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News Breaks
March 28, 2014
07:39 EDTCYTK, AMGNCytokinetics announces opening to enrollment of COSMIC-HF expansion
Cytokinetics (CYTK) announced that the expansion phase of the Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure, or COSMIC-HF, has opened to enrollment. COSMIC-HF is a Phase II double-blind, randomized, placebo-controlled, multicenter clinical trial designed to assess the pharmacokinetics and tolerability of omecamtiv mecarbil dosing orally in patients with heart failure and left ventricular systolic dysfunction. The expansion phase of COSMIC-HF will enroll approximately 450 patients randomized 1:1:1 to receive placebo, 25 mg, or 50 mg twice daily of omecamtiv mecarbil. Escalation to the 50 mg dose will depend on the plasma concentration of omecamtiv mecarbil following two weeks of oral dosing at 25 mg twice daily. The primary objective of the expansion phase of this trial is to characterize the safety, tolerability, and pharmacokinetics of omecamtiv mecarbil dosed orally during 20 weeks of treatment. The secondary objectives are to assess the changes from baseline in systolic ejection time, stroke volume, left ventricular end-systolic diameter, left ventricular end-diastolic diameter, heart rate and N-terminal pro-brain natriuretic peptide during 20 weeks of treatment. The expansion phase of COSMIC-HF is expected to enroll heart failure patients from approximately 100 clinical sites internationally. COSMIC-HF is being conducted by Amgen (AMGN) in collaboration with Cytokinetics. Amgen holds an exclusive, worldwide license to develop and commercialize omecamtiv mecarbil and related compounds, subject to Cytokinetics' specified development and commercialization participation rights.
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July 17, 2014
16:10 EDTAMGNAmgen announces positive Phase 3 results for AMG 416
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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.
July 10, 2014
08:10 EDTAMGNMorgan Stanley's Vintage Values 2015 list selected
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07:37 EDTCYTKCytokinetics announces additional results relating to Tirasemtiv
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