MARKET CURRENTS
real-time news and commentary for investors
MARKET CURRENTS
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Today - Tuesday, May 21, 2013
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Monday, May 20, 2013
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5:23 PM Pfizer (PFE) says it's discontinuing Phase 3 studies on its investigational compound inotuzumab ozogamicin in combination with rituximab, a treatment for patients with non-Hodgkin lymphoma who are not candidates for intensive high-dose chemotherapy, after the study failed to meet its primary objective of improving overall survival. No new or unexpected safety issues were identified, and PFE says it's continuing to review the the drug for potential subset applications. Shares -0.3% AH. Comment!
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4:14 PM Ironwood Pharmaceuticals (IRWD) announces a 10.5M share public offering, with a 30-day option to purchase up to an additional 1,575,000 shares. All of the shares are being offered by the company, which plans to use the proceeds to support the commercial launch of Linzess in the U.S. and to fund linaclotide development opportunities to strengthen the clinical profile of the drug and expand the product label for additional populations and indications. Shares +0.7% AH. 1 Comment
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4:09 PM Affymetrix (AFFX +1.4%) finishes higher after earlier appointing Gavin Wood to the position of Chief Financial Officer. Mr. Wood joined AFFX in 2006, having served most recently as VP Finance, International Controller based in the United Kingdom. Tim Barabe, the current CFO, is expected to retire effective June 28, 2013. Comment!
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3:40 PM Intercept Pharmaceuticals (ICPT +2.3%) gains after presenting positive results from ongoing Phase 2a trials of its treatment for primary bile acid diarrhea with obeticholic acid at the Digestive Diseases Week Conference. The initial results demonstrate that treatment with the acid is associated with statistically significant increased levels of fibroblast growth factor 19 and improvement in clinical symptoms in patients with PBAD. Comment!
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3:37 PM Cubist Pharmaceuticals (CBST +11.3%) spikes to session highs. The move appears relates to an apparent Markman ruling on Hospira (HSP +0.7%, which has a generic version of Cubist's drug Cubicin. Seeking Alpha contributor PropThink noted last week that the ruling would likely be a 'clearing event' for the company. Comment!
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2:35 PM NanoString files for an $86.25M IPO. The company, which focuses on the development of genomic information from minute amounts of tissue for cancer research, plans to list on the Nasdaq Global Market under the ticker, "NSTG." The offering is being made through JP Morgan, Morgan Stanley, Leerink Swann, and Baird. Comment!
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2:17 PM Covidien (COV -0.1%) says its Nellcor pulse oximetry portfolio has received FDA 501(k) clearance for motion claims. COV is the first company of its kind to receive the FDA stamp of approval for a motion-tolerant bedside device that's also compliant with the International Organization for Standardization standards for pulse oximetry. Comment!
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2:04 PM Natus Medical (BABY -1.1%) slips after its Q1 beats estimates, but the the company forecast the current quarter to come in at the low end of expectations. For Q2, it now expects to report revenue of $86M to $90M and and an EPS of $0.17 to $0.20. The Street is looking for $90M in revenue and $0.19 per share, respectively. For the full year, the company anticipates revenue of $362M to $367M and an EPS of $0.85 to $0.88. Comment!
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1:42 PM Elan's (ELN +3.3%) board responds in boilerplate fashion to Royalty Pharma's sweetened offer to acquire the company, saying it will, as before, in line with its obligations under Irish Takeover law, assess the bid and advise its shareholders accordingly. In the meantime, ELN shareholders are strongly advised to take no action. Comment!
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1:37 PM More on Royalty Pharma/ Elan (ELN +3.3%): Royalty says ELN "dramatically overpaid" for its 21% participation interest in future royalty payments from Theravance's (THRX -5.9%) respiratory collaborations with GlaxoSmithKline (GSK +0.2%). The deal was made in a "hasty" fashion Royalty claims, and says the same might well be said of ELN's purchases of AOP Oprhan Pharmaceuticals and a 48% stake in NewBridge Pharmaceuticals (for a combined cost of $380M). The new offer ($12.50/share) is contingent upon shareholders voting against the THRX deal. Comment!
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12:34 PM AbbVie (ABBV -1%) says it's initiated a Phase 3 clinical study of diabetic nephropathy with Atrasentan, which is designed to assess the effects of the investigational compound on progression of kidney disease as part of standard of care for patients with stage 2 to 4 chronic kidney disease and type 2 diabetes. The study will evaluate the drug's impact on renal outcomes, such as the onset of end-stage renal disease, as defined by need for chronic dialysis, transplant or death due to renal failure progression. Comment!
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12:31 PM Acorda Therapeutics (ACOR -1%) is issued a patent for Amprya entitled "Methods of Using Sustained Release Aminopyridine Compositions." This patent covers a range of dosage strengths, and is separate from 2 method of use patents issued in 2011 and 2013 that are set to expire in 2027 and 2026, respectively. The drug is approved in the United States as a treatment to improve walking in patients with multiple sclerosis. Comment!
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11:48 AM Edap (EDAP +5.3%) posts solid gains after saying minimally invasive, high-intensity focused ultrasound (HIFU) therapy demonstrates "encouraging cancer-specific survival rates in patients with localized prostate cancer." The company cites data culled from a large, long-term study of "mobility and oncologic outcomes" conducted by two doctors at Edouard Herriot Hospital in France. (PR) Comment!
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11:04 AM Sangamo BioSciences (SGMO -4.5%) takes a bit of a hit this morning, despite the presentation of new data demonstrating the successful application of its In Vivo Protein Replacement Platform in a mouse model. The company, in partnership with Shire (SHPG +1.8%), is developing ZFP Therapeutics for both hemophilia A and B using this approach. The data was presented late last week at the 16th Annual Meeting of the American Society of Gene and Cell Therapy in Salt Lake City. 2 Comments
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8:50 AM Given Imaging (GIVN) rises 2.34% premarket after saying several studies presented at Digestive Disease Week highlight the value of the company's SmartPill for the "evaluation and diagnosis of different motility conditions." The studies suggest "an expanded role" for the device, the company says. (PR) Comment!
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8:04 AM Xenoport (XNPT) plummets 19.26% premarket after saying data from a Phase 3 clinical trial of arbaclofen placarbil did not demonstrate that the treatment provides statistically significant improvement versus a placebo in patients with spasticity due to multiple sclerosis. The company will "terminate further investment in the program." (PR) Comment!
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7:54 AM The FDA grants Synageva BioPharma (GEVA) Breakthrough Therapy designation for sebelipase alfa, a treatment for early onset acid lipase deficiency. Earlier this month, JPMorgan expressed some skepticism based on what the bank says is a fairly low level of disease awareness (even among specialists). (PR) Comment!
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