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August 12, 2014
07:15 EDTBCRX, TKMR, NNVC, GSKWHO 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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October 8, 2015
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12:20 EDTBCRXOn The Fly: Top stock stories at midday
Stocks on Wall Street were mixed at midday, with the Dow a bit higher, the S&P little changed and the Nasdaq lagging. The averages began the session uniformly in negative territory, but began to pare their losses almost immediately, then spent the rest of the morning teetering near the flat line. The tepid action is not surprising as investors await the release of the minutes from last month's FOMC rate setting meeting. ECONOMIC EVENTS: In the U.S., initial jobless claims dropped to 263,000 in the week ended October 3, versus expectations for 273,00 first-time claims. Investor attention is clearly focused on this afternoon's release of the FOMC minutes for the September 16-17 policy meeting, given the Fed's surprise decision to delay liftoff at that time. The minutes are scheduled to be released at 2 pm EDT. In Asia, markets were mixed, with Japan, Hong Kong, Taiwan and India all seeing some profit taking following days of strong gains, though mainland China re-opened for the first time since last Wednesday following the Golden Week holiday and saw a catch-up rally that pushed the Shanghai composite up about 3%. COMPANY NEWS: EMC (EMC) rose over 5.5% in early trading amid conflicting reports regarding M&A talks between the IT services and software company and Dell, which is privately owned by founder Michael Dell and private-equity partner Silver Lake. Last night, The Wall Street Journal reported that Dell and Silver Lake are in "advanced talks" to buy EMC, noting that one source indicated the deal being discussed calls for the buyers to spin off EMC's VMware (VMW) unit. Then, Re/code's Arik Hesseldahl reported that EMC has approached Dell in recent weeks about selling its VNX data storage business to the private technology company, but contended that acquiring a unit would make more logical and financial sense for Dell than buying all of EMC. However, CNBC's David Faber subsequently said, in keeping with the Journal, that Dell is in talks to acquire all of EMC for "above $27 per share," adding that a deal could be announced as soon as a week from now. Several analysts weighing in on the potential for a deal expressed doubt that a takeover of EMC by Dell is likely, but agreed that some alternate deal may make sense, adding that a potential Dell-EMC tie-up would be negative for HP Enterprise (HPQ)... Shares of eBay (EBAY) were among the worst performing on the S&P 500, sliding almost 8% near noon. The weakness in the online marketplace operator followed a report from e-commerce solutions and data provider ChannelAdvisor (ECOM), which estimated that eBay's same-store sales growth decelerated to 1.1% in September from August's 3.4% rate. In the same blog post, ChannelAdvisor reported that Amazon's (AMZN) same-store sales grew 19.2% in September, noting that was a decrease compared to August's 24.7% SSS growth rate. MAJOR MOVERS: Among the notable gainers was Tronox (TROX), which jumped 18.5% after Bloomberg reported that Apollo Global (APO) was mulling a takeover of Chemours (CC) as a potential first step in then consolidating titanium-dioxide makers. Shares of Chemours gained 7.5% following the report. Also higher were Polycom (PLCM) and Mitel (MITL), which gained 15% and 17%, respectively, after Elliott Management disclosed stakes in both companies and urged the two to consider a combination. Among the noteworthy losers was BioCryst (BCRX), which dropped 21% after the company said it completed patient enrollment in its clinical trial of orally-administered avoralstat in patients with hereditary angioedema, noting that without a deferral an NDA filing would occur in 2018. That NDA timing estimate was further out than prior comments from the company. Also lower was GoPro (GPRO), which fell 5.7% after Cleveland Research downgraded the stock to Neutral from Buy and lowered estimates below consensus to reflect deterioration in action camera shipments. INDEXES: Near midday, the Dow was up 25.75, or 0.15%, to 16,938.04, the Nasdaq was down 30.53, or 0.64%, to 4,760.62, and the S&P 500 was barely changed at 1,995.32.
10:56 EDTBCRXBioCryst weakess overdone, says JPMorgan
10:08 EDTBCRXHigh option volume stocks
High option volume stocks: BCRX RHI NBIX ZBH FMC JAKK GWW DPZ MXIM ROK
07:08 EDTGSKCodexis earns $6.5M milestone payment from GlaxoSmithKline
Codexis (CDXS) announced that it successfully completed Wave 2 of the transfer of its proprietary CodeEvolver protein engineering platform technology to GlaxoSmithKline (GSK) in Q3 of 2015. Codexis expects to receive a $6.5M payment from GSK for completion of this milestone in Q4. Codexis has received a $6M upfront payment and a $5M Wave 1 technology transfer milestone payment from GSK since announcing the technology collaboration and license agreement with GSK in July 2014. The agreement grants GSK a license to use Codexis' CodeEvolver platform technology to develop novel enzymes for use in the manufacture of GSK's pharmaceutical and health care products. The CodeEvolver platform technology has been installed and is operational at a GSK facility in Pennsylvania. Codexis is eligible to receive an additional $7.5M payment from GSK subject to the satisfactory completion of the final CodeEvolver technology transfer milestone. Codexis also has the potential to receive numerous additional contingent milestone payments under the agreement with GSK that range from $5.75M-$38.5M per project based on GSK's successful application of the licensed technology. In addition, Codexis will be eligible to receive royalties based on net sales, if any, of a limited set of products developed by GSK using Codexis' CodeEvolver protein engineering platform technology.
06:08 EDTBCRXBioCryst's candidate for hereditary angioedema meets all Phase 1 objectives
BioCryst's randomized, placebo-controlled, Phase 1 clinical trial of orally-administered BCX7353 in healthy volunteers met all of its objectives. The safety, tolerability, drug exposure and on-target plasma kallikrein inhibition results support advancing the development program into a Phase 2 study in hereditary angioedema patients. Oral BCX7353 was generally safe and well tolerated at all doses. No dose-limiting toxicity was identified. Daily dosing with BCX7353 strongly inhibited plasma kallikrein at all four dose levels. A Phase 2, four week dose ranging trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of BCX7353 as a preventative treatment to reduce the frequency of attacks in HAE patients is expected to begin by late 2015 or early 2016.
06:05 EDTBCRXBioCryst completes patient enrollment in OPus-2 trial of Avoralstat
BioCryst has completed enrollment in OPuS-2, a blinded, randomized, placebo-controlled clinical trial of orally-administered avoralstat in patients with hereditary angioedema. The trial designed to evaluate the efficacy and safety of two doses of avoralstat, 300 mg and 500 mg, administered three-times daily compared with placebo. The primary efficacy endpoint for the trial is the mean angioedema attack rate, which will be reported for each avoralstat dose group compared to placebo. BioCryst expects to report OPuS-2 results in early 2016. The results of this trial will be provided for regulatory discussions required for completion of avoralstat registration. The company plans to initiate a rat carcinogenicity study in early 2016. Without a deferral, NDA filing would occur in 2018.
06:03 EDTBCRXBioCryst to host conference call
Conference call to discuss the results of the BCX7353 Phase 1 trial and other aspects of BioCryst's HAE development program will be held on October 8 at 8:30 am. Webcast Link
October 6, 2015
13:32 EDTGSKBiotechs plummet with TPP seen as industry negative
Biotechs are falling intraday after reports that the Trans-Pacific Partnership, or TPP, has language that the exclusivity period for bioligics, or drugs derived from a biological sources, would be eight years, less than the twelve years it is currently in the United States. WHAT'S NOTABLE: In the U.S., biologics are protected from competition by follow-on products for twelve years from the time they are first granted marketing approval by the U.S. Food and Drug Administration, a protection that is distinct from patent protection. Recent reports on the TPP suggest that the protection will last five years with an additional safety monitoring period of up to three years before a biosimilar can be registered, which would effectively be an eight year exclusivity period. ANALYST REACTION: Piper Jaffray analyst Joshua Schimmer, however, said the development is a "step forward," especially since it does not overrule the 12 years' exclusivity for the drugs in the U.S. While the sector asked for twelve years' exclusivity to match the U.S., eight years is a "reasonable compromise," the analyst argued. His top picks were Alexion (ALXN), Celgene (CELG), and Amgen (AMGN) in the large-cap space, GW Pharmaceuticals (GWPH) and bluebird bio (BLUE) among mid-caps, and Flex Pharma (FLKS), Lion Biotechnologies (LBIO), Otonomy (OTIC), and Ignyta (RXDX) in the small-cap sector. Further, Schimmer stated that more names look "increasingly compelling" amid the selloff. NOTABLE DECLINERS: Alexion is lower by 2.53%, Celgene is down 4.32%, Amgen is declining 1.91%, Biogen (BIIB) is down 3.4%, and Gilead Sciences (GILD) is falling 2.22%. STOCKS TO WATCH: Other publicly traded companies in the pharmaceutical 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).
October 1, 2015
08:04 EDTGSKPfizer completes acquisition of Nimerix, Mencevax from GSK
Pfizer (PFE) announced that it has completed the acquisition of GlaxoSmithKline's (GSK) quadrivalent meningococcal ACWY vaccines Nimenrix and Mencevax.
September 30, 2015
12:41 EDTGSKGlaxoSmithKline exercises option for Liquidia Technologies' inhaled therapeutics
Liquidia Technologies announced that GlaxoSmithKline has exercised its option under a Collaboration and Option Agreement signed in 2012 to exclusively license the right to research, develop, and commercialize inhaled therapeutics derived from the company's proprietary PRINT technology. Through this collaboration, Liquidia and GSK will continue to work together with the goal of advancing inhaled therapeutics into clinical studies. According to the agreement signed in June 2012, Liquidia was granted an upfront payment comprised of cash and equity, R&D funding, and potential development milestones and royalties. As a result of the GSK decision to exercise the option, Liquidia will receive an option fee, continued R&D funding, and potential product-based development and regulatory milestone payments. Liquidia has also retained the ability to independently develop an inhaled treatment for a particular disease field.
September 28, 2015
07:52 EDTGSKIIR Holdings to hold a conference
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September 27, 2015
16:58 EDTGSKGlaxoSmithKline, Theravance report Phase 3 data on Anoro Ellipta for COPD
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September 24, 2015
11:24 EDTGSKGlaxoSmithKline receives positive CHMP opinion in Europe for Nucala
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05:24 EDTGSKGlaxoSmithKline and Theravance intend to file Relvar Ellipta for COPD in Japan
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