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Stock Market & Financial Investment News

News Breaks
August 12, 2014
07:15 EDTNNVC, GSK, BCRX, TKMRWHO says ethical to offer unproven interventions in light of Ebola outbreak
The World Health Organization issued a statement that read in part: "West Africa is experiencing the largest, most severe and most complex outbreak of Ebola virus disease in history. Ebola outbreaks can be contained using available interventions like early detection and isolation, contact tracing and monitoring, and adherence to rigorous procedures of infection control. However, a specific treatment or vaccine would be a potent asset to counter the virus...In the particular circumstances of this outbreak, and provided certain conditions are met, the panel reached consensus that it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention." Publicly traded companies that have confirmed development activities on Ebola treatments include Tekmira Pharmaceuticals (TKMR), GlaxoSmithKline (GSK), NanoViricides (NNVC) and BioCryst (BCRX). Reference Link
News For TKMR;GSK;NNVC;BCRX From The Last 14 Days
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February 8, 2016
14:06 EDTBCRXBioCryst downgraded to Hold from Buy at Needham
12:05 EDTBCRXOn The Fly: Top stock stories at midday
Stocks on Wall Street began the session deep in negative territory and proceeded to move lower throughout the session, amid a renewed selloff in oil prices and fears that bankruptcies related to the prolonged slump will begin to pick up pace. The move lower is not restricted to the energy sector and has been broad-based, as each of the major equity indexes was lower by about 2% or more. ECONOMIC EVENTS: In the U.S., the labor market conditions index came in at 0.4 for January, below expectations for a reading of 2.0. In Asia, markets in mainland China, Hong Kong, Taiwan and Korea were all closed for the New Year holiday. Data was still released in China that showed the country's foreign currency reserves fell to their lowest level since May 2012, dropping about $99B in January, though that was better than analysts forecast and ahead of some recent whispers. COMPANY NEWS: Chesapeake Energy (CHK) tumbled over 50%, dropping as low as $1.50 per share, after media reports indicated that the natural gas producer has hired restructuring lawyers from Kirkland & Ellis. Subsequently, the stock was halted pending news and the company confirmed that Kirkland & Ellis continues to advise the company as it seeks to further strengthen its balance sheet. However, Chesapeake noted that it currently has "no plans to pursue bankruptcy," and its shares recovered some of their earlier losses upon being reopened for trading. The stock was down a bit over 25% near noon... Meanwhile, another player in the oil space with ties to Chesapeake, Energy Transfer Equity (ETE), declined 30% after the company disclosed, via a regulatory filing after Friday's close, that it was making a change to the Chief Financial Officer of its general partner. According to the company, the departure of CFO Jamie Welch from the post was not caused by any disagreements between him and the MLP over accounting issues or financial matters. Williams Company (WMB), with has agreed to merge with Energy Transfer, also slid 25%. MAJOR MOVERS: Among the notable gainers was Apollo Education (APOL), which rallied 25% after it agreed to be acquired by a group led by private equity company Apollo Global (APO) for $9.50 per share. Also higher was GoPro (GPRO), which gained 9% after Microsoft (MSFT) announced a new collaborative patent licensing agreement with the beaten down action camera maker. Among the noteworthy losers was Sarepta (SRPT), which fell 12% after the FDA delayed a decision on the company's Duchenne muscular dystrophy treatment eteplirsen. Also lower was BioCryst (BCRX), which plunged 67% after a clinical trial of its hereditary angioedema drug failed to meet its primary endpoint. In addition, DexCom (DXCM) was 17% lower after it was downgraded to Neutral from Outperform at Baird. INDEXES: Near midday, the Dow was down 317.14, or 1.96%, to 15,887.83, the Nasdaq was down 101.02, or 2.32%, to 4,262.12, and the S&P 500 was down 36.43, or 1.94%, to 1,843.62.
11:08 EDTBCRXBioCryst downgraded to Neutral after avoralstat trial faiure at Piper Jaffray
As previously reported, Piper Jaffray analyst Charles Duncan downgraded BioCryst to Neutral from Overweight after avoralstat failed to meet its primary endpoint in a Phase 2 trial. The results were not entirely unexpected given prior management signals, Duncan told investors in a research note, but added that there is now limited visibility on the development plan for an oral kallikrein inhibitor in the next 6-12 months. The analyst cut his price target on BioCryst to $5 from $15.
11:02 EDTBCRXBioCryst downgraded to Neutral from Overweight at Piper Jaffray
10:06 EDTBCRXHigh option volume stocks
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09:55 EDTBCRXBioCryst plummets after hereditary angioedema drug disappoints in study
Shares of BioCryst Pharmaceuticals (BCRX) are plunging in morning trading after the biotechnology company reported disappointing clinical trial results for its potential hereditary angioedema treatment. WHAT'S NEW: Biocryst this morning announced results from its OPuS-2 trial evaluating avoralstat in treatment of patients with hereditary angioedema, or HAE. BioCryst said either a 500 mg or 300 mg dose of the drug was administered three times daily to patients suffering HAE attacks, but said those patients did not have a lower rate of edema, or swelling, than patients given a placebo. The primary goals of the study were to characterize the efficacy of avoralstat in reducing the frequency of angioedema attacks and to evaluate the safety and tolerability of 12 weeks of avoralstat treatment. The primary efficacy endpoint of the study was angioedema attack frequency, with secondary endpoints including quality of life, attack duration and attack severity. EXECUTIVE COMMENTARY: President and Chief Executive Officer Jon Stonehouse said that the OPuS-2 trial was a "well-designed and executed trial that gave us a clear answer; this dosage form of avoralstat is not a viable formulation to move forward." Stonehouse also commented that "While we are disappointed in the study results, we learned that meaningfully better exposure is needed for avoralstat to succeed. We expect results from a relative bioavailability study testing a novel solid dosage form of avoralstat by mid-year -- the primary goals of this study are to achieve much higher exposures and twice daily dosing." He said that the company's other opportunity to achieve higher exposure of an oral kallikrein inhibitor is with BCX7353 and the company expects results from the BCX7353 APeX-1 dose ranging study in HAE patients by year end. PRICE ACTION: In morning trading, BioCryst dove 66% to $2.10.
09:17 EDTBCRXOn 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.
08:10 EDTGSKOncoMed: FDA says PINNACLE trial should continue under supervision
Following notification of the ALPINE DSMB's findings, OncoMed (OMED) initiated interactions with tarextumab clinical investigators, partner GlaxoSmithKline (GSK), the FDA and the PINNACLE trial's DSMB chairperson to assess potential impact of these results on the overall development program, including the ongoing Phase 2 PINNACLE trial in small-cell lung cancer patients. PINNACLE trial investigators received an addendum to the informed consent form that included a description of the interim analysis from ALPINE. The FDA and the PINNACLE DSMB were provided unblinded data from both Phase 2 trials, a description of OncoMed's exploratory analysis of the ALPINE results and related trial materials for review. The independent analyses of the FDA and PINNACLE DSMB indicated that the PINNACLE trial could continue under the supervision of the PINNACLE DSMB monitoring for safety and efficacy and that appropriate safeguards are in place. OncoMed is conducting the PINNACLE Phase 1b/2 clinical trial of tarextumab for the treatment of small cell lung cancer. The randomized Phase 2 trial is comparing progression-free survival outcomes for patients treated with tarextumab administered at 15 mg/kg every three weeks in combination with etoposide and cisplatin or carboplatin versus patients who receive placebo plus chemotherapy. Additionally, PFS will be assessed using a predictive biomarker for high tumor Notch3 expression. Secondary endpoints for the Phase 2 study include overall survival, overall response rate, pharmacokinetics, safety and other biomarkers. The PINNACLE study is being conducted at about 40 sites in the U.S. and is expected to enroll approximately 130 patients. Results from the Phase 2 PINNACLE trial are anticipated in 2017.
07:03 EDTGSKBiogen joins Centre for Therapeutic Target Validation
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06:28 EDTGSKPharma 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
06:09 EDTBCRXBioCryst to host conference call
Conference call to discuss the OPuS-2 trial results and other aspects of BioCryst's HAE development program will be held on February 8 at 8am. Webcast Link
06:07 EDTBCRXBioCryst reports OpuS-2 clinical trial results
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February 4, 2016
07:23 EDTGSKGSK will not be pressured into early consumer unit spinoff, Reuters says
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February 3, 2016
07:23 EDTGSKGlaxoSmithKline confirms 2015 ordinary dividend of 80p, special dividend of 20p
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07:23 EDTGSKGlaxoSmithKline sees double digits CER FY16 core EPS percentage growth
If FX rates held at January average levels estimated impact of +5% on 2016 Sterling core EPS growth.
07:21 EDTGSKGlaxoSmithKline reports Q4 EPS (7.3p) vs. 21.5p last year
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February 2, 2016
08:17 EDTGSKAdaptimmune, GSK expand strategic immunotherapy collaboration
Adaptimmune Therapeutics (ADAP) and GlaxoSmithKline (GSK) announced that the companies have expanded the terms of their strategic collaboration agreement to accelerate Adaptimmune's lead clinical cancer program, an affinity enhanced T-cell immunotherapy targeting NY-ESO-1, toward pivotal trials in synovial sarcoma. Adaptimmune and GSK announced a strategic collaboration and licensing agreement in June 2014 for up to five programs, including the lead NY-ESO TCR program. GSK has an option on the NY-ESO-1 program through clinical proof of concept and, on exercise, will assume full responsibility for the program.
07:42 EDTGSKPressure mounts on big pharma names to shrink, sharpen focus, FT says
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06:32 EDTGSKGSK, J&J back Index Ventures' $1B biotech business spinoff, Reuters says
GlaxoSmithKline (GSK) and Johnson & Johnson (JNJ) will back a new spinoff from Index Ventures, which is spinning off its biotech portfolio into a new $1B entity, Reuters reports. The New Medicxi Ventures business will be helmed by the existing life sciences team from Index and will include all the current biotech portfolio firms, the report says. Medicxi raises $229M for a new fund in Europe with GSK and J&J each putting in 25%, Reuters reports. Reference Link
February 1, 2016
07:12 EDTNNVCNanoViricides signs agreement with University of Wisconsin
NanoViricides announced that it has entered into an agreement with the University of Wisconsin for the evaluation of its nanoviricides drug candidates in models of ocular herpes virus infections. The studies will be performed in the laboratory of Dr. Curtis Brandt, an expert in herpes simplex virus infections and in evaluating anti-viral agents. The Company has previously reported the successes of its nanoviricides drug candidates in pre-clinical studies of dermal herpes virus infections in mouse models. The studies in Dr. Brandt's laboratory will be critical in optimizing its anti-herpes drug candidates against ocular herpes virus infections. The goal of these studies will be to identify a drug development candidate as a treatment for ocular keratitis in humans caused by herpes simplex virus infections.
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