Actinium Pharmaceuticals Inc. macht sich auf den Weg (Seite 14)
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ISIN: US00507W2061 · WKN: A2QA48 · Symbol: ATNM
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Moin Zusammen,
GAP Close oder weiter runter in den nächsten Tagen/Wochen?
Gruß
MM
GAP Close oder weiter runter in den nächsten Tagen/Wochen?
Gruß
MM
Antwort auf Beitrag Nr.: 55.887.802 von tancho am 05.10.17 17:09:10ja, das ist immer die eigene Entscheidung.
Woran machst du generell eine mögliche Kauf- oder Verkaufsentscheidung fest?
Aktuell läuft sie gerade in das Ende Juli "entstandene" GAP hinein.
Ob das nun Nachhaltig ist oder nicht, wird man sehen. Das weiß leider keiner.
Was steigt kann auch wieder fallen und umgekehrt.
Gruß
MM
Woran machst du generell eine mögliche Kauf- oder Verkaufsentscheidung fest?
Aktuell läuft sie gerade in das Ende Juli "entstandene" GAP hinein.
Ob das nun Nachhaltig ist oder nicht, wird man sehen. Das weiß leider keiner.
Was steigt kann auch wieder fallen und umgekehrt.
Gruß
MM
jetzt schon kaufen oder noch warten? wenn man dies immer vorher wüßte!
Actinium Pharmaceuticals Receives Clearance from Health Canada to Initiate Pivotal Phase 3 SIERRA Trial of Iomab-B
NEW YORK, May 10, 2017 (GLOBE NEWSWIRE) -- Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that the Company received clearance from Health Canada to initiate the pivotal Phase 3 SIERRA Trial of Iomab-B at Canadian based clinical trial sites. Iomab-B is Actinium’s lead asset that upon approval, is intended to prepare and condition patients for a bone marrow transplant (BMT), also referred to as a hematopoietic stem cell transplant (HSCT), which is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. The SIERRA trial is a 150-patient, randomized, multicenter pivotal study evaluating Iomab-B followed by an HSCT in patients with relapsed or refractory acute myeloid leukemia (AML) who are age 55 and above compared to physician’s choice of chemotherapy that patient’s in the control arm will receive.
According to the Canadian Blood and Marrow Transplant Group (CBMTG), there are approximately 15 centers in Canada that perform blood and marrow transplants who participate in the CBMTG’s registry. In CBMTG’s 2015/2016 annual report, it reported that there were 7,693 allogeneic transplants performed in Canada including 2,417 for patients with AML.
Dr. Mark Berger, Chief Medical Officer of Actinium said, “The clearance to initiate the SIERRA trial in Canada is an exciting milestone for Iomab-B as it offers us the opportunity to make Iomab-B available to more patients in need. We are expecting to open 15-20 clinical trial sites in the SIERRA trial and we are excited to begin to have participation from sites in Canada. The promise of Iomab-B is that it will enable a bone marrow transplant and long term survival for these patients that have few options for treatment.”
https://finance.yahoo.com/news/actinium-pharmaceuticals-rece…
NEW YORK, May 10, 2017 (GLOBE NEWSWIRE) -- Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that the Company received clearance from Health Canada to initiate the pivotal Phase 3 SIERRA Trial of Iomab-B at Canadian based clinical trial sites. Iomab-B is Actinium’s lead asset that upon approval, is intended to prepare and condition patients for a bone marrow transplant (BMT), also referred to as a hematopoietic stem cell transplant (HSCT), which is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. The SIERRA trial is a 150-patient, randomized, multicenter pivotal study evaluating Iomab-B followed by an HSCT in patients with relapsed or refractory acute myeloid leukemia (AML) who are age 55 and above compared to physician’s choice of chemotherapy that patient’s in the control arm will receive.
According to the Canadian Blood and Marrow Transplant Group (CBMTG), there are approximately 15 centers in Canada that perform blood and marrow transplants who participate in the CBMTG’s registry. In CBMTG’s 2015/2016 annual report, it reported that there were 7,693 allogeneic transplants performed in Canada including 2,417 for patients with AML.
Dr. Mark Berger, Chief Medical Officer of Actinium said, “The clearance to initiate the SIERRA trial in Canada is an exciting milestone for Iomab-B as it offers us the opportunity to make Iomab-B available to more patients in need. We are expecting to open 15-20 clinical trial sites in the SIERRA trial and we are excited to begin to have participation from sites in Canada. The promise of Iomab-B is that it will enable a bone marrow transplant and long term survival for these patients that have few options for treatment.”
https://finance.yahoo.com/news/actinium-pharmaceuticals-rece…
Trading Spotlight
Actinium Pharmaceuticals Appoints Pharmaceutical Industry Executive Ajit S. Shetty, Ph.D., to the Company’s Board of Directors
GlobeNewswire•March 28, 2017
- Proven leader with 36 years of experience with Johnson & Johnson in numerous executive capacities, most recently as Head of Enterprise Supply Chain
- Dr. Shetty was instrumental in establishing U.S. operations for Janssen, a Johnson & Johnson subsidiary, and contributing to the Janssen Group of companies’ growth from $1 billion in global sales to $8 billion
- Established track record of identifying pharmaceutical drug products including the in-licensing of Durogesic, a leading product for Johnson & Johnson that had $2 billion in global sales
http://finance.yahoo.com/news/actinium-pharmaceuticals-appoi…
GlobeNewswire•March 28, 2017
- Proven leader with 36 years of experience with Johnson & Johnson in numerous executive capacities, most recently as Head of Enterprise Supply Chain
- Dr. Shetty was instrumental in establishing U.S. operations for Janssen, a Johnson & Johnson subsidiary, and contributing to the Janssen Group of companies’ growth from $1 billion in global sales to $8 billion
- Established track record of identifying pharmaceutical drug products including the in-licensing of Durogesic, a leading product for Johnson & Johnson that had $2 billion in global sales
http://finance.yahoo.com/news/actinium-pharmaceuticals-appoi…
Actinium Announces Receipt of Positive Scientific Advice from the European Medicines Agency for Iomab-B
GlobeNewswire•March 21, 2017
- EMA guidance provides clear regulatory pathway for EU approval for Iomab-B
- Trial design, primary endpoint and planned statistical analysis from the Iomab-B U.S. pivotal Phase 3 SIERRA trial are acceptable as the basis for a Marketing Authorization Application
- EMA intent from Scientific Advice Program feedback is to increase the probability of positive outcomes and reduce risk of objections during evaluation of a Marketing Authorization Application
NEW YORK, March 21, 2017 (GLOBE NEWSWIRE) -- Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that the Company has received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to the EU approval pathway for Iomab-B. In its correspondence to Actinium, the EMA commented that the trial design, primary endpoint and planned statistical analysis of the U.S. pivotal Phase 3 SIERRA (Study of Iomab-B in Relapsed or Refractory AML) trial are acceptable and can serve as the basis for submission of a Marketing Authorization Application. In addition, the EMA commented that it does not anticipate the need for further standalone preclinical toxicology or safety studies. The EMA requested supporting data and information that is already being collected as part of the U.S. pivotal Phase 3 SIERRA trial. The SIERRA trial is a 150 patient, randomized controlled study of Iomab-B that is currently enrolling patients in the U.S. Upon approval, Iomab-B is intended to be an induction and conditioning agent prior to a bone marrow transplant (BMT), often referred to as a hematopoietic stem cell transplant (HSCT) with an initial indication in patients with relapsed or refractory acute myeloid leukemia (AML) who are age 55 and above.
“We thank the EMA for their assistance throughout the Scientific Advice process and for this helpful feedback.“ said Sandesh Seth, Executive Chairman of Actinium. “We are excited that the EMA finds the design, endpoints and statistical analysis of the Iomab-B SIERRA trial acceptable.
Their opinion is an extremely favorable outcome as this will potentially reduce the time and cost to gain marketing authorization in the EU, which is a larger addressable market than the U.S. in terms of number of patients and transplant procedures. With orphan designation for Iomab-B in the EU and now with this positive Scientific Advice, a clear regulatory pathway, we are well positioned to maximize the value of Iomab-B by working strategically to make this potentially curative therapy available to patients in the EU in addition to our efforts in the U.S.”
The EMA provides scientific advice to companies regarding the appropriate studies for the development of a medicine. The goal of scientific advice is to facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefits of patients. Scientific Advice helps companies make sure they perform the appropriate tests and studies, so that no major objections regarding the design of tests are likely to be raised during the evaluation of a marketing authorization application. The EMA created this program to increase the probability of positive outcomes and to reduce the risk of objections during the evaluation of a market-authorization application. Following the EMA’s advice increases the probability of a positive outcome.
http://finance.yahoo.com/news/actinium-announces-receipt-pos…
GlobeNewswire•March 21, 2017
- EMA guidance provides clear regulatory pathway for EU approval for Iomab-B
- Trial design, primary endpoint and planned statistical analysis from the Iomab-B U.S. pivotal Phase 3 SIERRA trial are acceptable as the basis for a Marketing Authorization Application
- EMA intent from Scientific Advice Program feedback is to increase the probability of positive outcomes and reduce risk of objections during evaluation of a Marketing Authorization Application
NEW YORK, March 21, 2017 (GLOBE NEWSWIRE) -- Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that the Company has received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to the EU approval pathway for Iomab-B. In its correspondence to Actinium, the EMA commented that the trial design, primary endpoint and planned statistical analysis of the U.S. pivotal Phase 3 SIERRA (Study of Iomab-B in Relapsed or Refractory AML) trial are acceptable and can serve as the basis for submission of a Marketing Authorization Application. In addition, the EMA commented that it does not anticipate the need for further standalone preclinical toxicology or safety studies. The EMA requested supporting data and information that is already being collected as part of the U.S. pivotal Phase 3 SIERRA trial. The SIERRA trial is a 150 patient, randomized controlled study of Iomab-B that is currently enrolling patients in the U.S. Upon approval, Iomab-B is intended to be an induction and conditioning agent prior to a bone marrow transplant (BMT), often referred to as a hematopoietic stem cell transplant (HSCT) with an initial indication in patients with relapsed or refractory acute myeloid leukemia (AML) who are age 55 and above.
“We thank the EMA for their assistance throughout the Scientific Advice process and for this helpful feedback.“ said Sandesh Seth, Executive Chairman of Actinium. “We are excited that the EMA finds the design, endpoints and statistical analysis of the Iomab-B SIERRA trial acceptable.
Their opinion is an extremely favorable outcome as this will potentially reduce the time and cost to gain marketing authorization in the EU, which is a larger addressable market than the U.S. in terms of number of patients and transplant procedures. With orphan designation for Iomab-B in the EU and now with this positive Scientific Advice, a clear regulatory pathway, we are well positioned to maximize the value of Iomab-B by working strategically to make this potentially curative therapy available to patients in the EU in addition to our efforts in the U.S.”
The EMA provides scientific advice to companies regarding the appropriate studies for the development of a medicine. The goal of scientific advice is to facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefits of patients. Scientific Advice helps companies make sure they perform the appropriate tests and studies, so that no major objections regarding the design of tests are likely to be raised during the evaluation of a marketing authorization application. The EMA created this program to increase the probability of positive outcomes and to reduce the risk of objections during the evaluation of a market-authorization application. Following the EMA’s advice increases the probability of a positive outcome.
http://finance.yahoo.com/news/actinium-announces-receipt-pos…
bin auch raus ....tja man kann nich timmer gewinnen ....
Das war's dann wohl hier. Nach der Nummer werden die Shorts das Ding runterprügeln. Bald unter 1 Dollar!
Actinium Pharma (ATNM) Initiates Phase 2 Trial of Actimab-A in AML
http://www.streetinsider.com/Corporate+News//Actinium+Pharma…
http://www.streetinsider.com/Corporate+News//Actinium+Pharma…
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