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News Breaks
March 18, 2013
09:26 EDTNVS, INCYIncyte discloses patient treated with ruxolitinib develops PML
Incyte Corporation (INCY) disclosed in a regulatory filing that it was informed last week of a case of progressive multifocal leukoencephalopathy, or PML, in a 75 year old male patient from the United Kingdom with myelofibrosis treated with ruxolitinib. Ruxolitinib is marketed by the company as Jakafi in the United States and by Novartis (NVS) as Jakavi outside the United States, Incyte said. Incyte stated: "It has not been determined whether development of PML in this case was related to the use of ruxolitinib. An independent assessment to confirm the diagnosis and evaluate the causality assessment provided by the investigator is planned. This is the only known case of PML in the approximately 9,800 myelofibrosis patients treated with ruxolitinib worldwide in clinical trials or with commercial product...The Company has informed the U.S. Food and Drug Administration of this case and, as part of its standard procedure for sharing available information in a timely manner, is in the process of informing investigators in its clinical trials." The company added that there are reports in medical literature that "suggest that patients with myeloproliferative neoplasms, including myelofibrosis, may be at higher risk of developing PML." In pre-market trading, Incyte shares fell over 13% to $21.58.
News For INCY;NVS From The Last 14 Days
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March 31, 2015
09:50 EDTNVSMylan launches generic Exforge tablets in U.S.
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March 30, 2015
17:46 EDTNVSNovartis announces FDA approval for Jadenu
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05:18 EDTNVSNovartis enters multiyear aliance with Aduro Biotech
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March 26, 2015
11:13 EDTNVSBofA/Merrill European pharma analyst holds an analyst/industry conference call
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10:18 EDTNVSHigh option volume stocks
High option volume stocks: BTX ALL FIVE SGYP SWFT RHT IDCC NVS WGO XBI
10:10 EDTINCYAnalyst calls sharp pullback in biotech stocks 'misguided'
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06:45 EDTINCYBiotech valuation concerns 'misguided,' says Piper Jaffray
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March 24, 2015
11:05 EDTNVSNovartis granted orphan status for medulloblastoma treatment
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March 23, 2015
09:45 EDTNVSUBS to hold a field trip
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09:03 EDTNVSLeerink analysts hold a meeting with a conference call hookup
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March 20, 2015
12:33 EDTNVSNovartis says CLEAR Phase IIb study met primary endpoint
Novartis announced results from the CLEAR study demonstrating that Cosentyx is significantly superior to Stelara, a widely used biologic, in achieving clear or almost clear skin for psoriasis patients. The detailed findings were presented in a late-breaking research session at the 73rd Annual Meeting of the American Academy of Dermatology in San Francisco, USA. Cosentyx -- at a dose of 300 mg -- is the first and only interleukin-17A inhibitor approved to treat adult patients with moderate-to-severe plaque psoriasis. In this Phase IIIb study, Cosentyx met the primary endpoint of showing superiority to Stelara as assessed by the Psoriasis Area Severity Index 90 response, known as clear to almost clear skin at Week 16. PASI 90 is considered an important measure of treatment success by the European Medicines Agency and an optimal treatment goal for patients. In addition, completely clear skin at Week 16 was achieved by significantly more patients treated with Cosentyx than those receiving Stelara. In addition, Cosentyx demonstrated rapid onset of action and greater efficacy at all time points in the study up to Week 16, with 50% of Cosentyx patients achieving PASI 75 as early as Week 4 compared to Stelara. The CLEAR study follows the pivotal Phase III FIXTURE study, which showed Cosentyx was superior to Enbrel.
07:41 EDTNVSAmerican Academy of Dermatology to hold annual meeting
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March 19, 2015
15:55 EDTNVSAmgen injunction bid for Neupogen biosimilar denied, Reuters reports
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15:13 EDTNVSAmgen denied preliminary injunction for biologics against Novartis, Reuters says

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