TNX-102 SL, in fibromyalgia and PTSD toward NDA approvals.”
Dr. Lederman continued, “There is a pressing need for new drugs to treat patients with fibromyalgia, especially considering that approximately one-third of fibromyalgia patients are on chronic opiates. Tonix could potentially address this need for a non-opiate, non-addictive analgesic for fibromyalgia and possibly other indications in which improvement in sleep quality can indirectly provide clinical benefit to the primary symptoms.”
About Fibromyalgia
Fibromyalgia is a chronic neurobiological disorder that is thought to result from amplified sensory and pain signaling. Fibromyalgia afflicts five to 15 million Americans, and physicians and patients report widespread dissatisfaction with currently marketed products. Common symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled.
Antwort auf Beitrag Nr.: 60.276.771 von Fusselsocke am 04.04.19 13:52:19bei 2,70 heute raus. Wenn Rücksetzer, dann gehe ich wieder neu rein.
Antwort auf Beitrag Nr.: 60.279.243 von Fusselsocke am 04.04.19 17:05:24also doch raus...nix mehr mit all in...
Antwort auf Beitrag Nr.: 60.324.664 von suedama am 10.04.19 18:16:02ich werde hier bald wieder einsteigen. Rücksetzer kam genau richtig. Muss aber noch meinen Anstieg bei Histogenics abwarten, denn da ist meiner Meinung nach schneller ein Rebound drin
Und mal wieder ein Lebenszeichen...😏
Eine Kurs-Entwicklung wie bei Axsome wäre dufte. 🤤
Die habe ich vorletztes Jahr leider mir Verlust viel zu früh verkauft...😣
Eine Kurs-Entwicklung wie bei Axsome wäre dufte. 🤤
Die habe ich vorletztes Jahr leider mir Verlust viel zu früh verkauft...😣
Bei dem Hype, den die Mehrheit in diesem Portal bei vermeintlich kleineren Biotech-Werten veranstaltet, wundert es mich dann doch, warum nicht mehrere Recherche-Freaks auf das Schnäppchen mit dem größten Potential - unter Aufbringung von mindestens einem halben Jahr Geduld - aufmerksam werden. Diese Aktien ist am Boden angelangt, völlig zu unrecht. Der Verlauf der entscheidenden beiden Studien ist überragend und das Interesse von großen Konkurrenzfirmen groß. Durch die Betroffenheit, was Fibromyalgie betrifft im nahen Umfeld, kann ich sagen, dass hier mit einem Durchbruch zu rechnen ist. Die Kurschance ist hier ohne Übertreibung in der Endphase zur Zulassung mit Aussicht auf Übernahme weit über 1000%!!! Vorgestellt wurde das Unternehmen ja bereits. Übrigens zeigen sich Parallelen zu Adamis, allerdings beschäftigt man sich hier mit der Überdosierung von Kokain im Einzelnen. Es mag nach Zockerei aussehen, am Ende aber wird man wohl erkennen, dass hier die Aussichten durchaus konservativer Natur, was das Risiko betrifft, aussehen. Die Finanzspritzen sollten auch nicht ausbleiben, da man sehr speziell mit der FDA zusammenarbeitet. Traut Euch!
ist hier noch was zu holen? Die Pipline sieht eigentlich gut aus für die nächsten Monate.
Antwort auf Beitrag Nr.: 62.280.896 von spezi1000 am 04.01.20 13:06:38 hi,
klaro,
ab heute geht die Lucy ab................
M.
klaro,
ab heute geht die Lucy ab................
M.
Neueste Empfehlung von Biohero 😉
Naja, um meinen EK von 367$ zu sehen, muß sie noch ein wenig steigen 😜
Bin daher am Überlegen, zu verbilligen und EK zu senken...
Naja, um meinen EK von 367$ zu sehen, muß sie noch ein wenig steigen 😜
Bin daher am Überlegen, zu verbilligen und EK zu senken...
Hm, Thread hier nicht im Biotechnologie-Forum?! 🤔
Kann den mal jemand da hin verschieben? 😉 Danke 🙏
Kann den mal jemand da hin verschieben? 😉 Danke 🙏
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Es geht schon wieder los
