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News For FLDM;OVSC;STEM;PFE;PSTI;LH;CYTX;LLY;NBS;ATHX;ACTC From The Last 14 Days
Check below for free stories on FLDM;OVSC;STEM;PFE;PSTI;LH;CYTX;LLY;NBS;ATHX;ACTC the last two weeks.
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August 18, 2014
07:57 EDTPFECambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
August 14, 2014
17:05 EDTPFEPfizer says FDA accepted for review BLA for bivalent recombinant LP2086
Pfizer announced that the FDA has accepted for review the Biologics License Application,BLA, for bivalent recombinant LP2086, the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 through 25 year olds. The FDA has also granted Priority Review designation for the BLA, providing an anticipated Prescription Drug User Fee Act, PDUFA, action date of February 14, 2015. “Pfizer has closely collaborated with the FDA since 2008 to develop our meningococcal B vaccine candidate with the intent to help prevent this devastating disease,” said Dr. Emilio Emini, senior vice president of Vaccine Research and Development for Pfizer. “Both the acceptance of Pfizer’s Biologics License Application today, and its Priority Review designation, are significant regulatory milestones that underscore the importance of our efforts to expedite the approval and subsequent availability of our meningococcal B vaccine for U.S. adolescents.”
August 12, 2014
17:07 EDTPFEPfizer announces results from Lyrica studies conducted in China
Pfizer announced top-line results from two placebo-controlled studies conducted in China with Lyrica in patients with postherpetic neuralgia, pain after shingles or PHN, and painful diabetic peripheral neuropathy, pDPN, respectively.The PHN Phase 4 study, A0081276, met its primary endpoint by demonstrating a statistically significant reduction in pain when compared to placebo. Separately, the pDPN Phase 3 study, A0081265, did not meet its primary endpoint, a statistically significant change in endpoint mean pain score relative to placebo. The PHN study was an eight-week, randomized, double-blind, multi-center, placebo-controlled, post-marketing study evaluating the efficacy, safety and tolerability of pregabalin 300mg/day in the treatment of subjects with PHN. For the primary efficacy parameter, change from baseline in weekly mean pain scores, a significant treatment difference of -0.71 points for pregabalin relative to placebo was observed. The safety profile in this study was consistent with the known profile for Lyrica.
16:12 EDTSTEMStemCells reports Q2 EPS (22c), consensus (14c)
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11:20 EDTCYTXCytori Therapeutics reports publication of six month data from scleroderma study
Cytori Therapeutics (NASDAQ: CYTX) today announced that six month outcomes from a 12 patient independent investigator-initiated study using Cytori Cell Therapy to treat scleroderma have been published in the Annals of Rheumatic Disease. Data from the study indicated that treatment with Cytori Cell Therapy was safe and well tolerated through six months. In addition, the data indicated an approximately 50% average improvement across four key, validated endpoints used to assess the clinical status in patients with systemic scleroderma with impaired hand function at two months, with benefits sustained through six month follow-up. “After six month follow up, we are encouraged by the results that have been seen by the investigators in France...The investigators in Marseille have continued to follow the patients and are considering a larger, controlled study based on these positive outcomes,” said Dr. Steven Kesten, Chief Medical Officer, Cytori.
07:50 EDTLHLabCorp management to meet with UBS
Field trip to company headquarters to be held in Burlington, NC on August 12 hosted by UBS.
August 11, 2014
16:27 EDTATHXAthersys reports Q2 EPS (4c), consensus (9c)
Reports Q2 revenue $388K, consensus $610K.
16:21 EDTCYTXCytori Therapeutics announces departure of CFO Mark Saad
Cytori Therapeutics announced that Mark Saad, its CFO, has accepted a new opportunity and will be officially leaving Cytori, effective today. It added, "Cytori has recruited a highly qualified candidate who is extremely familiar with Cytori and is currently employed at a local medical company to be our next CFO and VP Finance. The Company will provide a further update on the CFO candidate, who is anticipated to start in September, on the investor call this afternoon." The board has appointed Dr. Marc Hedrick, Cytori’s CEO, to serve as Principal Financial Officer until a new CFO is appointed.
16:19 EDTCYTXCytori Therapeutics reports Q2 EPS (15c), consensus (13c)
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11:58 EDTLLYMannKind rallies after inking licensing agreement with Sanofi
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August 8, 2014
06:39 EDTPFEPfizer faces torrent of Lipitor suits, Reuters says
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August 7, 2014
16:57 EDTNBSNeoStem reports Q2 revenue $4.5M, consensus $4.75M
Reports Q2 net loss ($12.8M) compared with ($8.6M) for the three months ended June 30, 2013. EPS consensus (30c). At June 30, NeoStem's cash and cash equivalents, and marketable securities totaled $33.8M.
08:12 EDTPFEPfizer says EMA accpets application seeking new indication for Prevenar 13
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06:23 EDTACTCAdvanced Cell Technology to host business news update conference call
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August 6, 2014
12:10 EDTPFEPfizer settles multi-state complaint on improper promotion of Rapamune
Attorney General Eric T. Schneiderman announced that he, along with 40 other state Attorneys General and the District of Columbia, reached a $35M settlement with Pfizer arising from alleged improper marketing and promotion of the immunosuppressive drug Rapamune. New York’s share of the settlement is over $1.7M. Pfizer, as parent of Wyeth Pharmaceuticals, agrees to be bound by the judgment and to resolve allegations that Wyeth unlawfully promoted Rapamune. Attorney General Schneiderman’s office served on the Executive Committee of this multi-state investigation. Reference Link
10:00 EDTCYTXOn The Fly: Analyst Downgrade Summary
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09:13 EDTCYTXOn The Fly: Pre-market Movers
HIGHER: Fox class A shares (FOXA), up 5.9% after withdrawing proposal to acquire Time Warner (TWX), announcing $6B share repurchase program, reporting quarterly results... MannKind (MNKD), up 1.6% after entering a supply agreement with Amphastar Pharmaceuticals (AMPH)... Criteo (CRTO), up 11.5% after upgraded at Goldman following its better than expected Q2 earnings report. LOWER: Time Warner (TWX), down 13% after earnings, maintaining guidance, bid dropped by Fox... Sprint (S), down 16.5% after naming Marcelo Claure as president and CEO, reportedly dropping pursuit of T-Mobile (TMUS). T-Mobile shares also down 8.5%... Groupon (GRPN), down 18%, downgraded at Wunderlich after the company reported lower than expected Q3 results... Walgreen (WAG), down 15.7% after exercises option to acquire remaining 55% of Alliance Boots, says it will not pursue inversion as part of deal... Shire (SHPG), down 6% after Walgreen announced it would stay located in Chicago and Bloomberg last night reported that the Treasury Department is exploring ways to bypass Congress in an attempt to curb corporate inversions... Cytori Therapeutics (CYTX), down 33% after announcing that it has placed enrollment in the ATHENA and ATHENA II trials on clinical hold. UP AFTER EARNINGS: Enphase Energy (ENPH), up 20%... AOL (AOL), up 5%. DOWN AFTER EARNINGS: Nu Skin (NUS), down 8.5%... Rocket Fuel (FUEL), down 27%... Cognizant (CTSH), down 13%... First Solar (FSLR), down 2.5%... Globus Medical (GMED), down 17%.
08:38 EDTCYTXCytori Therapeutics downgraded to Hold from Buy at Ascendiant
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06:23 EDTPFEMitsubishi UFJ to hold a conference
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06:21 EDTPFEPiper Jaffray to hold a summit
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