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I have no clue that's why I'm asking you my friend.. still have my 10,000 shares regardless ??
What do you think
will happen?
Midas..if that happens would the stock price go up?
I think both Gamida Cell and
InsighTec will go public in
the foreseeable future!
Midas..long time no see my friend..when you think the stock price will move up again? Also do you think Insightec will go public?
INSIGHTEC Receives FDA Approval for Exablate Neuro for 1.5T MRI in the Treatment of Essential Tremor
HAIFA, Israel, May 9, 2017 /PRNewswire/ --
INSIGHTEC, the leader in MR-guided Focused Ultrasound (MRgFUS), announced today that the FDA has approved its Exablate Neuro (Model 4000) system for use with 1.5T MRI in the non-invasive treatment of essential tremor (ET) in patients who have not responded to medication.
Exablate Neuro uses focused ultrasound waves to target and ablate the Vim nucleus of the thalamus with no surgical incisions or implants. The treatment is done under MRI guidance for real-time treatment monitoring. In July 2016, INSIGHTEC received FDA approval for the Exablate Neuro for use with 3.0T MRI systems. This approval for a new MR head coil significantly opens new potential markets for INSIGHTEC'S Exablate Neuro as 1.5T systems are the most common MRI systems in use today.
Essential tremor is the most common movement disorder, affecting more than 42 million people worldwide. For patients suffering from essential tremor, performing everyday tasks presents a challenge and impacts their quality of life.
"Being able to bring MR-guided focused ultrasound to hospitals that have 1.5T MRIs will enable more essential tremor patients to have access to this non-invasive treatment option using INSIGHTEC's ground-breaking technology," stated Maurice R. Ferré MD, INSIGHTEC Chief Executive Officer and Chairman of the Board.
To read more about the Exablate Neuro, please visit: http://www.insightec.com/us/clinical/neurosurgery
About INSIGHTEC
INSIGHTEC is the world leader and innovator of MR-guided Focused Ultrasound (MRgFUS). The company's non-invasive therapy platforms, Exablate and Exablate Neuro, are proven technology based on sound clinical evidence for treating essential tremor, painful bone metastases and uterine fibroids. The company is dedicated to improving patient lives by collaborating with physicians, medical institutions, academic researchers and regulatory bodies around the world. For more information, please visit: http://www.insightec.com .
Media Contact:
Michelle Barry
Red Lorry Yellow Lorry for INSIGHTEC
insightec@rlyl.com
+1(617)237-0922
SOURCE INSIGHTEC
Elbit Imaging puts two Bucharest hotels on the market
5th May 2017 | Ákos Budai
NASDAQ and the Tel Aviv Stock Exchange-listed Elbit Imaging has put two of its Bucharest hotels on the market. The company is hoping to finalise the sale of the five-star Radisson Blu and the four-star Park Inn by the end of the year.
Radisson Blu is the biggest five-star hotel in Romania. It contains 424 rooms and 63 apartments. The Park Inn offers 210 rooms and 66 apartments.
The London office of real estate consultancy JLL will oversee the sale of Radisson Blu.
Alzheimer's trial to study opening blood-brain
barrier with focused ultrasound
May 03, 2017
by Thomas Dworetzky , Contributing Reporter
https://www.dotmed.com/news/story/37054
Canadian scientists have begun clinical trials using focused ultrasound to breach the blood-brain barrier temporarily in patients with Alzheimer’s disease.
A safe, non-invasive way to open this barrier could prove key to “properly testing” future drug treatments for Alzheimer's, according to Dr. Sandra Black, who holds the Brill Chair of Neurology at Sunnybrook Health Sciences Centre and University of Toronto, and is a co-principal investigator of the new trial.
“By opening up the [blood-brain barrier] using low frequency ultrasound, we’ve taken a small but important step that opens up a whole new vista of possibilities,” she said in a Sunnybrook statement. She explained that “the hope is there may be a way to eventually open up multiple little windows, in a gentle way, in order to get large molecules like drugs and even stem cells into the brain. But we need to take it one step at a time.”
The trial is studying the technique in patients with early-to-moderate disease. The hope is that the results will help “plan future clinical trials to establish what role focused ultrasound may play, whether alone or in conjunction with medical treatments, in the management of Alzheimer’s,” the study's principal investigator, neurosurgeon Dr. Nir Lipsman, noted in a Focused Ultrasound Foundation statement.
The trial makes use of INSIGHTEC’s Exablate Neuro low-frequency platform.
The device will deliver focused ultrasound to “a small area of the right frontal lobe,” according to the foundation report. Researchers will then examine images to determine if the blood-brain barrier was opened.
In phase two of the trial, at one month, a similar approach will be taken targeting a larger frontal lobe area, and again images will be studied to see if the barrier was temporarily opened.
Sunnybrook researchers were first successful opening the barrier in this fashion in late 2015. Nearly 20 years of research by Dr. Kullervo Hynynen, Director of Physical Sciences at Sunnybrook Research Institute, in conjunction with INSIGHTEC, led to the technology's development and its present clinically-ready state.
“Now that our focused ultrasound technology has successfully disrupted the blood-brain barrier, our collaborative efforts can be focused on delivering clinical solutions to help patients suffering from various brain diseases,” noted INSIGHTEC General Manager Eyal Zadicario.
The possibility of temporarily breaching the barrier opens the door to a host of potential treatment modalities able to deliver high doses of drugs to the brain. Calling brain applications a “research priority” and a “new frontier” for the Focused Ultrasound Foundation, its Chairman Dr. Neal Kassell, stressed that “these initial findings represent a small but critical step that could lead to a game-changing approach to treating one of the most challenging and least understood brain diseases.”
Treatment with focused ultrasound made news in December, 2016, when the Imperial College Healthcare NHS Trust became the first in the U.K. to treat essential tremor with the technology.
"This breakthrough allows us now to operate on these patients without the significant risks that inserting an electrode 15 cm deep into the brain entails," Dr. Dipankar Nandi, consultant neurosurgeon, said at the time.
In an interview in the April issue of Heathcare Business News magazine, Dr. Maurice R. Ferré, INSIGHTEC's CEO and chairman, explained why he is so optimistic about the technology's potential.
“Focused ultrasound shows promise in becoming a new era for the way we look at surgical procedures and patient care. All of us, and the health care system at large, would opt for undergoing a surgical procedure that is incisionless, without lengthy hospital stays or succumbing ourselves to the risk of infection. We are quickly beginning to realize the enormous potential of focused ultrasound and we are constantly researching treatments for a variety of clinical indications that many thought were impossible to treat.”
Elbit Imaging Announces Suspension of Plaza Centers' Ordinary Shares From Trading on the London Stock Exchange and Listing on the Official List, Trading on the Warsaw Stock Exchange and the Tel Aviv Stock Exchange and Suspension of Trading of Series A and Series B Notes on Tel Aviv Stock Exchange
TEL AVIV, ISRAEL / ACCESSWIRE / May 3, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE, NASDAQ: EMITF) announced today, that Plaza Centers N.V. ("Plaza") (PLAZ.L), an indirect subsidiary (45%) of the Company, at Plaza's request and pending the release of publication of Plaza's financial results for the year ended 31 December 2016 (the "2016 Accounts"), Plaza's ordinary shares have been suspended, with effect from 7.30 a.m. (London time) this morning from trading on the London Stock Exchange's main market for listed securities and being listed on the Official List of the Financial Conduct Authority. As a result of the aforementioned suspension Plaza has requested suspension of ordinary shares from trading on the Warsaw Stock Exchange as of 2 May 2017. As a further result of the aforementioned suspensions, Plaza's ordinary shares and its Series A Notes and Series B Notes (together, the "Notes") have been suspended from trading on the Tel Aviv Stock Exchange. The delay to the publication of Plaza's 2016 Accounts follows discussions between Plaza and its auditors with respect to the auditor's opinion regarding certain issues relating to old agreements entered prior to Plaza's and the Company's debt restructurings (the Company is also a party to one of these agreements). Elbit will update upon any development with respect to the trading of Plaza's shares and Notes, following publication of the Plaza's 2016 Accounts.
About Elbit Imaging Ltd.
Elbit Imaging Ltd. operates in the following principal fields of business: (i) Commercial centers - initiation, construction, and sale of commercial centers and other mixed-use property projects, predominantly in the retail sector, located in Central and Eastern Europe. In certain circumstances and depending on market conditions, the Group operates and manages commercial centers prior to their sale. (ii) Hotel - operation and management of the Radisson hotel complex in Bucharest, Romania. (iii) Medical industries and devices - (a) research and development, production and marketing of magnetic resonance imaging guided focused ultrasound treatment equipment, and (b) development of stem cell population expansion technologies and stem cell therapy products for transplantation and regenerative medicine. (iv) Plots in India - plots designated for sale initially designated to residential projects.
Elbit Imaging Announces Update Regarding Class Action
TEL AVIV, ISRAEL / ACCESSWIRE / May 2, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE, NASDAQ: EMITF) announced today in further to its announcement dated April 6, 2016, regarding class action #1318/99 (Gadish v. Elscint et. al.) (the " Settlement"), that the court did not approve the settlement agreement with the Plaintiffs and set dates for the continuous of the legal proceedings.
The Company is considering its legal action options with respect to the abovemention court resolution, including appealing to the Supreme Court.
For further information with regards to the class action, please see Note 14B. (1) of our Annual Consolidated Financial Statements as of December 31, 2015 filed as Exhibit 99.1 to our Report on Form 8-K filed with the SEC on March 31, 2016.
Elbit Imaging Ltd. Announces FDA Approval Extension of Insightec's Exablate Neuro for Treatment of Essential Tremor
TEL AVIV, ISREAL / ACCESSWIRE / April 24, 2017 / Elbit Imaging Ltd. (EMITF.TA) (EMITF) ("Elbit" or the "Company") announced today, in furtherance to the announcements dated on October 22, 2015 and July 12, 2016, that it was informed by INSIGHTEC Ltd. ("INSIGHTEC"), that the FDA has extended its approval of Exablate Neuro system for a non-invasive treatment of essential tremor in patients who have not responded to medication and now it's including the usage on 1.5 Tesla MRI systems (the FDA approval which was announced on July 12, 2016, was given for the usage of the Exablate Neuro on 3 Tesla magnet strength MRI systems). The above-mentioned extension is expected to expend the product's markets of which Exablate Neuro is applicable for.
Exablate Neuro uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions or implants. The treatment is done under MRI guidance for real time treatment monitoring.
Essential tremor is the most common movement disorder, affecting more than 5 million people in the United States, and millions more worldwide. Hand tremor is the most common symptom, but tremors can also affect the head, arms, voice, legs, and torso. For these patients, performing everyday tasks presents a challenge and impacts their quality of life.
The Company holds approximately 89.9% of the share capital of Elbit Medical Technologies Ltd. (TASE:EMTC-M) (85.8% on a fully diluted basis) which, in turn, holds approximately 31.3% of the share capital in INSIGHTEC (26.6% on a fully diluted basis).
Elbit Imaging Ltd. Announces Update Regarding Certain Agreements Executed In The Past By Its Subsidiary Plaza Centers
TEL AVIV, ISRAEL / ACCESSWIRE / April 21, 2017 / Elbit Imaging Ltd. ("Company") (TASE, NASDAQ: EMITF) announced today, in further to its announcement dated March 29, 2016, with respect to the Casa Radio Project in Romania ("Project"), that Plaza Centers N.V. ("Plaza") (PLAZ.L), an indirect subsidiary of the Company, is still co-operating fully with the relevant Romanian Authorities and within this process, Plaza received immunity from certain potential criminal charges. As the investigation of the Romanian authorities is still on-going, Plaza is unable to elaborate any further in this respect.
Plaza was assured that the mentioned investigation should have no effect on Plaza's existing legal rights in the Project and the Public-Private Partnership Agreement signed with respect thereto.
Elbit Imaging Announces that its Subsidiary, Plaza Centers Opened Belgrade Plaza to the Public
TEL AVIV, ISRAEL / ACCESSWIRE / April 21, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE, NASDAQ: EMITF) announced today, that Plaza Centers N.V. ("Plaza") (PLAZ.L), an indirect subsidiary (45%) of the Company, has successfully opened Belgrade Plaza shopping center to the public, yesterday, 20 April. The completed center is 97% let and expected to be fully leased in the coming months. Belgrade Plaza is the 34th shopping center built by Plaza and its second scheme in Serbia.
As previously announced, one of Plaza's subsidiaries signed a binding share purchase agreement with BIG Shopping Centers Ltd., a publicly traded company listed in the TA 35 Index (the top 35 companies traded on the Tel Aviv Stock Exchange) (the "Purchaser"), for the sale of the Belgrade Plaza shopping and entertainment center.
In line with the agreement with the Purchaser, Plaza will receive Euro 2 million for fulfilling its conditions around the successful opening of the center.
In line with Plaza's stated amended restructuring Plan, 75% of the net proceeds will be distributed to Plaza's bondholders. Future proceeds are expected subject to conditions being met, details of which can be found in the completed sale announcement, dated 2 March 2017.
INSIGHTEC: First Patient with Benign Brain Tumor has Focused Ultrasound Procedure at Nicklaus Children’s Hospital
HAIFA, Israel, April 20, 2017 /PRNewswire/ --
INSIGHTEC congratulates Nicklaus Children's Hospital, part of the Miami Children's Health System, for performing the first focused ultrasound procedure on a 21-year old patient suffering seizures associated with a benign hypothalamic hamartoma brain tumor.
Hypothalamic hamartoma is a rare, benign (non-cancerous) brain tumor that can cause different types of seizures, cognitive problems or other symptoms. While the exact number of people with hypothalamic hamartomas is not known, it is estimated to occur in one out of 200,000 children and teenagers worldwide.
The medical team at Nicklaus Children's Hospital is performing MR-guided Focused Ultrasound (MRgFUS) using the Exablate Neuro system as part of an FDA-approved feasibility study. The goal of the pilot study is to gather the preliminary safety profile of this incisionless ablative treatment for benign centrally-located intracranial tumors in pediatric and young adults. The MRgFUS procedure involves applying high energy ultrasound waves guided by magnetic resonance imaging (MRI) to heat and ablate the target tumor, without impacting the scalp, skull or surrounding healthy brain tissue.
The medical and research team at Nicklaus Children's is led by Dr. John Ragheb, Director of Division of Neurosurgery; Dr. Travis Tierney, Principal Investigator; Dr. Ian Miller, Director of Epilepsy Program; Dr. Sanjiv Bhatia, neurosurgeon; Dr. Nolan Altman, Director of Radiology; Dr. Prasanna Jayakar, Chairman of the Brain Institute at Nicklaus Children's Hospital; and Dr. Jennifer McCafferty, Director of Research, Miami Children's Research Institute.
"This breakthrough first procedure sets the stage for us to provide incisionless surgery for young patients with benign centrally-located brain tumors. Our team is encouraged by the potential of focused ultrasound technology to positively impact lives," said Prasanna Jayakar, MD, PhD, Chairman of the Brain Institute at Nicklaus Children's Hospital.
"We applaud the team at Nicklaus Children's for their commitment to treating children with various brain conditions. Their pioneering research with our MRgFUS technology offers hope that significant groups of pediatric patients will be able to undergo treatment without any surgical incision, minimizing or eliminating the risk of infection or other surgical complications," said Maurice R. Ferré MD, CEO and Chairman of INSIGHTEC.
"The needs of pediatric patients emphasize some of the important advantages of focused ultrasound. It is incisionless, avoids ionizing radiation, offers less risk of infection and disruption of adjacent normal tissue than surgery, and patients often return to normal activities within days," says Focused Ultrasound Foundation's Chief Medical Officer, Tim Meakem, MD. "These benefits are especially important in neurosurgery, and researchers around the world are investigating other areas where this innovative care could improve outcomes for patients of all ages. The Foundation congratulates the entire team of Nicklaus Children's Hospital and INSIGHTEC for this breakthrough achievement."
Funds for the study have been provided by the Focused Ultrasound Foundation. Regulatory sponsorship has been provided by INSIGHTEC.
To read the Nicklaus Children's Hospital press release, please click here .
About INSIGHTEC
INSIGHTEC is the world leader and innovator of MR-guided Focused Ultrasound (MRgFUS). The company's non-invasive therapy platforms, Exablate and Exablate Neuro, are proven technology based on sound clinical evidence for treating essential tremor, painful bone metastases and uterine fibroids. The company is dedicated to improving patient lives by collaborating with physicians, medical institutions, academic researchers and regulatory bodies around the world. For more information, please visit: http://www.insightec.com.
About Nicklaus Children's Hospital
Founded in 1950 by Variety Clubs International, Nicklaus Children's Hospital - part of Miami Children's Health System - is South Florida's only licensed specialty hospital exclusively for children, with more than 740 attending physicians and over 220 pediatric subspecialists. The 289-bed hospital is renowned for excellence in all aspects of pediatric medicine with several specialty programs routinely ranked among the best in the nation by U.S. News & World Report. The hospital is also home to the largest pediatric teaching program in the southeastern United States and has been designated an American Nurses Credentialing Center (ANCC) Magnet facility, the nursing profession's most prestigious institutional honor. For more information, please visit http://www.nicklauschildrens.org.
About the Focused Ultrasound Foundation
The Focused Ultrasound Foundation was created to improve the lives of millions of people worldwide by accelerating the development of focused ultrasound, an early-stage, noninvasive, therapeutic technology with the potential to transform the treatment of many serious medical disorders. The Foundation works to clear the path to global adoption by coordinating and funding research, fostering collaboration, and building awareness among patients and professionals. It is dedicated to ensuring that focused ultrasound finds its place as a mainstream therapy for a range of conditions within years, not decades. Since its establishment in 2006, the Foundation has become the largest non-governmental source of funding for focused ultrasound research. More information can be found at http://www.fusfoundation.org.
Media Contact:
Carolyn Tiernan
Red Lorry Yellow Lorry for INSIGHTEC
+1(617)237-0922 x 411
Insightec@rlyl.com
SOURCE INSIGHTEC
Gamida Cell Announces Publication of Positive Clinical Outcomes from NiCord-Transplanted Patients in the Journal of Biology of Blood and Marrow Transplantation
PR Newswire
JERUSALEM, April 20, 2017 /PRNewswire/ -- Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, announced today the publication of positive clinical outcomes from an investigator-initiated study of NiCord®-transplanted patients in Biology of Blood and Marrow Transplantation (BBMT), the official publication of the American Society for Blood and Marrow Transplantation.
The article, titled "Transplantation of Ex Vivo Expanded Umbilical Cord Blood (NiCord) Decreases Early Infection and Hospitalization", highlights data underscoring key benefits associated with NiCord over standard umbilical cord blood (UCB) transplantation, including shorter time to engraftment, fewer infections and shorter hospital stays.
"Our results indicate that rapid hematopoietic recovery from Gamida Cell's NiCord transplantation approach is associated with clinical benefit. Reducing the burden of infections is important, as these are a major cause of early morbidity and death of patients following UCB transplantation," said Mitchell Horwitz, M.D., Professor of Medicine and Director, Adult Blood and Marrow Transplant Program at Duke University Medical Center and principal investigator of the study.
"NiCord continues to demonstrate significant advantages over standard UCB transplantation in clinical efficacy and in pharmaco-economic parameters enhancing our understanding of the market potential of the product," said Yael Margolin, Ph.D., President and Chief Executive Officer of Gamida Cell. "Our Phase 3 registration trial of NiCord is ongoing in which we hope to reproduce these important results in a larger patient population."
The study compared 18 consecutive NiCord-transplanted patients and 86 consecutive standard umbilical cord blood (UCB) transplanted patients with all patients receiving TBI-based myeloablative conditioning. The data highlights from the study that were published in BBMT include:
Statistically significant improvement in time to engraftment: Median time to neutrophil engraftment in NiCord patients was 12.5 days (range 10-18) compared to 27 days (range 23-28) in standard UCB patients (p<.001).
Decrease in bacterial and non-viral grade 2-3 infections: Frequency with NiCord patients versus standard UCB patients was 22% vs. 54%, respectively (p=.015). In addition, a univariate and multivariate analysis revealed significantly reduced risk ratio for all bacterial (0.35, p=.001) and grade 2-3 non-viral infection (0.16, p<.001) in NiCord patients versus standard UCB patients.
Meaningful reduction in duration of hospitalization: NiCord patients had 21.51 (95% CI 8.25, 34.78) more days alive and out of the hospital in the first 100 days compared to standard UCB patients (p=.002) after adjustment for age, KPS and acute grade 3-4 GVHD.
NiCord is currently being studied in an international, multi-center, Phase 3 registration study as a graft for bone marrow transplantation for patients with blood cancer who do not have a rapidly available fully matched donor. The Company announced in February 2017 that the first patient in the study had been transplanted. NiCord has an FDA Breakthrough Therapy Designation as well as FDA and EMA orphan drug designations, the most recent granted in March 2017.
For more information on enrolling transplantation centers and study inclusion and exclusion criteria please click here.
About NiCord
NiCord is a stand-alone graft derived from a single umbilical cord blood unit which has been expanded in culture and enriched with stem and progenitor cells using Gamida Cell's proprietary NAM technology. NiCord leverages the advantage of umbilical cord blood which does not need full tissue matching to the patient, and can therefore be available to practically all patients in need. It also aims to address the major barrier of umbilical cord blood transplantation - delayed hematopoietic recovery - by demonstrating an advantage with a primary endpoint that is clinically meaningful.
About Gamida Cell
Gamida Cell is a world leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases. The company's pipeline of products are in development to treat a wide range of conditions including cancer, genetic hematological diseases such as sickle cell disease and thalassemia, bone marrow failure syndromes such as aplastic anemia, genetic metabolic diseases and refractory autoimmune diseases. Gamida Cell's current shareholders include Novartis, Elbit Imaging, Clal Biotechnology Industries, Israel Healthcare Venture, Denali Ventures and Auriga Ventures. For more information please visit www.gamida-cell.com.
Press Contact:
Marjie Hadad
MH Communications
+972-54-536-5220
marjierhadad@gmail.com
Investor Contact:
Beth DelGiacco
Stern Investor Relations, Inc.
+1-212-362-1200
beth@sternir.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/gamida-cell-announces-publication-of-positive-clinical-outcomes-from-nicord-transplanted-patients-in-the-journal-of-biology-of-blood-and-marrow-transplantation-300442572.html
SOURCE Gamida Cell
PR Newswire
www.prnewswire.com
More: http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=215869#.WPi0eNR95kg#ixzz4enNBVmPp
Gamida Cell Announces Publication of Positive Clinical Outcomes from NiCord-Transplanted Patients in the Journal of Biology of Blood and Marrow Transplantation
PR Newswire
JERUSALEM, April 20, 2017 /PRNewswire/ -- Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, announced today the publication of positive clinical outcomes from an investigator-initiated study of NiCord®-transplanted patients in Biology of Blood and Marrow Transplantation (BBMT), the official publication of the American Society for Blood and Marrow Transplantation.
The article, titled "Transplantation of Ex Vivo Expanded Umbilical Cord Blood (NiCord) Decreases Early Infection and Hospitalization", highlights data underscoring key benefits associated with NiCord over standard umbilical cord blood (UCB) transplantation, including shorter time to engraftment, fewer infections and shorter hospital stays.
"Our results indicate that rapid hematopoietic recovery from Gamida Cell's NiCord transplantation approach is associated with clinical benefit. Reducing the burden of infections is important, as these are a major cause of early morbidity and death of patients following UCB transplantation," said Mitchell Horwitz, M.D., Professor of Medicine and Director, Adult Blood and Marrow Transplant Program at Duke University Medical Center and principal investigator of the study.
"NiCord continues to demonstrate significant advantages over standard UCB transplantation in clinical efficacy and in pharmaco-economic parameters enhancing our understanding of the market potential of the product," said Yael Margolin, Ph.D., President and Chief Executive Officer of Gamida Cell. "Our Phase 3 registration trial of NiCord is ongoing in which we hope to reproduce these important results in a larger patient population."
The study compared 18 consecutive NiCord-transplanted patients and 86 consecutive standard umbilical cord blood (UCB) transplanted patients with all patients receiving TBI-based myeloablative conditioning. The data highlights from the study that were published in BBMT include:
Statistically significant improvement in time to engraftment: Median time to neutrophil engraftment in NiCord patients was 12.5 days (range 10-18) compared to 27 days (range 23-28) in standard UCB patients (p<.001).
Decrease in bacterial and non-viral grade 2-3 infections: Frequency with NiCord patients versus standard UCB patients was 22% vs. 54%, respectively (p=.015). In addition, a univariate and multivariate analysis revealed significantly reduced risk ratio for all bacterial (0.35, p=.001) and grade 2-3 non-viral infection (0.16, p<.001) in NiCord patients versus standard UCB patients.
Meaningful reduction in duration of hospitalization: NiCord patients had 21.51 (95% CI 8.25, 34.78) more days alive and out of the hospital in the first 100 days compared to standard UCB patients (p=.002) after adjustment for age, KPS and acute grade 3-4 GVHD.
NiCord is currently being studied in an international, multi-center, Phase 3 registration study as a graft for bone marrow transplantation for patients with blood cancer who do not have a rapidly available fully matched donor. The Company announced in February 2017 that the first patient in the study had been transplanted. NiCord has an FDA Breakthrough Therapy Designation as well as FDA and EMA orphan drug designations, the most recent granted in March 2017.
For more information on enrolling transplantation centers and study inclusion and exclusion criteria please click here.
About NiCord
NiCord is a stand-alone graft derived from a single umbilical cord blood unit which has been expanded in culture and enriched with stem and progenitor cells using Gamida Cell's proprietary NAM technology. NiCord leverages the advantage of umbilical cord blood which does not need full tissue matching to the patient, and can therefore be available to practically all patients in need. It also aims to address the major barrier of umbilical cord blood transplantation - delayed hematopoietic recovery - by demonstrating an advantage with a primary endpoint that is clinically meaningful.
About Gamida Cell
Gamida Cell is a world leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases. The company's pipeline of products are in development to treat a wide range of conditions including cancer, genetic hematological diseases such as sickle cell disease and thalassemia, bone marrow failure syndromes such as aplastic anemia, genetic metabolic diseases and refractory autoimmune diseases. Gamida Cell's current shareholders include Novartis, Elbit Imaging, Clal Biotechnology Industries, Israel Healthcare Venture, Denali Ventures and Auriga Ventures. For more information please visit www.gamida-cell.com.
Press Contact:
Marjie Hadad
MH Communications
+972-54-536-5220
marjierhadad@gmail.com
Investor Contact:
Beth DelGiacco
Stern Investor Relations, Inc.
+1-212-362-1200
beth@sternir.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/gamida-cell-announces-publication-of-positive-clinical-outcomes-from-nicord-transplanted-patients-in-the-journal-of-biology-of-blood-and-marrow-transplantation-300442572.html
SOURCE Gamida Cell
PR Newswire
www.prnewswire.com
More: http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=215869#.WPi0eNR95kg#ixzz4enNBVmPp
Elbit Imaging Limited Ord (NASDAQ:EMITF) had an increase of 6895% in short interest. EMITF’s SI was 139,900 shares in April as released by FINRA. It's up 6895% from 2,000 shares previously.
http://normanobserver.com/analysts-at-cantor-fitzgerald-reiterate-their-buy-rating-for-gulf-keystone-petroleum-longkp-with-gbx-270-00-price-objective-elbit-imaging-limited-ord-emitf-si-increased-by-6895/
Lol, "unusally high volume" of 9,899 whole shares. $35,000 in trades.
Even you claim to hold more shares than that, starteam003.
Midas..why we getting unusually high volume and high stock price movements today in TASE? I thought we had " bad " news yesterday? ????????
What is your "nagging wife" gonna say about that, starteam003?
Midas..are they filing bankruptcy?!?!?!
Elbit Imaging Announces Delay in the Publication of the Financial Results of its Subsidiary, Plaza Centers
Accesswire AccesswireApril 3, 2017
TEL AVIV, ISRAEL / ACCESSWIRE / April 3, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE, NASDAQ: EMITF) announced today that the audit process of Plaza Centers N.V. ("Plaza") (LSE: PLAZ), an indirect subsidiary (45%) of the Company, annual financial statements is still ongoing and, therefore, there will be a delay in the publication of Plaza's financial results for the year ended 31 December 2016. Work is being undertaken to address the situation with a view to announcing the financial results as soon as possible. Without any connection to the above-mentioned delay, Plaza's annual financial statements, when published, will include a "going concern" note.
Due to the above-mention delay, EI cannot publish its annual financial results by the end of March, as it did in previous years.
Midas..how come the stock price won't go up? It's so damn frustrating ??????
Elbit Imaging Ltd. Announces that First Treatment was Performed Under Insightech's Phase I Clinical Trial for Opening the Blood Brain Barrier in Patients with Early Alzheimer's Disease
TEL AVIV, ISRAEL / ACCESSWIRE / March 27, 2017 / Elbit Imaging Ltd. (TASE, NASDAQ: EMITF) ("Elbit" or the "Company") announced today that the first treatment was performed under Phase I clinical trial to investigate the use of Magnetic Resonance Imaging guided by Focused Ultrasound (MRgFUS) technology for opening the blood brain barrier in patients with early Alzheimer's disease. The treatment was conducted at Sunnybrook Health Sciences Centre in Toronto, Canada and use the INSIGHTEC's Exablate Neuro system. INSIGHTEC is the regulatory sponsor of the clinical trial.
The purpose of the study is to evaluate the safety and feasibility of low frequency MRgFUS to temporarily open the blood-brain barrier ("BBB") in patients with mild to moderate Alzheimer's disease. This is the first human application of MRgFUS in Alzheimer's patients.
The BBB is a protective barrier that restricts the passage of substances from the bloodstream into the brain, protecting it from toxic chemicals. This barrier also prevents the delivery of essential medication to reach the brain.
The Company holds approximately 89.9% of the share capital of Elbit Medical Technologies Ltd. (TASE:EMTC-M) (85.8% on a fully diluted basis) which, in turn, holds approximately 31.3% of the share capital in INSIGHTEC (26.6% on a fully diluted basis).
Elbit Imaging Ltd. Announces that an EMA Orphan Drug Designation has been Granted to Gamida Cell
TEL AVIV, ISRAEL / ACCESSWIRE / March 23, 2017 / Elbit Imaging Ltd. (TASE, NASDAQ: EMITF) ("Elbit" or the "Company") announced today, that it was informed by Gamida Cell Ltd. ("Gamida"), an indirect associate of the Company, that the orphan drug designation, which has been granted by the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) regarding NiCord®, has been broadened and now includes any treatment which is based on blood system stem cells (haematopoetic stem cells) transplant.
The EMA grants an orphan drug designation to promote the development of products that demonstrate promise for the treatment of rare diseases. EMA Orphan drug designation provides 10 years of market exclusivity in the EU, as well as prospective grants receiving easement and assistance with developing and registration of drugs for marketing.
As of today, the development of NiCord® remains at the clinical stage of development, and there is no certainty that NiCord® will be marketed on a commercial basis.
The Company holds approximately 89.9% of the share capital of Elbit Medical Technologies Ltd. (TASE:EMTC-M) (85.8% on a fully diluted basis) which, in turn, holds approximately 25% of the share capital in Gamida (22.5% on a fully diluted basis).
Gamida Cell Receives Additional EMA Orphan Drug Designation for NiCord® in Haematopoietic Stem Cell Transplantation (HSCT)
Phase 3 study of NiCord commenced last month in blood cancer patients
JERUSALEM, March 23, 2017 /PRNewswire/ -- Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, announced today that orphan drug designation has been granted by the European Medicines Agency's (EMA's) Committee for Orphan Medicinal Products (COMP) regarding NiCord® as a treatment for haematopoietic stem cell transplantation, also commonly known as bone marrow transplantation (BMT).
"We are very encouraged that the EMA has widened NiCord's orphan drug designation to include BMT, and believe it is an important recognition of the unmet needs in these indications," said Gamida Cell president and CEO Dr. Yael Margolin. "This broadened regulatory designation adds a key layer of market exclusivity for NiCord as we move forward with our Phase 3 study and prepare for commercialization."
The EMA grants an orphan drug designation to promote the development of products that demonstrate promise of significant benefit for the treatment of rare diseases. Products receiving orphan drug designation are eligible to receive various regulatory and economic benefits, including 10 years of market exclusivity in the EU.
Gamida Cell was previously granted orphan drug designation for NiCord by the EMA for acute myeloid leukemia (AML), and by the U.S. Food and Drug Administration (FDA) for the treatment of several hematologic malignancies including AML, acute lymphoblastic leukemia (ALL), Hodgkin's lymphoma, myelodysplastic syndromes (MDS) and chronic myelogenous leukemia (CML). Gamida Cell also received FDA Breakthrough Therapy Designation for NiCord in blood cancers.
NiCord® is currently being studied in an international, multi-center, Phase 3 registration study as a graft for bone marrow transplantation for patients with blood cancer who do not have a rapidly available fully matched donor. The Company announced last month that the first patient in the study had been transplanted.
For more information on enrolling transplantation centers and study inclusion and exclusion criteria please click here.
About NiCord®
NiCord is a stand-alone graft derived from a single umbilical cord blood unit which has been expanded in culture and enriched with stem and progenitor cells using Gamida Cell's proprietary NAM technology. NiCord leverages the advantage of umbilical cord blood which does not need full tissue matching to the patient, and can therefore be available to practically all patients in need. It also aims to address the major barrier of umbilical cord blood transplantation - delayed hematopoietic recovery - by demonstrating an advantage with a primary endpoint that is clinically meaningful.
About Gamida Cell
Gamida Cell is a world leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases. The company's pipeline of products are in development to treat a wide range of conditions including cancer, genetic hematological diseases such as sickle cell disease and thalassemia, bone marrow failure syndromes such as aplastic anemia, genetic metabolic diseases and refractory autoimmune diseases. Gamida Cell's current shareholders include Novartis, Elbit Imaging, Clal Biotechnology Industries, Israel Healthcare Venture, Teva Pharmaceutical Industries, Denali Ventures and Auriga Ventures. For more information please visit www.gamida-cell.com.
Press Contact:
Marjie Hadad
MH Communications
+972-54-536-5220
marjierhadad@gmail.com
midas..still have 10,000 shares..holding LONG
Just imagine how rich you'd be if you had bought Apple instead.
Yes fellas still have my 10,000 shares..and yes I'm 25 years live in Hong Kong ????
What happened to 70 and retired?
What is that exactly that
you do not understand in
the latest PR?
Elbit Imaging Announces Availability of Presentation on its Website
TEL AVIV, ISRAEL / ACCESSWIRE / March 9, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE, NASDAQ: EMITF) announced today, that it has placed a presentation with respect to Radisson Blu hotel in Bucharest on the Company's website at www.elbitimaging.com under "Investor Relations - Group Presentations."
Midas..what's the latest PR really mean?
Elbit Imaging Ltd. Announces an Extension to the Debt of Elbit Medical Technologies Ltd. Maturity Date
TEL AVIV, ISRAEL / ACCESSWIRE / March 9, 2017 / Elbit Imaging Ltd. (the "Company") (TASE, NASDAQ: EMITF) announced today, in furtherance to its announcement dated November 28, 2016, that the Company's board of directors has accepted Elbit Medical Technologies Ltd.'s ("Elbit Medical") request to extend the maturity date of Elbit Medical's Debt to the Company such that the new maturity date of all Elbit Medical's Debt to the Company shall be October 1, 2018.
Today in the Naz too!
Hey Midas..why TASE up big time today? Any clue?
Midas..it seems management is making all the right moves..investment funds too ??
Elbit Imaging Ltd. Announces that Gamida Cell's Has Signed a Non-Binding Term Sheet with Investment Fund
TEL AVIV, ISRAEL / ACCESSWIRE / March 8, 2017 / Elbit Imaging Ltd. (TASE, NASDAQ: EMITF) ("Elbit" or the "Company") announced today, that it was informed by Gamida Cell Ltd. ("Gamida"), an indirect associate of the Company, that Gamida has signed a non-binding Term sheet ("TS") with investment fund ("Investment Fund") with respect to investment in Gamida.
According to the TS, the Investment Fund shall lead an investment of USD 30 million, with additional investors, at a pre-money value of USD 120 million (the "Investment"). As a consideration, the Investment Fund and the additional investors shall acquire preferred shares and options for preferred shares of Gamida and will be entitled to some additional rights, including certain anti-dilution rights in Gamida.
As of the date herein, there is no certainty that a definitive agreement will be signed and/or that additional investors will participate in the Investment and/or that the Investment will be completed.
The Company holds approximately 89.9% of the share capital of Elbit Medical Technologies Ltd. (TASE:EMTC-M) (85.6% on a fully diluted basis) which, in turn, holds approximately 25% of the share capital in Gamida (22.5% on a fully diluted basis).
Signed a memorandum of understanding to invest $ 30 million Gamida
http://www.sponser.co.il/Article.aspx?ArticleId=78018&From=morearticles
(Goog Translate)
The company owned by Elbit Medical and CBI signed a non-binding memorandum of understanding with an investment fund at a value of $ 120 million against preference shares, options, etc.
08/03/2017 |8:57 |A sponsor |4 Add a comment | Print Article |
Want to trade cheaply through the bank?
Elbit Medical Technologies and Clal Biotechnology TASE announced that yesterday (Tuesday) announced Gamida them, held them at a rate of approximately 25% and 18%, respectively, that was signed with an investment fund for a non-binding memorandum of understanding to invest Gamida.
According to the MOU, will lead to investment fund investment of $ 30 million, along with other investors, based Gamida value of $ 120 million, before money. In return the said investment, the investors will receive preferred stock and warrants to purchase preferred shares of Gamida and other rights, including the protection of certain anti-dilution.
Recall that the CBI announced earlier this week that an agreement with the pharmaceutical company Teva acquisition of all holdings of nature (approximately -5.02% fully diluted) in Gamida, including all rights attaching to them. Following the acquisition of the shares of the acquired company will increase its stake to about Gamida 24%. According to the agreements between the parties, the value of the acquired shares is approximately $ 6 million, reflecting a company value of $ 120 million Gamida. acquired shares, the Company will issue shares of the Company to nature.
and and / or that the investment will be recruited additional investors and / or that the investment is completed. Gamida began CBI Elbit stressed as of this morning, there is no certainty that it will sign an investment agreement Final to experiment III Phase in patients with blood cancer and cancer lymph nodes. At the same time conducting Gamida Tests II Phase malignant blood diseases such as sickle cell anemia and thalassemia. the main drug of Gamida cell, NiCord, has been recognized by the FDA as an orphan drug and a treatment breakthrough.
2033? I'll be 40 years old by then!!! ??
All in due time, by 2033
for sure, i guess!
Midas..how come the stock price hasn't move up yet? EMITF should be at least $ 6 by now !!!??
Teva swaps Gamida Cell stake for Clal Biotech stake
5 Mar, 2017 17:00
Gali Weinreb
Teva is selling a 5% stake in Gamida Cell for $6 million in exchange for an additional stake in Len Blavatnik's Clal Biotechnology.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) and Clal Biotechnology Industries Ltd. (TASE: CBI) today reported two deal that will take place simultaneously. In the first, Teva will sell its stake in cancer treatment company Gamida Cell to Clal Biotechnology, and will increase its holding in Clal Biotechnology in the other. Clal Biotechnology will acquire 5% of Gamida Cell's shares for $6 million, reflected a value of $120 million Gamida Cell. Clal Biotechnology, which is a unit of Clal Industries, is controlled by Len Blavatnik's Access Industries
Gamida Cell recently announced the commencement of Phase III clinical trials, and is considering an IPO sometime in the next two years. Following the deal, Clal Biotechnology will own 24% of Gamida Cell, and its share will be almost as large as that of the largest shareholder in the company, Elbit Medical Technologies Ltd. (TASE:EMTC) (25%). Gamida Cell has another large shareholder – pharmaceutical company Novartis, which twice expressed an interest in acquiring the company, but has not yet gone through with the acquisition. Novartis owns 20% of Gamida Cell, and has undertaken to inject $10 million more into the company, and to take part in any future financing round in order to maintain its 20% holding.
In the second deal, Teva is enlarging its stake in Clal Biotechnology by between 3.5%-7% at a 20% premium on the average market price of the shares during the 10 days preceding the announcement, at a cost of NIS 20 million. This will bring Teva's stake in Clal Biotechnology to 17.5%-21%. The share price of Clal Biotechnology, a biomedical holding company controlled by Clal Industries owner Len Blavatnik, has climbed 30% this year, pushing the company's market cap up to NIS 420 million. Following the deal, the leading shareholders in Clal Biotechnology are Clal Industries (54%), Teva (18%), and Migdal Insurance and Financial Holdings Ltd. (TASE: MGDL) (5%), with the public owning the rest.
Teva's deals are interesting because it is the company's first investment in an innovative company in Israel since Dr. Jeremy Levin was CEO in 2012-2014. Teva's current innovative drug development efforts are focused on brain diseases, and it is therefore reasonable to assume that its interest in Clal Biotechnology results mainly from Luc, a US company that is developing a drug for treatment of depression and schizophrenia.
Luc also has an agreement with Novartis involving a treatment for depression with an estimated potential amounting to hundreds of millions of dollars. Teva also has innovative activity in the cancer field (inherited from Cephalon), but previously declared that this area was not the focus of its development activity. Clal Biotechnology has holdings in a number of cancer treatment companies, including Gamida Cell, BioCancell, and US company Neon Thereapeutics. Teva has had extensive dealings with Clal Biotechnology in the past.
Published by Globes [online], Israel Business News - www.globes-online.com - on March 5, 2017
Midas..do you know why the sudden big jump?
This is probably the reason why:
Teva Pharm sells shares in Gamida Cell, raises stake in Clal Biotech
JERUSALEM, March 5 (Reuters) -
* Teva Pharmaceutical Industries has agreed to sell a small stake in Israel-based Gamida Cell and in return will increase its holdings in Clal Biotechnology, the companies said on Sunday.
* According to the deal, Teva will sell a 5.02 percent stake in Gamida Cell and will then be issued new shares in Clal Biotechnology, increasing its stake to 17.5 percent from 14 percent. That could rise to 21 percent under certain circumstances, such as if a public offering in Gamida Cell is held or if Clal sells the acquired shares in Gamida Cell at a higher price.
* Clal Biotechnology said the agreement increases its own stake in Gamida Cell to 24 percent and values Gamida Cell at $120 million.
* Gamida Cell, which is developing cellular and immune therapies for the treatment of cancer and orphan genetic diseases, has begun a late-stage Phase III trial in patients with leukemia and cancer lymph nodes. (Reporting by Ari Rabinovitch)
http://www.reuters.com/article/teva-pharm-ind-cbi-idUSL5N1GI05G
By summer 2020 maybe
for sure, i guess!
Midas..still here my friend with 10.000 of avg price of $ 6 ..yeah I know it sucks..wondering if the stock price will ever reach that price again..could it?
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