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Stock Market & Financial Investment News

News Breaks
March 7, 2014
14:18 EDTREGN, SNY, AMGN, PFE, NVS, RHHBYConcerns with PCSK9 class not seen with Regeneron drug, says Citigroup
Citigroup said its talks with Regeneron (REGN) indicate that the issues the FDA has noted with PCSK9 drugs have not arisen in the ongoing Phase 3 studies of Regeneron and Sanofi's (SNY) Alirocumab. Citi suspects the events described in filings by Regeneron and Sanofi might have been seen with PCSK9 inhibitors being developed by Amgen (AMGN), Pfizer (PFE), Novartis (NVS) or Roche (RHHBY). Citi also notes that neurocognitive side effects are known to be caused by statins and it is unclear whether the effects were seen with PCSK9 inhibitors when used alone or when combined with statins.
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July 17, 2014
05:29 EDTNVSNovartis reports Q2 Core EPS $1.34, consensus $1.42
Reports Q2 revenue $14.6B, consensus $14.81B. Reports continued pipeline progress with positive regulatory decisions and significant clinical trial data released in Q2.
July 16, 2014
11:23 EDTRHHBYRoche Alzheimer drug shows mixed results in trial, NYT says
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10:36 EDTPFETreasury calls on Congress to halt inversion deals
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09:27 EDTPFEPfizer to acquire InnoPharma for upfront cash payment of $225M
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09:03 EDTSNYSanofi held talks on mature drugs with Abbott, Mylan, PE firms, Reuters says
Sanofi (SNY) has shopped an $8.5B portfolio of mature drugs to Abbott (ABT), Mylan (MYL) and private equity firms, according to Reuters, citing an internal company document circulated by the CGT union. Sanofi is considering whether to sell, carve out or create a joint venture for the portfolio of about 200 drugs, but a Sanofi spokesman said no decision has yet been made, the report noted. Reference Link
07:59 EDTPFETreasury Secretary urges Congress to take action on tax inversions
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07:04 EDTPFEPfizer says primary endpoint met in Phase 3 study of BeneFIX
Pfizer announced the positive results of a Phase 3 study comparing a prophylaxis regimen of BeneFIX Coagulation Factor IX 100 IU/kg once-weekly to on-demand treatment in people with moderately severe to severe hemophilia B. The top-line results of the study showed that the primary study endpoint was met and hemophilia B patients taking once-weekly BeneFIX showed a statistically significant reduction in the annualized bleeding rate relative to on-demand treatment with BeneFIX. In the study, the median ABR value, a commonly used measure of efficacy for prophylaxis regimens in hemophilia, was 2.0 for the prophylaxis regimen, compared to 33.6 for the on-demand regimen, representing a 94% decrease in bleeding rates. The mean ABR value was 3.6 for the prophylaxis period, compared to 32.9 for the on-demand treatment, which represents a reduction of 89%. Study results also showed that prophylaxis treatment significantly reduced both spontaneous and traumatic ABR compared to on-demand treatment with BeneFIX. In addition to meeting the primary endpoint, the secondary study endpoints showed that none of the 1,254 prophylaxis infusions administered during the study were associated with a less than expected therapeutic effect occurrence, which was defined as a spontaneous bleed occurring within 48 hours of a prophylaxis infusion. These results are preliminary, top-line data and are subject to additional analyses. Complete results from this study will be submitted for presentation at upcoming medical congresses and submitted for publication in a peer-reviewed journal.
06:26 EDTRHHBYBristol-Myers lung cancer trials being underestimated, says Citigroup
After building a statistical model of Bristol-Myers' two critical registration trials for Opdivo in lung cancer, Citigroup believes the market is "materially" underestimating both Phase III trials. Citi says potential Opdivo FDA approval in 2015 in lung cancer would give Bristol-Myers an up to two year lead time versus Merck (MRK) and Roche (RHHBY). The firm estimates 2023 Opdivo revenue at $7B and reiterates a Buy rating on Bristol with a $60 price target.
July 15, 2014
10:56 EDTAMGNFed calls small cap social media, biotech valuations 'stretched'
The Board of Governors of the Federal Reserve in its Monetary Policy Report dated today said valuation metrics in "some sectors" appear substantially stretched, "particularly those for smaller firms in the social media and biotechnology industries, despite a notable downturn in equity prices for such firms early in the year." A later part in the document reads, "Equity valuations of smaller firms as well as social media and biotechnology firms appear to be stretched, with ratios of prices to forward earnings remaining high relative to historical norms." The specific targeting of sectors by the Fed seems to be having an impact on stocks in the social media and biotech spaces. Shares of Yelp (YELP) are down over 5% to $67.51, while Twitter (TWTR) and Facebook (FB) are each down 2%. Celgene (CELG) and Amgen (AMGN) are leading the biotech space lower with pullbacks of greater than 1%.
10:33 EDTAMGNFacebook, Twitter slip following cautious valuation comments from Fed
Shares of a number of companies in the social media and biotech industries moved lower following the circulation of cautious comments about their stock valuations that were included in the Federal Reserve's latest Monetary Policy Report. WHAT'S NEW: In the report, presented by the Board of Governors of the Federal Reserve and signed on behalf of the governors by Chair Janet Yellen, the central bank wrote that some broad equity price indexes have increased to all-time highs in nominal terms since the end of 2013, but that valuation measures for the overall market in early July were "generally at levels not far above their historical averages." However, the Fed's report also cautioned that valuation metrics in some sectors do appear substantially "stretched," particularly those for smaller firms in the social media and biotechnology industries, despite a notable downturn in equity prices for such firms early in the year. As support for its assessment, the Fed noted that ratios of prices to forward earnings for "smaller firms as well as social media and biotechnology firms" remain "high relative to historical norms." PRICE ACTION: Following the circulation of the comments in the Fed report, shares of Facebook (FB) are down 88c, or 1.3%, to $67.02, Twitter (TWTR) is down 24c, or 0.6%, to $38.07 and LinkedIn (LNKD), is down 21c, or 0.1%, to $159.57. Shares of some biotechnology companies including Celgene (CELG) and Amgen (AMGN) also ticked lower following the circulation of the comments from the Fed's report.
05:44 EDTNVSNovartis to license Google 'smart lens' technology
Novartis (NVS) announced that its eye care division Alcon has entered into an agreement with a division of Google (GOOG) to in-license its "smart lens" technology for all ocular medical uses. The agreement with Google[x], a team within Google that is devoted to finding new solutions to big global problems, provides Alcon with the opportunity to develop and commercialize Google's "smart lens" technology with the potential to transform eye care and further enhance Alcon's pipeline and global leadership in contact lenses and intraocular lenses. The transaction remains subject to anti-trust approvals. The agreement between Google and Alcon represents an important step for Novartis, across all of its divisions, to leverage technology to manage human diseases and conditions. Google's key advances in the miniaturization of electronics complement Novartis's deep pharmaceuticals and medical device expertise. Novartis aims to enhance the ways in which diseases are mapped within the body and ultimately prevented.
05:37 EDTRHHBYGenentech Avastin granted priority review by FDA
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05:35 EDTNVSNovartis collaborates with Banner Alzheimer's Institute on study
Novartis announced a collaboration with Banner Alzheimer's Institute, or BAI, on a pioneering clinical study in Alzheimer's disease, or AD, prevention. The study will determine whether two Novartis investigational anti-amyloid treatments can prevent or delay the emergence of symptoms of AD in people identified as being at genetic risk for developing the late-onset form of the disease. Using an innovative trial design, the two treatments will be given in cognitively healthy people at genetic risk of developing the build-up of amyloid protein in the brain that may eventually lead to AD. One treatment is an active immunotherapy, a treatment that stimulates an immune response, and triggers the production of natural antibodies against amyloid. This investigational treatment, given via an injection, is in phase II clinical development. The second treatment, a BACE inhibitor, is an oral medication about to enter phase I trials and is designed to prevent the production of different forms of amyloid.
July 14, 2014
11:20 EDTRHHBYExelixis seen as potential target for Roche, TheStreet says
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07:23 EDTNVSAlzheimer's Association to hold a conference
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July 10, 2014
15:43 EDTNVSNovartis siponimod designated as orphan treatment of dermatomyositis
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10:02 EDTRHHBYRoche unit, Merck KGaA to develop companion test for cancer treatment
Ventana Medical Systems, a member of the Roche Group (RHHBY), announced it has entered into an agreement with Merck KGaA (MKGAY), which operates as EMD Serono in the United States and Canada, to collaborate with Merck KGaA's biopharmaceutical division on the development and commercialization of a companion diagnostic for an undisclosed target using Ventana's proprietary diagnostic assays.
08:10 EDTAMGNMorgan Stanley's Vintage Values 2015 list selected
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July 9, 2014
17:02 EDTSNY, REGNRegeneron, Sanofi announce positive results from Phase 2b study of Dupilumab
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06:49 EDTPFEPfizer given dismissal of U.S. investor class action before trial, Reuters says
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