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News Breaks
May 15, 2014
05:40 EDTCELG, PCYC, BMRN, INCY, GILD, AMGNASCO abstracts 'surprisingly bland,' says Piper Jaffray
Piper Jaffray calls the ASCO abstracts released last night as "surprisingly bland," saying it does not find much "surprising or even interesting." Piper now believes the cancer field isn't progressing as quickly as it previously thought. The firm says Incyte (INCY) abstracts were "anticlimactic."
News For INCY;PCYC;AMGN;BMRN;CELG;GILD From The Last 14 Days
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October 21, 2014
07:54 EDTINCYLeerink a buyer of Alkermes, ImmunoGen, Incyte
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07:15 EDTAMGNFDA to hold workshop on breast cancer drug development
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October 20, 2014
13:26 EDTCELGCelgene I&I franchise boosted by Crohn’s trial data, says William Blair
William Blair said it views the preliminary Phase II efficacy and safety data from mongersen in Crohn’s disease reported by Celgene as encouraging. The firm noted that the 10 mg arm did not achieve significance, but the three data points collectively formed a robust dose-response that William Blair said lends support for the drug's proposed mechanism of action. William Blair believes mongersen complements Celgene’s Inflammation & Immunology portfolio and the firm maintains its Outperform rating on the stock, which is up 4% to $91.65 in afternoon trading.
13:21 EDTCELGCelgene reports Phase II data in Crohn’s Disease to be presented at UEG
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09:36 EDTGILDActive equity options trading on open
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08:14 EDTPCYCPharmacyclics files supplmeental NDA for Imbruvica for macroglobulinemia
Pharmacyclics (PCYC) announced that it has submitted a supplemental New Drug Application to the FDA based on data from a Phase 2 study evaluating the use of IMBRUVICA in patients with Waldenstrom's macroglobulinemia. IMBRUVICA, which received FDA Breakthrough Therapy Designation in February 2013 for patients with WM, is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech (JNJ).
07:19 EDTAMGNIBC Life Sciences to hold a conference
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07:10 EDTBMRNAmerican Society of Human Genetics to hold annual meeting
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October 19, 2014
15:56 EDTAMGNAmgen to aid in production method for Ebola drug ZMapp, Bloomberg says
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October 17, 2014
16:01 EDTGILDOptions Update; October 17, 2014
iPath S&P 500 VIX Short-Term Futures down 1.75 to 38.58 Option volume leaders: AAPL TSLA TWTR AMZN FB NFLX GILD CLF PBR according to Track Data.
13:18 EDTCELGLeerink's biotech analyst holds an analyst/industry conference call
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09:38 EDTGILDActive equity options trading on
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09:06 EDTAMGNAmgen files patent infringement lawsuit against Sanofi, Regeneron
Amgen (AMGN) announced that it filed a lawsuit in the United States District Court of Delaware against Sanofi (SNY), Aventisub, formerly doing business as Aventis Pharmaceuticals, and Regeneron Pharmaceuticals (REGN) for patent infringement of U.S. Patent Numbers 8,563,698, 8,829,165, and 8,859,741. These patents, which are owned by Amgen, describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9, or PCSK9. By its complaint, Amgen seeks an injunction to prevent the infringing manufacture, use and sale of Sanofi and Regeneron's alirocumab, a monoclonal antibody targeting PCSK9. Sanofi and Regeneron recently announced that they have completed Phase 3 clinical trials on alirocumab and intend to pursue regulatory approval to market alirocumab in the U.S. Amgen previously announced submission of a Biologics License Application to the FDA for evolocumab, its own investigational human monoclonal antibody to PCSK9, for the treatment of high cholesterol, on Aug. 28.
08:57 EDTPCYCPharmacyclics price target raised to $188 from $185 at Roth Capital
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08:51 EDTPCYCPharmacyclics announces European approval for Imbruvica
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08:34 EDTPCYCPharmacyclics management to meet with JPMorgan
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08:01 EDTINCYIncyte names Gryska CFO to succeed Hastings
Incyte announced the appointment of David Gryska as Executive Vice President and CFO, effective October 31. Gryska will succeed David Hastings, who has served as Incyte’s Executive Vice President and CFO since October 2003. Hastings, who is leaving the company to pursue other opportunities, will remain with Incyte through the end of November and will work closely with Gryska to ensure a seamless transition.
October 16, 2014
15:10 EDTCELGAmerican College of Gastroenterology to hold annual meeting
ACG Annual Scientific Meeting 2014 to be held in Philadlephia, PA on October 17-22.
14:47 EDTPCYCRoche in pact with Pharmacyclics to evaluate Imbruvica, Gazyva combo
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13:31 EDTGILDGilead announces Harvoni Notice of Compliance from Health Canada
Gilead Sciences announced that Health Canada has issued a Notice of Compliance for Harvoni. Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, granted marketing authorization under the tradename Sovaldi in December 2013. The efficacy of Harvoni has been established in patients with chronic hepatitis C virus genotype 1 infection, with a treatment duration of eight, 12 or 24 weeks depending on prior treatment history, cirrhosis status and baseline viral load. Eight weeks of treatment with Harvoni can be considered for treatment-naive patients without cirrhosis who have baseline HCV viral load below 6M IU/mL. New Drug Submission applications are pending in Australia and New Zealand.
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