BLU.TO (Mkap $22 M) Big Rare Disease Drug in Phase3 = 500%++ Potential (Seite 32)
eröffnet am 29.01.14 15:27:44 von
neuester Beitrag 18.04.23 18:43:43 von
neuester Beitrag 18.04.23 18:43:43 von
Beiträge: 381
ID: 1.190.903
ID: 1.190.903
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Gesamt: 86.322
Gesamt: 86.322
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ISIN: CA07987C2040 · WKN: A2PQKK
13,550
EUR
+0,74 %
+0,100 EUR
Letzter Kurs 29.06.23 Lang & Schwarz
Neuigkeiten
16.06.23 · Business Wire (engl.)  |
16.05.23 · Business Wire (engl.) |
12.05.23 · Business Wire (engl.) |
27.04.23 · Business Wire (engl.) |
Werte aus der Branche Biotechnologie
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 53,50 | +98,15 | |
| 1,3500 | +29,82 | |
| 4,5700 | +24,18 | |
| 1,8300 | +23,65 | |
| 0,8820 | +22,50 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 5,4000 | -15,23 | |
| 0,7008 | -15,56 | |
| 0,7603 | -15,56 | |
| 4,9000 | -31,94 | |
| 9,7600 | -32,74 |
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nur so am Rande
hat einer von euch die IGI Laboratories (NYSE: MKT) auf dem Schirm?
Schönes up heute und der Jahres-Chart ist beeindruckend, hatte mich da noch nicht getraut, aber nun ist ne kleine Posi drin.
hat einer von euch die IGI Laboratories (NYSE: MKT) auf dem Schirm?
Schönes up heute und der Jahres-Chart ist beeindruckend, hatte mich da noch nicht getraut, aber nun ist ne kleine Posi drin.
Beobachte das nun schon seit 2 Monaten, diese Kurssprünge sind echt phenomenal und kommen immer aus dem Nichts.
Wäre ja schön wenn man sich da schon in Stellung bringt für 2016 und die P3 Ergebnisse.
Wäre ja schön wenn man sich da schon in Stellung bringt für 2016 und die P3 Ergebnisse.
Wow, jetzt gehts aber ab zum Handelsschluss, noch mal ein Kauf von 50K Stück
zu 1,65 CAD.
Sieht aus, als ob da in Kürze News anstehen.
zu 1,65 CAD.
Sieht aus, als ob da in Kürze News anstehen.
Antwort auf Beitrag Nr.: 47.857.277 von DasTier666 am 23.09.14 21:15:44Ja, nun bin ich auch im grünen Bereich, ganz schöner Kursschub heute von
1,20 auf 1,50 CAD. Das der Wert extrem markteng ist, sieht man mit wie wenig
Aktien man hier solche Kurssprünge auslösen kann. Wenn hier mal richtig großes
Kaufinteresse reinkommt, möchte ich nicht wissen wo dann der Kurs steht, na mir
solls recht sein.
1,20 auf 1,50 CAD. Das der Wert extrem markteng ist, sieht man mit wie wenig
Aktien man hier solche Kurssprünge auslösen kann. Wenn hier mal richtig großes
Kaufinteresse reinkommt, möchte ich nicht wissen wo dann der Kurs steht, na mir
solls recht sein.
Antwort auf Beitrag Nr.: 47.832.692 von olli60 am 20.09.14 15:24:05gern geschehen
1,43, nun wird's doch bestimmt langsam grün bei dir
1,43, nun wird's doch bestimmt langsam grün bei dir
Trading Spotlight
Antwort auf Beitrag Nr.: 47.817.086 von DasTier666 am 18.09.14 18:21:54Danke für das reinstellen der letzten beiden Beiträge, bzw. Artikel zu BELLUS.
Die Berichte sind sehr informativ und zeigen das BELLUS auf dem richtigen Weg
ist, auch wenn es mit Ergebnissen aus der Phase 3 Studie noch eine ganze
Weile dauern wird.
Übrigens habe mir vergangenen Donnerstag noch eine zweite Position zugelegt,
bin damit zwar im Gesamtinvest bei BELLUS immer noch leicht im minus aber
hoffe doch, dass es demnächst wieder nach oben geht. Die letzten beiden Tage
sahen ja schon mal ganz gut aus.
Wünsche allen ein schönes Wochenende.
Die Berichte sind sehr informativ und zeigen das BELLUS auf dem richtigen Weg
ist, auch wenn es mit Ergebnissen aus der Phase 3 Studie noch eine ganze
Weile dauern wird.
Übrigens habe mir vergangenen Donnerstag noch eine zweite Position zugelegt,
bin damit zwar im Gesamtinvest bei BELLUS immer noch leicht im minus aber
hoffe doch, dass es demnächst wieder nach oben geht. Die letzten beiden Tage
sahen ja schon mal ganz gut aus.
Wünsche allen ein schönes Wochenende.
TRANSPARENCY LIFE SCIENCES TO CONDUCT SARCOIDOSIS TRIAL FOR AUVEN THERAPEUTICS’ KIACTATM USING CROWDSOURCING AND TELEMONITORING
—Use of Crowdsourced Clinical Trial Protocols and Telemonitoring for Remote Patient Data, Collection Is Potential Game-Changer for Orphan Diseases
New York, NY — September, 19, 2014 — Transparency Life Sciences, LLC (TLS), the world’s first clinical-stage drug development company based on open innovation, today announced that it is applying its expertise in crowdsourcing and digital telemonitoring technology to conduct a clinical trial of Auven Therapeutics’ KiactaTM in patients with sarcoidosis, a rare systemic inflammatory disease. Kiacta is an orally bioavailable small molecule that is in a final Phase III confirmatory trial for the treatment of AA amyloidosis.
TLS aims to revolutionize clinical drug development in three ways: by soliciting crowdsourced expertise to improve the design of clinical trials, by replacing patient site visits with telemonitoring and other remote digital technologies, and by operating with full data transparency. The goal is more patient-centric, transparent and dramatically less costly clinical development.
“Transparency’s focus on crowdsourced design and home-based data collection promises to make clinical trials for orphan indications far more feasible, by aligning clinical endpoints with clinical practice while minimizing geographical barriers,” noted Marc Foster, co-founder and COO of Transparency Life Sciences. “Kiacta has shown promising efficacy in the systemic inflammatory disease AA amyloidosis, and we are pleased to have the opportunity to assess it as a potential therapy for sarcoidosis, an orphan indication that has few current treatment options.”
TLS is developing the clinical protocol for the Kiacta study using its Protocol BuilderTM, a proprietary online tool that invites structured input from researchers, physicians and patients to design clinical trials that have greater relevance to patient experience and clinical practice. TLS is also soliciting input from sarcoidosis patient and physician communities through collaborations with the Foundation for Sarcoidosis Research and Inspire, an online patient engagement platform.
The trial will minimize the need for patient site visits by primarily relying on remote data collection using a variety of telemonitoring tools. TLS is partnering with AMC Health, a comprehensive provider of telemedicine services, to help conduct the study.
Kiacta is in Phase lll development for the treatment of AA amyloidosis, an orphan indication that often leads to kidney dialysis and death. Kiacta was originally developed by BELLUS Health. Auven Therapeutics acquired worldwide rights to Kiacta in 2010 and is responsible for designing, financing and conducting the Kiacta development program. Preclinical research demonstrates that Kiacta may interrupt a critical pathway in the development of sarcoidosis.
About Sarcoidosis Sarcoidosis is a systemic disease involving abnormal collections of inflammatory cells (granulomas) that form in multiple organs. The granulomas are most often located in the lungs, but any organ can be affected. Sarcoidosis is likely caused by a prolonged immune reaction to an infection or other trigger in susceptible individuals. In many cases it clears up without medical intervention, but sarcoidosis can go on to affect the patient adversely over the long-term, and can become disabling or life-threatening. Current treatments such as non-steroidal anti-inflammatory drugs and corticosteroids can help relieve symptoms, but do not alter the course of the disease.
About Transparency Life Sciences Transparency Life Sciences (TLS) is the world’s first clinical-stage drug development company based on open innovation. TLS acquires promising new chemical entities and repurposed compounds that address
unmet medical needs and tests them in clinical trials that leverage crowdsourcing methods, advances in telemedicine and full data transparency. The company expects this innovative approach to result in significantly reduced costs and improved data quality. For more information, visit: www.transparencyls.com.
http://transparencyls.com/files/PDF/TLS_Kiacta_091814_Final.…
—Use of Crowdsourced Clinical Trial Protocols and Telemonitoring for Remote Patient Data, Collection Is Potential Game-Changer for Orphan Diseases
New York, NY — September, 19, 2014 — Transparency Life Sciences, LLC (TLS), the world’s first clinical-stage drug development company based on open innovation, today announced that it is applying its expertise in crowdsourcing and digital telemonitoring technology to conduct a clinical trial of Auven Therapeutics’ KiactaTM in patients with sarcoidosis, a rare systemic inflammatory disease. Kiacta is an orally bioavailable small molecule that is in a final Phase III confirmatory trial for the treatment of AA amyloidosis.
TLS aims to revolutionize clinical drug development in three ways: by soliciting crowdsourced expertise to improve the design of clinical trials, by replacing patient site visits with telemonitoring and other remote digital technologies, and by operating with full data transparency. The goal is more patient-centric, transparent and dramatically less costly clinical development.
“Transparency’s focus on crowdsourced design and home-based data collection promises to make clinical trials for orphan indications far more feasible, by aligning clinical endpoints with clinical practice while minimizing geographical barriers,” noted Marc Foster, co-founder and COO of Transparency Life Sciences. “Kiacta has shown promising efficacy in the systemic inflammatory disease AA amyloidosis, and we are pleased to have the opportunity to assess it as a potential therapy for sarcoidosis, an orphan indication that has few current treatment options.”
TLS is developing the clinical protocol for the Kiacta study using its Protocol BuilderTM, a proprietary online tool that invites structured input from researchers, physicians and patients to design clinical trials that have greater relevance to patient experience and clinical practice. TLS is also soliciting input from sarcoidosis patient and physician communities through collaborations with the Foundation for Sarcoidosis Research and Inspire, an online patient engagement platform.
The trial will minimize the need for patient site visits by primarily relying on remote data collection using a variety of telemonitoring tools. TLS is partnering with AMC Health, a comprehensive provider of telemedicine services, to help conduct the study.
Kiacta is in Phase lll development for the treatment of AA amyloidosis, an orphan indication that often leads to kidney dialysis and death. Kiacta was originally developed by BELLUS Health. Auven Therapeutics acquired worldwide rights to Kiacta in 2010 and is responsible for designing, financing and conducting the Kiacta development program. Preclinical research demonstrates that Kiacta may interrupt a critical pathway in the development of sarcoidosis.
About Sarcoidosis Sarcoidosis is a systemic disease involving abnormal collections of inflammatory cells (granulomas) that form in multiple organs. The granulomas are most often located in the lungs, but any organ can be affected. Sarcoidosis is likely caused by a prolonged immune reaction to an infection or other trigger in susceptible individuals. In many cases it clears up without medical intervention, but sarcoidosis can go on to affect the patient adversely over the long-term, and can become disabling or life-threatening. Current treatments such as non-steroidal anti-inflammatory drugs and corticosteroids can help relieve symptoms, but do not alter the course of the disease.
About Transparency Life Sciences Transparency Life Sciences (TLS) is the world’s first clinical-stage drug development company based on open innovation. TLS acquires promising new chemical entities and repurposed compounds that address
unmet medical needs and tests them in clinical trials that leverage crowdsourcing methods, advances in telemedicine and full data transparency. The company expects this innovative approach to result in significantly reduced costs and improved data quality. For more information, visit: www.transparencyls.com.
http://transparencyls.com/files/PDF/TLS_Kiacta_091814_Final.…
Roadmap Capital’s Hugh Cleland and Stephen Ireland: Due Diligence Rules in Biotech Investment
By The Life Sciences Report, on September 17th, 2014
...HC: Tekmira wasn’t the only one. BELLUS Health Inc. (BLU:TSX; BLUSF:OTCPK) is one where we have a large position, with an average cost of around CA$0.50/share, but we still haven’t sold any even though we have about a triple, with BELLUS at about CA$1.50 today. The binary events at BELLUS are still almost two years out, so that is our risk point. Its fully diluted market cap is still under CA$100M million (CA$100M), so we think there’s still an enormous valuation gap between BELLUS and comparables (comps) in the orphan drug space. There definitely will be a point where we take our invested capital off the table, but we’re not there yet.
TLSR: What do the comps to BELLUS look like?
HC: Comparable orphan drug companies (meaning companies at a similar stage of development, with similar peak sales estimates) trade between $500M and more than $1 billion ($1B). In the case of BELLUS, with the binary event about two years out, there is still plenty of time to fill that gap. If BELLUS fills the valuation gap, as we think it will, it will end up trading somewhere in the $4-8/share range. If the biotech space gets as heated as we think it will, BELLUS could very well trade above $10/share....
...HC: Let’s go back to BELLUS, which was one of 10 companies on the healthcare side that presented to our advisory board in May 2013. The company has really come out on top. Stephen did three months of due diligence on the name before he felt comfortable pounding the table for it and having it added to the portfolio.
Bellus is also interesting because we never felt the need to see management changes. We feel very comfortable with both the management and the board, and we think the BELLUS team has done a great job of designing the company’s clinical trials this time around.
The company is in a fully funded Phase 3 program in an orphan drug indication called AA amyloidosis, which is a lethal disease affecting 50,000 people in the U.S., Europe and Japan. The drug candidate is Kiacta (eprodisate disodium), and peak sales could reach close to $1B if the drug makes it through to market. As I said, there are no binary events for 18–24 months.
TLSR: Stephen, BELLUS’ partner in Kiacta is Auven Therapeutics, which is funding this confirmatory Phase 3 trial in AA amyloidosis. The company had previously done a Phase 2/3 (Phase 2b) trial, where the results were reportedly mixed. The FDA asked for this current 230-patient, double-blind and randomized Phase 3 trial, correct?
SI: I wouldn’t say the results of that first pivotal trial were mixed. It was that the results didn’t reach the level of statistical significance that would have allowed the FDA to use that single study for approval. The agency usually requires two pivotal studies—it’s actually unusual for the FDA to allow a single study for approval. I think the only reason that a single study was even considered was because this is an orphan indication.
Having looked at the results myself, I think the data were positive. There were clear trends toward improvement in the Kiacta-treated patients. Also, in the open-label, follow-up study, there was a significant reduction in time to end-stage renal failure or dialysis. This, to me, is the hard endpoint that you want for a drug like this. If you can treat a patient whose kidney function would otherwise deteriorate to the point where he or she would require a transplant—or would die—and delay the time it takes to get to that event, that’s a robust measure of efficacy.
I think the data were robust, and BELLUS has made adjustments in its current confirmatory Phase 3 study to increase the chance of being successful. In conjunction with the FDA, the company has designed a protocol with endpoints the agency has agreed to, focusing on functional kidney deterioration. It’s a composite endpoint, so there are a number of things in it, including glomerular filtration rate measured by kidney biomarkers, creatinine clearance and serum creatinine, end-stage renal disease and dialysis. The primary endpoint is tied to events of kidney function deterioration, and the time to those events is measured. This study will run until the company gets 120 events in the 230 patients enrolled. Based on the Phase 2/3 study, I think the confirmatory Phase 3 study has a very good probability of showing positive results.
TLSR: Stephen, the final data collection date for this Phase 3 trial is September 2016, but could events cause data to be reported earlier?
SI: Based on what the company has said publicly, it is on track for the study to be complete sometime in the May–June 2016 time frame. It will take three or four months to unlock the database and have the data ready for presentation. I anticipate the data will read out sometime late in Q3/16.
http://jutiagroup.com/20140917-roadmap-capitals-hugh-cleland…
By The Life Sciences Report, on September 17th, 2014
...HC: Tekmira wasn’t the only one. BELLUS Health Inc. (BLU:TSX; BLUSF:OTCPK) is one where we have a large position, with an average cost of around CA$0.50/share, but we still haven’t sold any even though we have about a triple, with BELLUS at about CA$1.50 today. The binary events at BELLUS are still almost two years out, so that is our risk point. Its fully diluted market cap is still under CA$100M million (CA$100M), so we think there’s still an enormous valuation gap between BELLUS and comparables (comps) in the orphan drug space. There definitely will be a point where we take our invested capital off the table, but we’re not there yet.
TLSR: What do the comps to BELLUS look like?
HC: Comparable orphan drug companies (meaning companies at a similar stage of development, with similar peak sales estimates) trade between $500M and more than $1 billion ($1B). In the case of BELLUS, with the binary event about two years out, there is still plenty of time to fill that gap. If BELLUS fills the valuation gap, as we think it will, it will end up trading somewhere in the $4-8/share range. If the biotech space gets as heated as we think it will, BELLUS could very well trade above $10/share....
...HC: Let’s go back to BELLUS, which was one of 10 companies on the healthcare side that presented to our advisory board in May 2013. The company has really come out on top. Stephen did three months of due diligence on the name before he felt comfortable pounding the table for it and having it added to the portfolio.
Bellus is also interesting because we never felt the need to see management changes. We feel very comfortable with both the management and the board, and we think the BELLUS team has done a great job of designing the company’s clinical trials this time around.
The company is in a fully funded Phase 3 program in an orphan drug indication called AA amyloidosis, which is a lethal disease affecting 50,000 people in the U.S., Europe and Japan. The drug candidate is Kiacta (eprodisate disodium), and peak sales could reach close to $1B if the drug makes it through to market. As I said, there are no binary events for 18–24 months.
TLSR: Stephen, BELLUS’ partner in Kiacta is Auven Therapeutics, which is funding this confirmatory Phase 3 trial in AA amyloidosis. The company had previously done a Phase 2/3 (Phase 2b) trial, where the results were reportedly mixed. The FDA asked for this current 230-patient, double-blind and randomized Phase 3 trial, correct?
SI: I wouldn’t say the results of that first pivotal trial were mixed. It was that the results didn’t reach the level of statistical significance that would have allowed the FDA to use that single study for approval. The agency usually requires two pivotal studies—it’s actually unusual for the FDA to allow a single study for approval. I think the only reason that a single study was even considered was because this is an orphan indication.
Having looked at the results myself, I think the data were positive. There were clear trends toward improvement in the Kiacta-treated patients. Also, in the open-label, follow-up study, there was a significant reduction in time to end-stage renal failure or dialysis. This, to me, is the hard endpoint that you want for a drug like this. If you can treat a patient whose kidney function would otherwise deteriorate to the point where he or she would require a transplant—or would die—and delay the time it takes to get to that event, that’s a robust measure of efficacy.
I think the data were robust, and BELLUS has made adjustments in its current confirmatory Phase 3 study to increase the chance of being successful. In conjunction with the FDA, the company has designed a protocol with endpoints the agency has agreed to, focusing on functional kidney deterioration. It’s a composite endpoint, so there are a number of things in it, including glomerular filtration rate measured by kidney biomarkers, creatinine clearance and serum creatinine, end-stage renal disease and dialysis. The primary endpoint is tied to events of kidney function deterioration, and the time to those events is measured. This study will run until the company gets 120 events in the 230 patients enrolled. Based on the Phase 2/3 study, I think the confirmatory Phase 3 study has a very good probability of showing positive results.
TLSR: Stephen, the final data collection date for this Phase 3 trial is September 2016, but could events cause data to be reported earlier?
SI: Based on what the company has said publicly, it is on track for the study to be complete sometime in the May–June 2016 time frame. It will take three or four months to unlock the database and have the data ready for presentation. I anticipate the data will read out sometime late in Q3/16.
http://jutiagroup.com/20140917-roadmap-capitals-hugh-cleland…
Was sind das eigentlich für Kurssprünge?
Gibt es so wenige freie Aktien?
Hat jemand eine Erkärung dafür?
Gibt es so wenige freie Aktien?
Hat jemand eine Erkärung dafür?
Der heutige Tag könnte spannend werden, haben gestern genau bei 1,26 CAD geschossen
und genau dort verläuft derzeit die 50-Tageslinie. Sollten wir heute von dort nach
oben abprallen wäre das ein gutes Zeichen, sollten wir drunter fallen verläuft die
nächste Unterstützungslinie erst wieder bei 1,05 CAD und dann eine relativ starke
bei derzeit 0,90 CAD. Aber hoffen wir mal, dass die derzeitige Unterstützung bei
1,25-1,26 CAD hält.
http://www.stockta.com/cgi-bin/analysis.pl?symb=BLU.C&cobran…
und genau dort verläuft derzeit die 50-Tageslinie. Sollten wir heute von dort nach
oben abprallen wäre das ein gutes Zeichen, sollten wir drunter fallen verläuft die
nächste Unterstützungslinie erst wieder bei 1,05 CAD und dann eine relativ starke
bei derzeit 0,90 CAD. Aber hoffen wir mal, dass die derzeitige Unterstützung bei
1,25-1,26 CAD hält.
http://www.stockta.com/cgi-bin/analysis.pl?symb=BLU.C&cobran…
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