Mannkind, Game-Chancer in Sachen Diabetik? (Seite 86)
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ISIN: US56400P7069 · WKN: A2DMZL · Symbol: MNKD
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Es geht Richtung 52-Wochen-Hoch...
Bin hier seit Jahren mit EK 5$ investiert, wenn’s so weiter geht mit den positiven News, bin ich optimistisch wieder +/- 0 zu sein...
Bin hier seit Jahren mit EK 5$ investiert, wenn’s so weiter geht mit den positiven News, bin ich optimistisch wieder +/- 0 zu sein...
Auch als Kunden
Wir haben es uns verdient
Hier gehts um ganz was Anderes, unser Partner UTHR präsentiert das inhalierbare TreT von Mannkind, das wird ein Superdeal:
UNITED THERAPEUTICS ANNOUNCES INCREASE DATA PRESENTATION AT AN AMERICAN THORACIC SOCIETY VIRTUAL SESSION
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Wednesday, June 17, 2020: United Therapeutics Corporation (Nasdaq: UTHR) announced today that key data from the INCREASE study of Tyvaso® (treprostinil) Inhalation Solution in patients suffering from World Health Organization (WHO) Group 3 pulmonary hypertension associated with interstitial lung disease (PH-ILD) will be presented at a Breaking News Session hosted by the American Thoracic Society (ATS) on June 24, 2020.
The virtual presentation, entitled “Inhaled Treprostinil in Interstitial Lung Disease Associated Pulmonary Hypertension: The INCREASE Study” will be given by Dr. Steven D. Nathan, M.D., Director of the Advanced Lung Disease Program and Director of the Lung Transplant Program at Inova Fairfax Hospital. The presentation will take place on Wednesday, June 24, 2020 from 2:53 to 3:18 p.m., Eastern Daylight Time. Additional information about the ATS session, entitled “Breaking News: Clinical Trial Results in Pulmonary Medicine,” including participant registration information, can be found on the ATS International Conference website at https://conference.thoracic.org/program/virtual-clinical-tri… Those interested in viewing the presentation should register free of charge in advance as a replay of the presentation will not be immediately available.
As previously announced on February 24, 2020, Tyvaso increased six-minute walk distance (6MWD) by 21 meters versus placebo (p=0.0043, Hodges-Lehmann estimate) after 16 weeks of treatment. Benefits of Tyvaso were observed across several key subgroups, including etiology of PH-ILD, disease severity, age, gender, baseline hemodynamics, and dose.
Significant improvements were also observed in each of the study’s secondary endpoints, including reduction in the cardiac biomarker NT-proBNP, time to first clinical worsening event, change in peak 6MWD at Week 12, and change in trough 6MWD at week 15. Treatment with Tyvaso of up to 12 breaths per session, four times daily, in the INCREASE study was well tolerated and the safety profile was consistent with previous Tyvaso studies in pulmonary arterial hypertension and known prostacyclin-related adverse events (see the Important Safety Information below under “About Tyvaso”).
United Therapeutics recently submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration seeking to revise the Tyvaso label to reflect the outcome of the INCREASE study.
About INCREASE
INCREASE was a phase III, multicenter, randomized, double-blinded, placebo-controlled, 16-week, parallel group study of Tyvaso in patients with pulmonary hypertension associated with interstitial lung disease. Enrollment into the study was completed in August 2019 with a total of 326 patients. Patients were randomized in a 1:1 Tyvaso (n=163) or placebo (n=163).
The primary endpoint was to evaluate the change in 6MWD measured at peak exposure from Baseline to Week 16.
Secondary objectives of the study included:
• Change in plasma concentration of N-terminal pro-brain natriuretic peptide (NT-proBNP) from Baseline to Week 16
• Time to clinical worsening calculated as the time from randomization until one of the following criteria are met:
o Hospitalization due to a cardiopulmonary indication
o Decrease in 6MWD >15% from Baseline directly related to disease under study, at two consecutive visits, and at least 24 hours apart
o Death (all causes)
o Lung transplantation
• Change in peak 6MWD from Baseline to Week 12
• Change in trough 6MWD from Baseline to Week 15
Exploratory objectives of the study evaluated changes in peak 6MWD at Week 4 and Week 8, changes in quality of life as measured by the St. George’s Respiratory Questionnaire (SGRQ), and change in distance saturation product (DSP). Further exploratory analysis will also be performed on biomarkers and pharmacogenomics from this study.
Additional study results will be made available through scientific disclosure in upcoming peer-reviewed publications.
About TYVASO® (treprostinil) Inhalation Solution
For the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability.
UNITED THERAPEUTICS ANNOUNCES INCREASE DATA PRESENTATION AT AN AMERICAN THORACIC SOCIETY VIRTUAL SESSION
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Wednesday, June 17, 2020: United Therapeutics Corporation (Nasdaq: UTHR) announced today that key data from the INCREASE study of Tyvaso® (treprostinil) Inhalation Solution in patients suffering from World Health Organization (WHO) Group 3 pulmonary hypertension associated with interstitial lung disease (PH-ILD) will be presented at a Breaking News Session hosted by the American Thoracic Society (ATS) on June 24, 2020.
The virtual presentation, entitled “Inhaled Treprostinil in Interstitial Lung Disease Associated Pulmonary Hypertension: The INCREASE Study” will be given by Dr. Steven D. Nathan, M.D., Director of the Advanced Lung Disease Program and Director of the Lung Transplant Program at Inova Fairfax Hospital. The presentation will take place on Wednesday, June 24, 2020 from 2:53 to 3:18 p.m., Eastern Daylight Time. Additional information about the ATS session, entitled “Breaking News: Clinical Trial Results in Pulmonary Medicine,” including participant registration information, can be found on the ATS International Conference website at https://conference.thoracic.org/program/virtual-clinical-tri… Those interested in viewing the presentation should register free of charge in advance as a replay of the presentation will not be immediately available.
As previously announced on February 24, 2020, Tyvaso increased six-minute walk distance (6MWD) by 21 meters versus placebo (p=0.0043, Hodges-Lehmann estimate) after 16 weeks of treatment. Benefits of Tyvaso were observed across several key subgroups, including etiology of PH-ILD, disease severity, age, gender, baseline hemodynamics, and dose.
Significant improvements were also observed in each of the study’s secondary endpoints, including reduction in the cardiac biomarker NT-proBNP, time to first clinical worsening event, change in peak 6MWD at Week 12, and change in trough 6MWD at week 15. Treatment with Tyvaso of up to 12 breaths per session, four times daily, in the INCREASE study was well tolerated and the safety profile was consistent with previous Tyvaso studies in pulmonary arterial hypertension and known prostacyclin-related adverse events (see the Important Safety Information below under “About Tyvaso”).
United Therapeutics recently submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration seeking to revise the Tyvaso label to reflect the outcome of the INCREASE study.
About INCREASE
INCREASE was a phase III, multicenter, randomized, double-blinded, placebo-controlled, 16-week, parallel group study of Tyvaso in patients with pulmonary hypertension associated with interstitial lung disease. Enrollment into the study was completed in August 2019 with a total of 326 patients. Patients were randomized in a 1:1 Tyvaso (n=163) or placebo (n=163).
The primary endpoint was to evaluate the change in 6MWD measured at peak exposure from Baseline to Week 16.
Secondary objectives of the study included:
• Change in plasma concentration of N-terminal pro-brain natriuretic peptide (NT-proBNP) from Baseline to Week 16
• Time to clinical worsening calculated as the time from randomization until one of the following criteria are met:
o Hospitalization due to a cardiopulmonary indication
o Decrease in 6MWD >15% from Baseline directly related to disease under study, at two consecutive visits, and at least 24 hours apart
o Death (all causes)
o Lung transplantation
• Change in peak 6MWD from Baseline to Week 12
• Change in trough 6MWD from Baseline to Week 15
Exploratory objectives of the study evaluated changes in peak 6MWD at Week 4 and Week 8, changes in quality of life as measured by the St. George’s Respiratory Questionnaire (SGRQ), and change in distance saturation product (DSP). Further exploratory analysis will also be performed on biomarkers and pharmacogenomics from this study.
Additional study results will be made available through scientific disclosure in upcoming peer-reviewed publications.
About TYVASO® (treprostinil) Inhalation Solution
For the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability.
Antwort auf Beitrag Nr.: 64.035.201 von Signal999 am 16.06.20 16:18:25Den Hype um Covid 19 hatte vorher keiner auf dem Schirm, das ändert die Regeln gewaltig und auch die Möglichkeiten von Inhallationsprodukten werden komplett neu bewertet.
Was vorher 0 Interesse einbrachte kommt jetzt in den Fokus---so ist das manchmal
Das dürfte auch Begehrlichkeiten in Sachen möglicher Übernahme wecken?? 😎
Was vorher 0 Interesse einbrachte kommt jetzt in den Fokus---so ist das manchmal
Das dürfte auch Begehrlichkeiten in Sachen möglicher Übernahme wecken?? 😎
Trading Spotlight
wenn das "Teil" heute wieder runter geht, bin ich erst mal raus. Was soll den groß passieren?
Die Zahlen sind seit ewigen Zeiten gleich und gute Nachrichten scheint die Investoren nicht zu interessieren
Die Zahlen sind seit ewigen Zeiten gleich und gute Nachrichten scheint die Investoren nicht zu interessieren
Sehe auch wieder etwas optimistischer in die Zukunft. Trotzdem ist es noch ein weiter Weg.
Kein Big Player kommt hier aus der Deckung um unterstützend zu wirken.Andere Bio Pharma Firmen werden ruckzuck geschluckt, hier aber kommt nichts.Trotzdem denke ich, dass Fortschritt sich auf Dauer nicht aufhalten lässt.
Schaumer mal was noch so kommt.
Grüße.
Kein Big Player kommt hier aus der Deckung um unterstützend zu wirken.Andere Bio Pharma Firmen werden ruckzuck geschluckt, hier aber kommt nichts.Trotzdem denke ich, dass Fortschritt sich auf Dauer nicht aufhalten lässt.
Schaumer mal was noch so kommt.
Grüße.
https://investors.mannkindcorp.com/news-releases/news-releas…
Jetzt wird mir auch klar, warum die Verschreibungszahlen nicht stark gestiegen sind. Man hatte wohl Bedenken das durch die Einnahme die Lungenfunktion eingeschränkt werden könnte. Wenn ich das richtig lese, konnte in den Studien dazu nichts negatives festgestellt werden. :-)
Jetzt bin ich echt gespannt wie Afrezzar weiter geht, + die Phantasie neuer Inhallationsprodukte die ggf.als Ansatz zur Behandlung von Covid 19 Patienten dienen könnten???
VG
Jetzt wird mir auch klar, warum die Verschreibungszahlen nicht stark gestiegen sind. Man hatte wohl Bedenken das durch die Einnahme die Lungenfunktion eingeschränkt werden könnte. Wenn ich das richtig lese, konnte in den Studien dazu nichts negatives festgestellt werden. :-)
Jetzt bin ich echt gespannt wie Afrezzar weiter geht, + die Phantasie neuer Inhallationsprodukte die ggf.als Ansatz zur Behandlung von Covid 19 Patienten dienen könnten???
VG
Drüben galten die 1,64 Usd
Bitte den Gewichtsverlust der Patienten beachten, der hat ne Menge positiver Nebeneffekte für Herz Kreislauferkrankungen---super Nachrichten wie ich finde :-)
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Mannkind, Game-Chancer in Sachen Diabetik?
