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Stock Market & Financial Investment News

News For NTE;CTIC;NIHD;IMOS;EXEL From The Last 14 Days
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February 10, 2016
11:21 EDTCTICIncyte 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.
10:01 EDTCTICOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: Antero Resources (AR) downgraded to Neutral from Buy at Goldman... Apollo Investment (AINV) downgraded to Sell from Neutral at Citi... BBA Aviation (BBAVY) downgraded to Neutral from Buy at Goldman... CM Finance (CMFN) downgraded to Outperform from Strong Buy at Raymond James... CTI BioPharma (CTIC) downgraded to Sell from Hold at WallachBeth... Calix (CALX) downgraded to Market Perform from Outperform at Cowen... ConocoPhillips (COP) downgraded to Peer Perform from Outperform at Wolfe Research... Fifth Street Finance (FSC) downgraded to Neutral from Overweight at JPMorgan... Fortis (FRTSF) downgraded to Neutral from Outperform at Credit Suisse... ITC Holdings (ITC) downgraded to Market Perform from Outperform at Wells Fargo... KapStone (KS) downgraded to Hold from Buy at Deutsche Bank... Knight Transportation (KNX) downgraded to Hold from Buy at Evercore ISI... Lake Shore Gold (LSG) downgraded to Sector Performer from Outperformer at CIBC... Medley Capital (MCC) downgraded to Hold from Buy at Jefferies... Pandora (P) downgraded to Market Perform from Outperform at Cowen... Parker-Hannifin (PH) downgraded to Hold from Buy at Evercore ISI... Parkway Properties (PKY) downgraded on real estate headwinds, valuation at Stifel... Plains GP Holdings (PAGP) downgraded to Neutral from Outperform at Credit Suisse... Ruckus Wireless (RKUS) downgraded to Neutral from Buy at SunTrust... SolarCity (SCTY) downgraded to Neutral from Buy at Roth Capital... Tahoe Resources (TAHO) downgraded to Sector Perform from Outperform at RBC Capital... USANA (USNA) downgraded to Neutral from Buy at DA Davidson... Valero (VLO) downgraded to Buy from Conviction Buy at Goldman... Western Union (WU) downgraded to Neutral from Outperform at Macquarie... XL Group (XL) downgraded to Sell from Hold at Deutsche Bank.
09:19 EDTCTICOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Akamai (AKAM), up 16.5%... Prospect Capital (PSEC), up 10.7%... Panera Bread (PNRA), up 2%. ALSO HIGHER: Deutsche Bank (DB), up 6.1% after the Financial Times reported that the company is considering a multibillion bond buyback... Fitbit (FIT), up 3.7% after Marc Benioff reported a 5% stake in the company... FireEye (FEYE), up 3.9% after being upgraded to Buy from Neutral at BTIG... Shire (SHPG), up 1.7% after being upgraded to Outperform from Sector Perform at RBC Capital. DOWN AFTER EARNINGS: Time Warner (TWX), down 7.6%... Disney (DIS), down 5.1%... SolarCity (SCTY), down 27.8%. ALSO LOWER: CTI BioPharma (CTIC), down 38% after the FDA placed pacritinib IND on full clinical hold... Mast Therapeutics (MSTX), down 40.1% after 29.1M share Spot Unit offering priced at $0.275.
09:16 EDTCTICCTI BioPharma downgraded to Neutral from Buy at Ladenburg
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08:20 EDTCTICPacritinib hold an incremental positive for Incyte, says Leerink
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06:47 EDTCTICCTI BioPharma downgraded to Sell from Hold at WallachBeth
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05:58 EDTCTICCTI BioPharma downgraded to Neutral from Overweight at Piper Jaffray
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05:17 EDTCTICCTI BioPharma says FDA placed pacritinib IND on full clinical hold
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February 8, 2016
09:17 EDTCTICOn The Fly: Pre-market Movers
HIGHER: Apollo Education (APOL), up 26.6% after announcing that it will be acquired for $9.50 per share... Sprouts Farmers Market (SFM), up 5% after being added to S&P 400... GoPro (GPRO), up 3.4% after signing a licensing agreement with Microsoft (MSFT). LOWER: BioCryst Pharmaceuticals (BCRX), down 60.9% after reporting OpuS-2 clinical trial results... CTI BioPharma (CTIC), down 55.4% after the FDA placed a partial clinical hold on pacritinib studies... Tableau (DATA), down 5.5% after being downgraded to Equal Weight at Morgan Stanley... HSBC (HSBC), down 3.6% after being downgraded to Underweight from Equal Weight at Morgan Stanley... Chesapeake Energy (CHK), down 21% after Hedgeye analyst Kevin Kaiser said in an interview with Barron's that Chesapeake could go to zero... Twitter (TWTR), down 2.9% after backlash over its new algorithmic timeline.
05:25 EDTCTICCTI BioPharma completes enrollment in PERSIST-2 Phase 3 clinical trial
CTI BioPharma announced that as of February 3, it has completed patient enrollment in the PERSIST-2 Phase 3 clinical trial of pacritinib for the treatment of patients with myelofibrosis. PERSIST-2 is evaluating pacritinib for patients with myelofibrosis whose platelet counts are less than or equal to 100,000 per microliter. Under the FDA partial clinical hold referenced above, patients currently receiving pacritinib may continue to do so unless they are not deriving benefit after 30 weeks of pacritinib treatment, and crossover of patients from the control arm to the pacritinib arm will not be allowed.
05:24 EDTCTICCTI BioPharma says FDA places partial clinical hold on pacritinib studies
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February 4, 2016
07:18 EDTIMOSChipMOS announces NT$600M repurchase program
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February 2, 2016
11:39 EDTIMOSOptions with increasing call volume; FDC IMOS WEN IDTI HS GPR KORS HRS PNRA R CX
February 1, 2016
08:07 EDTEXELExelixis announces positive overall survival results from Meteor trial
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January 28, 2016
16:17 EDTEXELExelixis announces EMA acceptance of MAA for cabozantinib
Exelixis announced the European Medicines Agency, or EMA, has accepted for review the Marketing Authorization Application, or MAA, for cabozantinib as a treatment for patients with advanced renal cell carcinoma, or RCC, who have received one prior therapy. The completion of the MAA validation process confirms that the submission is sufficient to permit a substantive review for marketing authorization in the European Union. The EMA's Committee for Medicinal Products for Human Use, or CHMP, previously granted accelerated assessment to cabozantinib for advanced RCC. As a result, the MAA will be eligible for a 150-day review, versus the standard 210 days.
09:19 EDTEXELOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Facebook (FB), up 13.9%... Under Armour (UA), up 14.6%... MicroStrategy (MSTR), up 8.9%... Harley-Davidson (HOG), up 8%... Paypal (PYPL), up 6%... Mellanox (MLNX), up 7.9%... Cirrus Logic (CRUS), up 6.2%... Alibaba (BABA), up 4.5%. ALSO HIGHER: Neos Therapeutics (NEOS), up 61.4% after the FDA approved Adzenys XR-ODT for the treatment of ADHD... Exelixis (EXEL), up 4.7% after the U.S. FDA determined the company's New Drug Application for cabozantinib is sufficiently complete... Kinder Morgan (KMI), up 6.7% after being upgraded at Credit Suisse and Stifel. DOWN AFTER EARNINGS: OSI Systems (OSIS), down 21.3%... ServiceNow (NOW), down 22.3%... eBay (EBAY), down 11.5%... InvenSense (INVN), down 10.5%... Juniper Networks (JNPR), down 9.3%... Hologic (HOLX), down 4.4%... Abbott Laboratories (ABT), down 3.6%... Potash (POT), down 2.1%... Qualcomm (QCOM), down 3.6%.
08:03 EDTEXELExelixis: FDA deems NDA for cabozantinib as 'sufficiently complete'
Exelixis announced that the U.S. FDA has determined the company's New Drug Application for cabozantinib as a treatment for patients with advanced renal cell carcinoma who have received one prior therapy to be sufficiently complete to permit a substantive review. The NDA will be considered officially filed 60 days from the date of the completion of the submission, or February 20, 2016. The FDA granted Priority Review to the filing and assigned a Prescription Drug User Fee Act action date of June 22, 2016. "With FDA granting Priority Review to our application, Exelixis is one step closer to offering physicians cabozantinib as an important new therapeutic option for their patients with advanced renal cell carcinoma," said Michael M. Morrissey, Ph.D., president and CEO of Exelixis. "While we work closely with the FDA during the review process, Exelixis will continue to execute on our commercial plans, including our commitment to be ready for a potential launch by April 1st of this year." A Priority Review designation is granted by the FDA for drugs that, if approved, would be significant improvements in the treatment, prevention or diagnosis of a disease. Previously, the FDA granted cabozantinib Breakthrough Therapy designation and Fast Track designation for the compound's proposed RCC indication. The NDA is based on the results of METEOR, a phase 3 pivotal trial comparing cabozantinib to everolimus in patients with advanced RCC who experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor. In July 2015, Exelixis announced top-line results demonstrating that the trial had met its primary endpoint of improving progression-free survival; compared with everolimus, cabozantinib was associated with a 42% reduction in the rate of disease progression or death. These data were later presented at the European Cancer Congress in September 2015 and concurrently published in The New England Journal of Medicine.

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