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Stock Market & Financial Investment News

News Breaks
March 18, 2013
09:26 EDTINCY, NVSIncyte 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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February 11, 2016
09:40 EDTINCYJakafi trial ends not Incyte 'thesis killer,' says JPMorgan
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09:21 EDTINCYOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Expedia (EXPE), up 8.4%... Tripadvisor (TRIP), up 10.8%... Cisco (CSCO), up 6%... LendingClub (LC), up 8.8%... Tesla (TSLA), up 3.5%... Shire (SHPG), up 3.1%. ALSO HIGHER: 3D Systems (DDD), up 13.4% after reporting preliminary Q4 revenue. DOWN AFTER EARNINGS: Flowers Foods (FLO), down 17.7%... Incyte (INCY), down 14.3%... LivePerson (LPSN), down 16.7%... Twitter (TWTR), down 5.5%... Mylan (MYL), down 12.5%... PepsiCo (PEP), down marginally. ALSO LOWER: Visa (V), down 3% after being downgraded to Neutral from Buy at BofA/Merrill... Mastercard (MA), down 3% after being downgraded to Neutral from Buy at BofA/Merrill.
07:17 EDTNVSLeerink to hold a conference
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07:08 EDTINCYIncyte sees epacadostat entering Phase 3 during 1H16
Incyte (INCY) said its position in the field of JAK inhibition is demonstrated by the ongoing commercial success of Jakafi and by the recent submissions, by Eli Lilly and Company (LLY), seeking regulatory approval of baricitinib for the treatment of rheumatoid arthritis. Baricitinib was licensed to Lilly by Incyte, and met the primary endpoint in all four of its global Phase 3 studies. If approved, Lilly expects to launch baricitinib in early 2017. In addition, epacadostat, Incyte's first-in-class IDO1 inhibitor, is expected to enter Phase 3 during the first half of 2016 in first-line advanced or metastatic melanoma in combination with Merck & Co's pembrolizumab. Multiple Phase 2, tumor-specific, expansion cohorts of epacadostat in combination with anti-PD-1 and anti-PD-L1 checkpoint modulators are also underway.
07:07 EDTINCYIncyte sees FY16 Jakafi revenue $800M-$815M
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07:05 EDTINCYIncyte reports Q4 EPS 29c, consensus 9c
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06:58 EDTINCYIncyte discontinuing studies of ruxolitinib for pancreatic cancer
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05:35 EDTNVSSandoz reports EMA acceptance of MAA for biosimilar pegfilgrastim
Sandoz, a Novartis company and the global leader in biosimilars, announced that the European Medicines Agency, or EMA, has accepted their Marketing Authorization Application, or MAA, for its biosimilar to Amgen's EU-licensed Neulasta - a long-acting recombinant human granulocyte colony-stimulating factor, or G-CSF. Sandoz is seeking approval for the same indication as the reference product.
February 10, 2016
14:32 EDTINCYNotable companies reporting before tomorrow's open
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11:21 EDTINCYIncyte rises after competitor drug put on hold by FDA
Shares of Incyte (INCY) are rising after a competitor's myelofibrosis drug was placed on full clinical hold by the FDA. WHAT'S NEW: CTI BioPharma (CTIC) announced Tuesday night that it received notice from the FDA that its Investigational New Drug Application for pacritinib had been placed on full clinical hold. Under the full clinical hold, all patients currently on pacritinib must discontinue the drug immediately and no patients can be enrolled or start pacritinib as initial or crossover treatment. CTI BioPharma withdrew its New Drug Application until the company has had a chance to review the safety and efficacy data from the PERSIST-2 Phase 3 clinical trial and decide next steps. Previously, on February 8, CTI BioPharma had announced the drug was on partial clinical hold. ANALYST REACTION: Leerink analyst Michael Schmidt said that while he didn't view CTI BioPharma's pacritinib as a significant threat to Incyte's Jakafi franchise in myelofibrosis, he believes the "surprising" setback of a potential competitor should remove a small overhang on Incyte shares. Leerink has an Outperform rating and $118 price target on Incyte shares. Meanwhile, CTI BioPharma was downgraded by analysts at Piper Jaffray, WallachBeth and Ladenburg. Among them, WallachBeth's Bob Ai downgraded CTI to Sell with a 0c price target, saying he sees no reason to hold the stock. PRICE ACTION: Shares of Incyte gained 3.4% to $74.71 in late morning trading, while shares of CTI BioPharma plunged 41% to 29c.
08:20 EDTINCYPacritinib hold an incremental positive for Incyte, says Leerink
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February 9, 2016
11:18 EDTNVSOptions with increasing call volume; CERS WYN NVS ZIOP PZM PI OC DB MLM
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February 8, 2016
09:38 EDTNVSCigna enters into outcomes-based contract with Novartis
Cigna (CI) has entered into an outcomes-based contract with the pharmaceutical company Novartis (NVS) for the drug Entresto, which was approved by the FDA for the treatment of heart failure with reduced ejection fraction. The pay-for-performance agreement ties the financial terms to how well the drug improves the relative health of Cigna's customers. The primary metric is reduction in the proportion of customers with heart failure hospitalizations. This agreement is effective for Cigna's commercial business. Entresto is a preferred brand subject to prior authorization review. The prior authorization process is part of utilization management to help control prescription drug costs and ensure coverage of the most appropriate drug therapies.
06:28 EDTNVSPharma trade group rolls out ad campaign aimed at lawmakers, WSJ says
The pharmaceutical industry is launching a new ad campaign with the intention of improving its reputation with lawmakers in an effort to lobby against drug price restrictions, the Wall Street Journal reports. The industry's biggest trade group the Pharmaceutical Research and Manufacturers of America, or PhRMA, says it plans to spend several million dollars this year, and 10% more than it spent last year, on digital, radio, and print advertisements that highlight the sector's role in developing new drugs and advancing medical science, the report says. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Reference Link
February 7, 2016
14:27 EDTNVSNovartis' somatic cell therapy receives orphan designation
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February 4, 2016
07:23 EDTNVSGSK will not be pressured into early consumer unit spinoff, Reuters says
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February 2, 2016
11:14 EDTNVSNovartis management to meet with Jefferies
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07:42 EDTNVSPressure mounts on big pharma names to shrink, sharpen focus, FT says
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January 29, 2016
07:53 EDTNVSNovartis management to meet with JPMorgan
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07:37 EDTNVSRadius Health should be bought aggressively at current prices, says Canaccord
Canaccord said they would be aggressive buyers of Radius Health (RDUS) especially at current share prices. The firm cited its partnership with Novartis (NVS), its drug pipeline, and expectations for an FDA filing of abaloparatide in the first quarter of 2016. Canaccord reiterated its Buy rating and $85 price target on Radius Health shares.
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