Rebound-Chance nach verpassten Phase-3 Studienzielen - Die letzten 30 Beiträge
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ISIN: US6033802058 · WKN: A3DMH5 · Symbol: NERV
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Letzter Kurs 02:00:00 Nasdaq
Werte aus der Branche Biotechnologie
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 1,9000 | +59,66 | |
| 0,5922 | +44,44 | |
| 7,3500 | +43,84 | |
| 11,690 | +40,84 | |
| 0,7000 | +36,69 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 10,110 | -13,44 | |
| 8,2200 | -13,47 | |
| 7,6100 | -17,20 | |
| 1,6100 | -18,27 | |
| 2,1200 | -21,77 |
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FeedbackNERV: Roluperidon als Monotherapie für Schizophrenie vor Zulassung?
4,6 Millionen float, 1,6 Millionen short, SI über 34%, CTB über 81% (Quelle: Fintel.io)Das Unternehmen beantragte am 22. August die Zulassung für Roluperidon bei der FDA.
9 $pro Aktie in cash! (Quelle: NERV Inverstot Relations Website).
Ich probiere hier mal eine kleine Position...
Booooom 🐒
Heute ging's bis $ 3:
Dann versperrte die drückende Kante den Weg.
🎵
Dann versperrte die drückende Kante den Weg.
🎵
Bei Minerva Neurosciences Inc hat der MACD im Daily die Signallinie nach oben gekreuzt.
💡
Antwort auf Beitrag Nr.: 65.943.147 von ooy am 04.12.20 06:46:37Sollte die Äquivalenzstudie positiv ausfallen sehe ich weniger Probleme (natürlich wäre es schöner gewesen das nächste Wundermittel auf den Markt bringen zu können), ansonsten halt nochmal P3, das war aber schon bekannt. Ist halt bisschen wie zocken, deshalb auch nur überschaubare Beträge im Einsatz 😎.
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Antwort auf Beitrag Nr.: 65.941.389 von Aljo am 03.12.20 21:20:03Viel Glueck, ich sehe das eher negativ.
Minerva Neurosciences Announces Outcome of Type C Meeting with FDA and Next Steps in the Development of Roluperidone Nachrichtenquelle: globenewswire | 01.12.2020, 14:00 | 217 | 0 | 0 WALTHAM, Mass., Dec. 01, 2020 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that it has received official meeting minutes from the November 10, 2020 Type C meeting with the U.S. Food and Drug Administration (FDA) regarding development of roluperidone for treatment of negative symptoms in schizophrenia. The objective of this meeting was to obtain FDA input regarding the roluperidone data package and its readiness to support a New Drug Application (NDA) submission. The two main topics addressed during the meeting were: Anzeige Ausblick auf 2021 PULLACH (DJE Kapital AG) – 2020 löste Corona den schärfsten Börseneinbruch weltweit in der Wirtschaftsgeschichte aus. Er traf die Welt in einer verletzlichen Situation, in der sich die Konjunktur bereits international deutlich abschwächte, so dass die Pandemie den bestehenden Abwärtstrend noch einmal massiv verstärkte. Mehr erfahren powered by finative 1. Readiness for submission of NDA Minerva requested confirmation from FDA that, based on the totality of evidence, the data from the MIN-101C03 (Phase 2b) and MIN-101C07 (Phase 3) studies constitute substantial evidence of the effectiveness of the 64 milligrams (mg) dose of roluperidone for the treatment of negative symptoms in schizophrenia and would warrant review of an NDA submission. FDA advised that the Phase 2b study is problematic because it did not use the commercial formulation of roluperidone and was conducted solely outside of the United States. In addition, FDA commented that the Phase 3 study does not appear to be capable of supporting substantial evidence of effectiveness, because neither dose of roluperidone showed a statistically significant separation from placebo at Week 12 in the intent-to-treat (ITT) analysis set. FDA cautioned that an NDA submission based on the current data from the Phase 2b and Phase 3 studies would be highly unlikely to be filed and that, at a minimum, there would be substantial review issues due to the lack of two adequate and well-controlled trials to support efficacy claims for this indication. FDA acknowledged that the data from the Phase 2b and Phase 3 studies appear to show promising signals and encouraged Minerva to continue the development of roluperidone for treatment of negative symptoms in schizophrenia, which FDA confirmed is an unmet need. Minerva recognizes FDA’s comments but believes they can be addressed based on published regulatory guidance and precedents. The company has comparable pharmacokinetic data for the formulations used in Phase 2b and Phase 3 (the commercial formulation) and intends to perform a pivotal bioequivalence study to bridge the two formulations. In addition, Minerva believes the Phase 3 study has shown that US data and ex-US data are comparable, and that many precedents exist where drugs were approved by FDA based solely on ex-US data. Minerva believes that, in the Phase 3 study, results from the modified ITT (mITT) analysis set that excludes patients with implausible behavioral and physiological data from one site (17 of a total of 513 patients) address the lack of separation at Week 12.
Minerva Neurosciences Announces Outcome of Type C Meeting with FDA and Next Steps in the Development of Roluperidone | wallstreet-online.de - Vollständiger Artikel unter:
https://www.wallstreet-online.de/nachricht/13220187-minerva-…
Minerva Neurosciences Announces Outcome of Type C Meeting with FDA and Next Steps in the Development of Roluperidone Nachrichtenquelle: globenewswire | 01.12.2020, 14:00 | 217 | 0 | 0 WALTHAM, Mass., Dec. 01, 2020 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that it has received official meeting minutes from the November 10, 2020 Type C meeting with the U.S. Food and Drug Administration (FDA) regarding development of roluperidone for treatment of negative symptoms in schizophrenia. The objective of this meeting was to obtain FDA input regarding the roluperidone data package and its readiness to support a New Drug Application (NDA) submission. The two main topics addressed during the meeting were: Anzeige Ausblick auf 2021 PULLACH (DJE Kapital AG) – 2020 löste Corona den schärfsten Börseneinbruch weltweit in der Wirtschaftsgeschichte aus. Er traf die Welt in einer verletzlichen Situation, in der sich die Konjunktur bereits international deutlich abschwächte, so dass die Pandemie den bestehenden Abwärtstrend noch einmal massiv verstärkte. Mehr erfahren powered by finative 1. Readiness for submission of NDA Minerva requested confirmation from FDA that, based on the totality of evidence, the data from the MIN-101C03 (Phase 2b) and MIN-101C07 (Phase 3) studies constitute substantial evidence of the effectiveness of the 64 milligrams (mg) dose of roluperidone for the treatment of negative symptoms in schizophrenia and would warrant review of an NDA submission. FDA advised that the Phase 2b study is problematic because it did not use the commercial formulation of roluperidone and was conducted solely outside of the United States. In addition, FDA commented that the Phase 3 study does not appear to be capable of supporting substantial evidence of effectiveness, because neither dose of roluperidone showed a statistically significant separation from placebo at Week 12 in the intent-to-treat (ITT) analysis set. FDA cautioned that an NDA submission based on the current data from the Phase 2b and Phase 3 studies would be highly unlikely to be filed and that, at a minimum, there would be substantial review issues due to the lack of two adequate and well-controlled trials to support efficacy claims for this indication. FDA acknowledged that the data from the Phase 2b and Phase 3 studies appear to show promising signals and encouraged Minerva to continue the development of roluperidone for treatment of negative symptoms in schizophrenia, which FDA confirmed is an unmet need. Minerva recognizes FDA’s comments but believes they can be addressed based on published regulatory guidance and precedents. The company has comparable pharmacokinetic data for the formulations used in Phase 2b and Phase 3 (the commercial formulation) and intends to perform a pivotal bioequivalence study to bridge the two formulations. In addition, Minerva believes the Phase 3 study has shown that US data and ex-US data are comparable, and that many precedents exist where drugs were approved by FDA based solely on ex-US data. Minerva believes that, in the Phase 3 study, results from the modified ITT (mITT) analysis set that excludes patients with implausible behavioral and physiological data from one site (17 of a total of 513 patients) address the lack of separation at Week 12.
Minerva Neurosciences Announces Outcome of Type C Meeting with FDA and Next Steps in the Development of Roluperidone | wallstreet-online.de - Vollständiger Artikel unter:
https://www.wallstreet-online.de/nachricht/13220187-minerva-…
Antwort auf Beitrag Nr.: 65.914.311 von ooy am 02.12.20 07:07:19Hab noch 2 Orders drinnen 1x bei 1,80$ und bei 1,15$ schauen wir mal.
Also ich bin wie gesagt gestern bei 2,92 $ eingestiegen.
Danach ging es bis 3,02 hoch und AH noch auf 2,89 runter. Jetzt aktuell im Pre bei 3,05 $
Risiko ist es in jedem Fall. Das muss jeder für sich selbst abschätzen.
Danach ging es bis 3,02 hoch und AH noch auf 2,89 runter. Jetzt aktuell im Pre bei 3,05 $
Risiko ist es in jedem Fall. Das muss jeder für sich selbst abschätzen.
...und jetzt?
Sollte man es wagen??
Was meint Ihr??
Sollte man es wagen??
Was meint Ihr??
Meine natürlich 2,92$
Boden gefunden, auf geht wieder nach oben. Bei 3,02 $ rein, mal gucken wie weit es geht. Swing....
Ist hier noch wer Investiert ? Ich selbst bin seit 3,2$ mit dabei 🚀
https://www.prnewswire.com/news-releases/the-schizophrenia-m…
https://www.raps.org/news-and-articles/news-articles/2020/11…
https://www.prnewswire.com/news-releases/the-schizophrenia-m…
https://www.raps.org/news-and-articles/news-articles/2020/11…
Mal schauen was heute nach dem Webcast passiert morgens in USA...alles noch offen - ich würde sagen zwischen 3-6$ heute intraday alles möglich je nachdem wie sie jetzt die Studienergebnisse analysiert haben und das weitere Vorgehen sein wird.
Hier geht ja ordentlich die Post ab
Webcast auf Freitag dieser Woche verschoben...heute wieder massive Kursbewegungen bei sehr hohen Umsätzen...läuft weiterhin. Ich habe einen Teil meiner Einsätze rausgenommen um Gewinne abzusichern😎.
https://www.fool.com/investing/2020/05/29/heres-why-minerva-…
Auch interessant, doch wie du sagst am Montag wissen wir mehr.. Ich setz mal ne kleine Order
Auch interessant, doch wie du sagst am Montag wissen wir mehr.. Ich setz mal ne kleine Order
The company will hold a webcast event on Monday, June 1, 2020 at 8:30 a.m. to discuss additional data from this study and to provide further insight into the roluperidone Phase 3 trial.
Dann wissen wir wieder etwas mehr...😎
Dann wissen wir wieder etwas mehr...😎
Jetzt komme ich zum eigentlichen Trigger warum ich selbst mit 6K bei 2,5$ am Freitag in diese Aktie eingestiegen bin bzgl. Rebound - inzwischen ist die Aktie wieder geringfügig im „Erholungsmodus“ bis ca. 4$ AH an der Nasdaq...:
“As someone who has spent his career studying everyday functioning in schizophrenia, I see disability as the most important treatment target for people with schizophrenia,” stated Philip Harvey, Ph.D., Leonard M. Miller Professor of Psychiatry and Director of the Division of Psychology at the University of Miami Miller School of Medicine. “The substantial improvements in the PSP scale with the 64 mg dose are tremendously encouraging. These study results represent a very important outcome in a study of a potential treatment of negative symptoms, one of the most important drivers of everyday disability and a critical unmet medical need for patients with schizophrenia. The consistency in treatment effects, in terms of overall negative symptoms and of the most important subtype, reduced emotional experience, between the previous Phase 2b study and the current one is encouraging. The increased placebo effect from the first to second study seems to be the only reason that the study did not meet its primary endpoint.”
Minerva Neurosciences Announces Results From Phase 3 Trial of Roluperidone (MIN-101) for Treatment of Negative Symptoms in Schizophrenia | wallstreet-online.de - Vollständiger Artikel unter:
https://www.wallstreet-online.de/nachricht/12578711-minerva-…
“As someone who has spent his career studying everyday functioning in schizophrenia, I see disability as the most important treatment target for people with schizophrenia,” stated Philip Harvey, Ph.D., Leonard M. Miller Professor of Psychiatry and Director of the Division of Psychology at the University of Miami Miller School of Medicine. “The substantial improvements in the PSP scale with the 64 mg dose are tremendously encouraging. These study results represent a very important outcome in a study of a potential treatment of negative symptoms, one of the most important drivers of everyday disability and a critical unmet medical need for patients with schizophrenia. The consistency in treatment effects, in terms of overall negative symptoms and of the most important subtype, reduced emotional experience, between the previous Phase 2b study and the current one is encouraging. The increased placebo effect from the first to second study seems to be the only reason that the study did not meet its primary endpoint.”
Minerva Neurosciences Announces Results From Phase 3 Trial of Roluperidone (MIN-101) for Treatment of Negative Symptoms in Schizophrenia | wallstreet-online.de - Vollständiger Artikel unter:
https://www.wallstreet-online.de/nachricht/12578711-minerva-…
WALTHAM, Mass., May 29, 2020 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, announced today that the Phase 3 trial of roluperidone to treat negative symptoms in schizophrenia did not meet its primary (reduction in PANSS Marder Negative Symptoms Factor Score or NSFS) and key secondary (improvement in the Personal and Social Performance Scale Total Score or PSP) endpoints.
Minerva Neurosciences Announces Results From Phase 3 Trial of Roluperidone (MIN-101) for Treatment of Negative Symptoms in Schizophrenia | wallstreet-online.de - Vollständiger Artikel unter:
https://www.wallstreet-online.de/nachricht/12578711-minerva-…
Es wurden sowohl die primary als auch key secondary endpoints vs. Placebo verpasst.
Das hört sich primär natürlich sehr schlecht an...deswegen auch der krasse Abverkauf bis phasenweise unter 2$...
Minerva Neurosciences Announces Results From Phase 3 Trial of Roluperidone (MIN-101) for Treatment of Negative Symptoms in Schizophrenia | wallstreet-online.de - Vollständiger Artikel unter:
https://www.wallstreet-online.de/nachricht/12578711-minerva-…
Es wurden sowohl die primary als auch key secondary endpoints vs. Placebo verpasst.
Das hört sich primär natürlich sehr schlecht an...deswegen auch der krasse Abverkauf bis phasenweise unter 2$...
Kapitaler Absturz nach Studiendaten am Freitag - phasenweise um die 80% bei extrem hohen Umsätzen in USA.
Ich sehe hier durchaus Chancen für einen gewissen Rebound - deswegen Threaderöffnung.
Weitere Infos folgen...
Ich sehe hier durchaus Chancen für einen gewissen Rebound - deswegen Threaderöffnung.
Weitere Infos folgen...
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