Hoffe, daß es jetzt dann so richtig losgeht! :-)
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Resverlogix Presents Important New Data at the Annual American Society of Nephrology Kidney Week Conference
13:05
... (automatisch gekürzt) ...
http://www.prnewswire.com/news-releases/...-conference-543506772.html
Zeitpunkt: 09.11.15 15:24
Aktion: Kürzung des Beitrages
Kommentar: Urheberrechtsverletzung, ggf. Link-Einfügen nutzen - Bitte nur kurz zitieren. Außerdem bitte immer die vollständige Link-URL als Quelle angeben.
Original-Link: http://www.prnewswire.com/news-releases/...e-543506772.html
Resverlogix’ BETonMACE Phase 3 Trial Successfully Reaches its Targeted 250 MACE Events
https://web.tmxmoney.com/...newsid=8493065872644964&qm_symbol=RVX
CALGARY, Alberta, April 18, 2019 (GLOBE NEWSWIRE) -- Resverlogix Corp. (“Resverlogix” or the "Company") (TSX:RVX) today announces that BETonMACE, the Company’s event-based, phase 3 registration trial has successfully reached 250 projected major adverse cardiac events (MACE), strictly defined as cardiovascular death, non-fatal myocardial infarction and stroke, moving the trial towards completion. Successful data from this trial would enable Resverlogix to proceed towards the regulatory approval and commercialization of its lead drug, apabetalone.
“Resverlogix staff and stakeholders have worked diligently for the past 18 years to attain this extremely exciting goal,” said Donald McCaffrey, President and CEO of Resverlogix. “The trial’s extensive breakthrough clinical data will soon be available to Resverlogix. Successfully meeting the trial’s endpoints, the substantial data set and otherwise new findings would enable the Company to further solidify its apabetalone program as the world leader in epigenetic BET protein inhibition. Resverlogix is well positioned to advance therapies for several multi-factorial diseases with significant unmet need, and confirmation of our epigenetic technology would greatly change both the cost effectiveness and efficacy of future medications.”
“We are nearing completion of this important, potentially transformative study,” said Dr. Michael Sweeney, Senior Vice President, Clinical Development of Resverlogix. “At this time, we’d like to thank all study participants, the clinical sites and the many individuals who have supported the trial every step of the way. We look forward to completing the trial, and reporting the primary cardio/diabetes endpoint as well as other endpoints which include kidney and neurological function in the respective subsets of our patient group.”
Bis dahin dürfte es stetig weiter hoch gehen, da bisher alles auf einen Erfolg hindeutet.
Wenn Apabetalone zugelassen wird, sehen wir hier die Mrd-MK!
Läuft immer nach dem gleichen Muster....
https://www.resverlogix.com/upload/event/40/...corp-pres-march-18.pdf
Die Hoffnung liegt auf Apabetalone, ein protein inhibitor, der vielversprechende Anzeichen zur Behandlung von Herz-Kreislauf-Erkrankungen, Nierenerkrankungen und Diabetes II zeigt!
Allesamt Mrd-Märkte!
Die Phase III in Übersee als BETonMACE für Diabetes II wurde mit der letzten News quasi abgeschlossen und Ergebnisse kommen bald.
Apabetalone als BetonMACE wurde bereits in 18 Ländern (knapp 2.000 Patienten) getestet.
14 Länder haben bereits Freigabe für Phase III erteilt.
Von den diversen Patenten läuft das erste erst in 2027 aus.
Die Chinesen (Shenzen HepaLink Pharma) haben sich auch eingekauft in Resverlogix:
https://www.canadianinsider.com/node/...kersearch=RVX+%7C+Resverlogix
und sollen Apabetalone in China vertreiben (China: 4 MRD USD-Markt). Über die Lizenz rechnet man mit über 400Mio USD Einnahmen, plus über 100Mio USD aus Lizenzvertrag in Israel. Weitere Lizenzverträge sollen folgen.
Auch das letzte MD&A eine gute Lektüre:
https://www.resverlogix.com/upload/media_element/...nal-for-sedar.pdf
Die Cash-Position ist mit 6,5Mio USD recht dünn. Man wird wieder ein PP machen müssen. Mit den aktuellen positiven Entwicklungen dürfte das aber kein großes Problem werden....
Resverlogix Announces Publication on Apabetalone in High-Impact American Journal of Respiratory and Critical Care Medicine (AJRCCM
https://web.tmxmoney.com/...newsid=5608904128034676&qm_symbol=RVX
https://nebula.wsimg.com/...B2E3E&disposition=0&alloworigin=1
Auszug:
We have increased our valuation with the publication of topline data to be expected
within 2-3 months. We believe that Resverlogix remains gravely undervalued at the current
share price of CAD 4.05. We feel that the company’s potential for MACE reduction of greater
than 30% is possible and as a result suggest that the current total value should be of CAD 3.5-
4.6 billion, or CAD 17.50-23.07 per share. This represents a substantial upside from the current
share price.
Nur mal dass jedem klar ist, welchen Marktwert RVX einnehmen kann, wenn Apabetalone die erhofften Ergebnisse bringt - und danach sieht es bis dato ja aus :-)
Aktuell laufen Studien für folgende Einsatzgebiete:
Herz-Kreislauf-Erkrankungen
Diabetes
chronische Nierenerkrankungen
neurodegenerative Erkranungen (Demenz, Parkinson)
periphere Arterienerkrankungen
sog. "seltene Krankheiten" ("orphan disease")
Vor 2 Wochen lag die MK bei ca. 500 Mio ....
CALGARY, Alberta, June 12, 2019 (GLOBE NEWSWIRE) -- Resverlogix Corp. (“Resverlogix” or the "Company") (TSX:RVX) is pleased to announce today that all patients active in BETonMACE, the Company’s event-based, phase 3 registration trial, recently completed their last study visits on treatment. Final, follow-up safety visits are progressing and are expected to be completed by July 4th, 2019. Once safety visits have concluded for all patients, Resverlogix anticipates being in a position to provide an updated projected timeframe for top-line data readout.
The remaining steps are amongst those required to assure an orderly, safe and efficient culmination of BETonMACE:
•Three to four weeks after the last study visit for each patient, a follow-up safety visit will take place either in-person or via phone call to ensure that any safety issues continue to be monitored
•In parallel, the third-party adjudication committee will continue to adjudicate remaining and ongoing potential MACE events ◦Additional MACE (over 250) that accumulate during this period will be added to the results while not slowing down the trial’s move towards final database lock
•All patients who have discontinued the study will be contacted for an unscheduled follow-up visit or call to determine medical status
•Database Lock (DBL) will occur sometime after the last patient’s final visit and the last query is resolved
•Approximately two weeks after DBL, the primary endpoint and additional secondary and exploratory endpoints are expected to be announced
•Late-2019 and beyond – full outcomes, pre-specified endpoint data, safety results, and clinical implications are expected to be reported and published
Quelle:
https://web.tmxmoney.com/...newsid=7452337584543414&qm_symbol=RVX
Wird hier die nächsten Tage sicher sehr volatil....