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News Breaks
January 13, 2014
04:55 EDTLIFE, LIFE, LIFE, CYCC, CYCC, CYCC, BLUE, BLUE, BLUE, PJC, PJC, PJC, STEM, STEM, STEM, ATHX, ATHX, ATHX, NBS, NBS, NBS, ONVO, ONVO, ONVO, CYTX, CYTX, CYTX, ISCO, ISCO, ISCOEBD Group to hold a conference
Biotech Showcase 2014 is being held in San Francisco on January 13-15.
News For LIFE;CYTX;ONVO;NBS;ATHX;STEM;PJC;BLUE;CYCC;ISCO From The Last 14 Days
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March 2, 2015
16:09 EDTNBSNeoStem provides 2015 outlook
In 2015, NeoStem's management expects significant additional achievements. The Company's milestones and goals for the year include: Randomization of the first patient for the Intus Phase 3 trial for NBS20 in the second quarter of 2015; Release of one-year data from PreSERVE AMI Phase 2 trial for NBS10 on March 15, 2015 at the Annual Scientific Sessions of the American College of Cardiology; Finalization of decision on next development steps for NBS10 based on PreSERVE primary analysis results in the second half of 2015; Initiation of a Phase 2 study for which NeoStem has received FDA agreement on the protocol to evaluate in adolescents the use of NBS03D, a Treg-based therapeutic being developed to treat type 1 diabetes, in late 2015 or 2016 depending on resource availability; Further exploration of means by which the Company can take advantage of new regulations in Japan that permit conditional approval for regenerative medicine products that show sufficient safety evidence and signals of efficacy; Continued growth of the Company's client services business; Advancement of initiatives to lower costs and improve efficiency of manufacturing in anticipation of production for NeoStem's own products and those of its clients.
09:22 EDTATHXOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Amira Nature Foods (ANFI), up 8.6%... Stratasys (SSYS), up 3.6%... Magnum Hunter (MHR), up 3%. ALSO HIGHER: Mavenir Systems (MVNR), up 19.1% after Mitel (MITL) agrees to acquire Mavenir Systems for $560M... Athersys (ATHX), up 19.7% following license agreement and collaboration with Chugai... OHR Pharmaceutical (OHRP), up 11.4% following additional positive data from OHR-102 IMPACT study... NXP Semiconductors (NXPI), up 14% following merger agreement with Freescale Semiconductor (FSL). Freescale Semiconductor is up 9.1%... Mast Therapeutics (MSTX), up 7.7% following positive results from Vepoloxamer study. DOWN AFTER EARNINGS: JinkoSolar (JKS), down 4.7%... Scorpio Tankers (STNG), down 4.5%. ALSO LOWER: Lumber Liquidators (LL), down 24.2% following CBS' 60 Minutes says that the company is linked to health and safety violations... Aruba Networks (ARUN), down 1.7% after HP (HPQ) confirms deal to acquire Aruba Networks for $24.67... Pacira Pharmaceuticals (PCRX), down 14.4% after receiving complete response letter from FDA for sNDA in use of Exparel... 500.com (WBAI), down 14.4% after announcing that temporary suspension will adversely impact financial results.
05:58 EDTATHXAthersys and Chugai enter license agreement and collaboration
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February 27, 2015
17:48 EDTONVOOrganovo files $190M mixed securities shelf
February 26, 2015
08:02 EDTCYTXCytori Therapeutics says receives FDA approval to expand Scleroderma trial
Cytori Therapeutics announced that it received approval from FDA to expand the number of Scleroderma clinical trial sites from 12 to 20 centers in the United States. The STAR study is an 80 patient pivotal clinical trial approved by FDA in January to study the effects of Cytori’s lead drug ECCS-50 for treatment of patients with hand manifestations of Scleroderma.
06:33 EDTBLUEbluebird bio price target raised to $119 from $112 at Piper Jaffray
Piper Jaffray raised its price target for bluebird bio to $119 following the company's Q4 results and reiterates an Overweight rating on the name. Piper sees 2015 as a "big year" for bluebird with preliminary sickle cell data.
February 25, 2015
16:03 EDTBLUEbluebird bio reports Q4 EPS (67c), consensus (57c)
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February 24, 2015
08:17 EDTCYTXCytori Therapeutics receives positive European opinion on orphan drug status
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07:33 EDTATHXMaxim to hold a discussion
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February 23, 2015
07:22 EDTBLUESunTrust to hold a conference
2015 Biotechnology and Pharmaceutical 1:1 Orphan Drug Day is being held in New York on February 23.
February 19, 2015
07:12 EDTBLUEWharton Health Care Club to hold a conference
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February 17, 2015
08:03 EDTCYTXCytori Therapeutics begins enrollment in Phase II ACT-OA trial
Cytori Therapeutics announced that the first patient has been treated in its FDA approved trial assessing the effect of Cytori Cell Therapy for osteoarthritis of the knee. The patient was treated by Dr. Peter Hanson, Medical Director of Orthopedic Surgery at Sharp Grossmont Hospital. ACT-OA is a Phase II FDA approved randomized, double-blind, placebo controlled trial in 90 patients evaluating the efficacy and safety of Cytori’s autologous adipose derived therapy ECCO-50 (Cytori’s therapeutic under study). The trial tests both a low dose and a high dose vs. placebo and will be conducted over 48 weeks. The randomization will be 1:1:1 between the control, low dose and high dose groups. The primary end point will be pain on walking as measured by the Knee Injury and Osteoarthritis Outcome Score at 12 weeks. Secondary endpoints assessed will include pain, joint function, magnetic resonance imaging and adverse events.

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