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Posted On: 10/07/2014 8:07:00 AM
$BCLI bottom Pr $3.87
Website
NEW YORK and PETACH TIKVAH, Israel , Oct. 7, 2014 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that the United States Food and Drug Administration (FDA) has designated NurOwn™ as a Fast Track product for the treatment of amyotrophic lateral sclerosis (ALS, or Lou Gehrig's Disease). NurOwn™ consists of autologous mesenchymal stem cells that have been induced to secrete neurotrophic factors, and is currently being studied in a randomized, double-blind, placebo-controlled phase 2 clinical trial in ALS patients.
"We are pleased that the FDA has granted Fast Track status for NurOwn™ as this will allow us greater and more frequent dialogue with the Agency as we continue the development of this ground-breaking cell therapy for the treatment of ALS," said Tony Fiorino , MD, PhD, Chief Executive Officer of BrainStorm. "We expect Fast Track designation, which recognizes the potential of NurOwn™ as to address an unmet medical need in ALS, to help speed and improve our development program."
The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs and biologics intended to treat serious conditions and demonstrate the potential to address unmet medical needs. Under the FDA Modernization Act of 1997, the Fast Track program provides for increased meetings with and written communications from the FDA, and allows for the submission of an NDA on a rolling basis. For more information, see http://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm .
About BrainStorm Cell Therapeutics Inc.
BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn™ technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University . NurOwn™ has been administered to over 30 patients with ALS in clinical trials conducted in Israel , and is currently being studied in a randomized, double-blind, placebo-controlled clinical trial in the United States.
Shares Outstanding: 15.16M
Float: 11.34M
Headlines
Tuesday, October 7, 2014
FDA Grants Fast Track Designation to NurOwn™ for the Treatment of ALSPR Newswire
Monday, October 6, 2014
BrainStorm Reports Last Patient Visit in Phase 2a ALS StudyPR Newswire
Friday, October 3, 2014
BRAINSTORM CELL THERAPEUTICS INC. FinancialsEDGAR Online Financials
Tuesday, September 30, 2014
BrainStorm Completes Uplisting to the NASDAQ Capital MarketMarketwired
Tuesday, September 16, 2014
BRAINSTORM CELL THERAPEUTICS INC. Files SEC form 8-K, Material Modification to Rights of Security Holders, AmendmentsEDGAR Online
BrainStorm Announces Completion of Reverse Split of Common Stock, a Key Step for Uplisting on the NASDAQAccesswire
Tuesday, September 9, 2014
BrainStorm Provides Update on NASDAQ Uplisting ProcessMarketwired
Thursday, September 4, 2014
BrainStorm to Present at the Rodman and Renshaw 16th Annual Global Investment ConferenceAccesswire
Wednesday, September 3, 2014
BrainStorm Granted European Patent Covering its Stem Cells for the Treatment of CNS DiseasesAccesswire
Monday, August 18, 2014
FDA Clears Mayo Clinic for Manufacture of NurOwn and Participation in BrainStorm’s Phase 2 ALS TrialAccesswire
Wednesday, August 13, 2014
BCLI: Brainstorm Moves Into Phase 2 ALS TrialZacks Small Cap Research
Wednesday, July 30, 2014
Coverage initiated on Brainstorm Cell Therapeutics by Maxim GroupBriefing.com
Monday, July 28, 2014
BrainStorm Receives Notice of Allowance on US PatentAccesswire
Tuesday, July 15, 2014
BrainStorm Announces that University of Massachusetts Memorial Medical Center to Begin Enrolling Patients in Phase 2 ALS Clinical TrialAccesswire
Friday, July 11, 2014
BrainStorm Announces Publication of Preclinical Multidose Study of NurOwnMarketwired
Friday, June 27, 2014
BrainStorm Cell, Octane construct bioreactor prototype for NurOwntheflyonthewall.com
BrainStorm and Octane Successfully Construct a Bioreactor Prototype for Industrial-Scale Manufacturing or NurOwn Stem CellsMarketwired
Tuesday, June 24, 2014
Brainstorm Cell Therapeutics, Inc.: A Small Biotech With Big Plans And Huge Potentialat Seeking Alpha
Friday, June 13, 2014
BrainStorm Cell Therapeutics Raises $10.5 Million in Private Placement FinancingMarketwired
Thursday, June 12, 2014
BrainStorm Tackles Neurodegenerative Diseases With Novel Cell Therapyat Seeking Alpha
Website
NEW YORK and PETACH TIKVAH, Israel , Oct. 7, 2014 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that the United States Food and Drug Administration (FDA) has designated NurOwn™ as a Fast Track product for the treatment of amyotrophic lateral sclerosis (ALS, or Lou Gehrig's Disease). NurOwn™ consists of autologous mesenchymal stem cells that have been induced to secrete neurotrophic factors, and is currently being studied in a randomized, double-blind, placebo-controlled phase 2 clinical trial in ALS patients.
"We are pleased that the FDA has granted Fast Track status for NurOwn™ as this will allow us greater and more frequent dialogue with the Agency as we continue the development of this ground-breaking cell therapy for the treatment of ALS," said Tony Fiorino , MD, PhD, Chief Executive Officer of BrainStorm. "We expect Fast Track designation, which recognizes the potential of NurOwn™ as to address an unmet medical need in ALS, to help speed and improve our development program."
The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs and biologics intended to treat serious conditions and demonstrate the potential to address unmet medical needs. Under the FDA Modernization Act of 1997, the Fast Track program provides for increased meetings with and written communications from the FDA, and allows for the submission of an NDA on a rolling basis. For more information, see http://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm .
About BrainStorm Cell Therapeutics Inc.
BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn™ technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University . NurOwn™ has been administered to over 30 patients with ALS in clinical trials conducted in Israel , and is currently being studied in a randomized, double-blind, placebo-controlled clinical trial in the United States.
Shares Outstanding: 15.16M
Float: 11.34M
Headlines
Tuesday, October 7, 2014
FDA Grants Fast Track Designation to NurOwn™ for the Treatment of ALSPR Newswire
Monday, October 6, 2014
BrainStorm Reports Last Patient Visit in Phase 2a ALS StudyPR Newswire
Friday, October 3, 2014
BRAINSTORM CELL THERAPEUTICS INC. FinancialsEDGAR Online Financials
Tuesday, September 30, 2014
BrainStorm Completes Uplisting to the NASDAQ Capital MarketMarketwired
Tuesday, September 16, 2014
BRAINSTORM CELL THERAPEUTICS INC. Files SEC form 8-K, Material Modification to Rights of Security Holders, AmendmentsEDGAR Online
BrainStorm Announces Completion of Reverse Split of Common Stock, a Key Step for Uplisting on the NASDAQAccesswire
Tuesday, September 9, 2014
BrainStorm Provides Update on NASDAQ Uplisting ProcessMarketwired
Thursday, September 4, 2014
BrainStorm to Present at the Rodman and Renshaw 16th Annual Global Investment ConferenceAccesswire
Wednesday, September 3, 2014
BrainStorm Granted European Patent Covering its Stem Cells for the Treatment of CNS DiseasesAccesswire
Monday, August 18, 2014
FDA Clears Mayo Clinic for Manufacture of NurOwn and Participation in BrainStorm’s Phase 2 ALS TrialAccesswire
Wednesday, August 13, 2014
BCLI: Brainstorm Moves Into Phase 2 ALS TrialZacks Small Cap Research
Wednesday, July 30, 2014
Coverage initiated on Brainstorm Cell Therapeutics by Maxim GroupBriefing.com
Monday, July 28, 2014
BrainStorm Receives Notice of Allowance on US PatentAccesswire
Tuesday, July 15, 2014
BrainStorm Announces that University of Massachusetts Memorial Medical Center to Begin Enrolling Patients in Phase 2 ALS Clinical TrialAccesswire
Friday, July 11, 2014
BrainStorm Announces Publication of Preclinical Multidose Study of NurOwnMarketwired
Friday, June 27, 2014
BrainStorm Cell, Octane construct bioreactor prototype for NurOwntheflyonthewall.com
BrainStorm and Octane Successfully Construct a Bioreactor Prototype for Industrial-Scale Manufacturing or NurOwn Stem CellsMarketwired
Tuesday, June 24, 2014
Brainstorm Cell Therapeutics, Inc.: A Small Biotech With Big Plans And Huge Potentialat Seeking Alpha
Friday, June 13, 2014
BrainStorm Cell Therapeutics Raises $10.5 Million in Private Placement FinancingMarketwired
Thursday, June 12, 2014
BrainStorm Tackles Neurodegenerative Diseases With Novel Cell Therapyat Seeking Alpha
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