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News Breaks
May 15, 2014
05:40 EDTGILD, AMGN, CELG, PCYC, BMRN, INCYASCO 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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September 24, 2014
10:01 EDTBMRNBioMarin drops 1% after FDA posts Kuvan Paragraph IV Patent challenge
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09:57 EDTBMRNFDA posts Paragraph IV Patent challenge to BioMarin's Kuvan
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09:34 EDTGILDActive equity options trading on open
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09:28 EDTGILDGilead price target raised to $118 from $111 at Piper Jaffray
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08:39 EDTGILDGilead's two TAF Phase 3 trials meet primary objectives
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07:01 EDTCELGCelgene OTEZLA to become important revenue generator, says Cantor
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05:12 EDTGILDGilead submits NDA to Japan for fixed-dose combination of Ledipasvir/Sofosbuvir
Gilead Sciences announced that the company has submitted a New Drug Application, or NDA, to Japanís Pharmaceutical and Medical Devices Agency, or PMDA, for approval of an investigational once-daily fixed-dose combination of the NS5A inhibitor ledipasvir, or LDV, 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir, or SOF, 400 mg for the treatment of chronic genotype 1 hepatitis C virus, or HCV, infection in adults. The data submitted in the NDA, which include a Japanese Phase 3 study showing 100 percent SVR12 rates, support the use of LDV/SOF for 12 weeks in treatment-naÔve and treatment-experienced patients with chronic genotype 1 HCV infection, including those with cirrhosis. Patients who achieve SVR12 are cured of HCV infection. If approved, LDV/SOF would simplify HCV treatment for genotype 1 patients in Japan to one daily tablet, eliminating the need for interferon and ribavirin, or RBV. LDV/SOF is currently under regulatory review in the United States and European Union.
September 23, 2014
15:21 EDTCELGCelgene announces FDA approves Otezla for treating plaque psoriasis
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13:54 EDTINCYIncyte volatility at historic low on tight six-month range
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08:07 EDTGILDFDA Pediatric Advisory Committee to hold a meeting
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September 22, 2014
09:15 EDTGILDIntercept recent weakness a buying opportunity, says Summer Street
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09:02 EDTAMGNAmgen submits BLA to the FDA for immunotherapy blinatumomab
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07:21 EDTCELGEBD Group to hold a conference
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September 19, 2014
11:26 EDTGILDStocks with call strike movement; TSLA GILD
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09:37 EDTGILDActive equity options trading on open
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06:25 EDTGILDGilead granted marketing aurhotization from European Commission for Zydelig
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06:11 EDTGILDGilead price target raised to $139 from $111 at Citigroup
Citigroup raised its price target for Gilead shares to $139 saying management looks "very optimistic" that FY15 hepatitis C treatment volumes could be up substantially over FY14 rates globally. Citi also expects recent buybacks to boost Q4 earnings substantially and that future stock buybacks will drive appreciation. The firm keeps a Buy rating on Gilead.
September 18, 2014
12:18 EDTBMRNPiper Jaffray biopharm analyst holds an analyst/industry conference call
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12:12 EDTGILDStocks with call strike movement; PIR GILD
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08:17 EDTGILDGilead trial failure not material, says FBR Capital
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