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March 17, 2014
07:40 EDTNBSNeoStem reports fourth data safety monitoring board review of PreSERVE AMI trial
NeoStem announced that, on March 11, the Data Safety Monitoring Board, or DSMB, recommended continuing the PreSERVE AMI Phase 2 clinical trial following a fourth interim data and safety review. The PreSERVE trial of AMR-001 is a Phase 2, randomized, placebo controlled, double-blind study designed to enroll 160 patients. AMR-001 is being evaluated for the preservation of heart function after a severe heart attack. Full enrollment has been completed for the trial and data will be available in the second half of 2014. AMI, significantly reduces the cumulative incidence of major adverse clinical cardiac events, including death, heart failure and recurrent cardiac ischemia1. These data further support the ongoing development of NeoStem's lead product candidate, AMR-001, an autologous bone marrow derived CXCR4 expressing cell that was shown in a Phase 1 trial to induce new blood vessel growth and preserve heart muscle function after a severe heart attack.
News For NBS From The Last 14 Days
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May 6, 2015
06:28 EDTNBSNeoStem to sell $30M, plus 365K commitment shares to Aspire Capital Fund
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May 5, 2015
07:38 EDTNBSNeoStem reports Q1 net loss ex-charges $14.3M vs. $9.3M last year
Reports Q1 revenue $3.17M, consensus $5.25M. Reports Q1 adjusted revenue $4.34M.
April 29, 2015
16:23 EDTNBSNeoStem announces randomization of first patient in Intus Phase 3 clinical trial
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08:33 EDTNBSCryoport supports NeoStem's Intus study for metastatic melanoma treatment
Cryoport (CYRX) is supporting NeoStem's (NBS) Intus Study to evaluate its lead cancer immunotherapy, NBS20, for the treatment of metastatic melanoma. NeoStem is developing an autologous immunotherapy that uses a patient's own tumor cells to maximize the immune system's ability to identify and eliminate the cancer initiating cells that NeoStem believes are capable of reconstituting and developing new tumors. The Intus Study for the treatment of metastatic melanoma has received Special Protocol Assessment and the program has received Fast Track and Orphan Drug Designations from the FDA. Cryoport's cryogenic logistics solution is providing comprehensive support for NeoStem's Intus Study, which is advancing to a Phase 3 trial.
April 27, 2015
07:35 EDTNBSNeoStem says NBS20 receives ATMP classification from EMA
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