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February 4, 2014
19:03 EDTAGEN, IDIX, ARWR, HAIN, OCLR, IDRA, CHRW, GNW, MYGN, MMMOn The Fly: After Hours Movers
UP AFTER EARNINGS: Myriad Genetics (MYGN), up 14.5%... Genworth (GNW), up 5%... Oclaro (OCLR), up 5.6%. ALSO HIGHER: 3M (MMM), up 2% after the Dow member announced a $12B share repurchase plan... Idenix Pharmaceuticals (IDIX), up 7.3% after investment firm Baupost Group raised its stake in the company to more than 35% from roughly 27% and disclosed it was granted observer rights for meetings of Idenix's board and committees. DOWN AFTER EARNINGS: C.H. Robinson (CHRW), down 6.4%... Hain Celestial (HAIN), down 7.9%. ALSO LOWER: Agenus (AGEN), down 6.2% after announcing a public offering of common stock... Idera Pharmaceuticals (IDRA), down 3.8% after filing to sell common stock and warrants... Arrowhead Research (ARWR), down 3% after reporting a larger-than-expected quarterly loss and filing a $200M mixed securities shelf.
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November 27, 2015
10:44 EDTMYGNCMS may have made mistake with Myriad BRCA pricing, says Piper Jaffray
Piper Jaffray analyst William Quirk noted that the Centers for Medicare and Medicaid Services, or CMS, released the final 2016 Clinical Diagnostic Laboratory Fee Schedule yesterday, which showed Myriad Genetics' BRCA1/2 sequencing and full duplication/deletion analysis priced at $1,839.54, down from the $2,483.37 listed in the preliminary and final CLFS determination documents. Quirk said this may be an error and that he anticipates CMS to issue a correction and/or Myriad to file an appeal in the near-term. The analyst keeps an Overweight rating on Myriad shares.
November 23, 2015
08:08 EDTIDRAIdera Pharmaceuticals announces partnership with GSK
Idera Pharmaceuticals (IDRA) announced it has entered into an exclusive worldwide collaboration and license agreement with GSK (GSK) to research, develop and commercialize selected molecules from Idera's 3rd generation antisense platform for the treatment of selected targets in renal disease. Under the terms of the agreement, Idera is eligible to receive approximately $100M in development and regulatory milestone payments, including a $2.5M upfront payment. Additionally, Idera is eligible to receive royalties on all sales upon commercialization at varying rates up to five percent on annual net sales in excess of $500M.
05:36 EDTMYGNGenomic Health upgraded to Buy from Neutral at UBS
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November 20, 2015
16:09 EDTAGENAgenus files to sell 7.76M shares of common stock for holders
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November 19, 2015
08:46 EDTAGENAgenus to host research and development update
Research and Development Update to be held in New York on November 19 at 4 pm. Webcast Link
07:30 EDTMMMUBS to hold a conference
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07:19 EDTMYGNCMS decision a big positive for Myriad Genetics, says Stephens
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November 18, 2015
09:49 EDTMYGNCMS reversal removes 'huge overhang' for CareDx, says Mizuho
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09:06 EDTHAINHain Celestial weakness looks overdone, says Bernstein
Bernstein notes that Hain Celestial (HAIN) is now trading at a lower valuation than a number of "ostensibly more challenged food companies like" Kellogg (K) and General Mills (GIS). The firm expects the company to benefit over the longer term from current food trends. It trimmed its price target on the name to $50 from $60 and keeps an Outperform rating.
08:37 EDTIDRAIdera Pharmaceuticals appoints Joanna Horobin as Chief Medical Officer
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November 17, 2015
10:00 EDTGNWOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Antero Resources (AR) initiated with a Buy at Goldman... Applied Micro Circuits (AMCC) initiated with a Buy at Drexel Hamilton... Arc Logistics (ARCX) initiated with a Buy at DA Davidson... CNO Financial (CNO) initiated with a Buy at Goldman... Capstone Turbine (CPST) initiated with a Perform at Oppenheimer... Dominion (D) initiated with an Outperform at Scotia Howard Weil... Duke Energy (DUK) initiated with a Sector Perform at Scotia Howard Weil... EQT Corporation (EQT) initiated with a Neutral at Goldman... EverBank (EVER) initiated with a Hold at Sandler O'Neill... Exelon (EXC) initiated with a Sector Perform at Scotia Howard Weil... First Data (FDC) initiated with a Neutral at BTIG... Genworth (GNW) initiated with a Neutral at Goldman... Marinus Pharmaceuticals (MRNS) initiated with a Buy at Jefferies... New Relic (NEWR) initiated with a Buy at Needham... NextEra Energy Partners (NEP) initiated with a Sector Perform at Scotia Howard Weil... NextEra Energy (NEE) initiated with an Outperform at Scotia Howard Weil... PG&E (PCG) initiated with a Neutral at Citi... Reinsurance Group (RGA) initiated with a Sell at Goldman... The Advisory Board (ABCO) initiated with an Overweight at JPMorgan... Torchmark (TMK) initiated with a Neutral at Goldman... Ubisoft Entertainment (UBSFY) initiated with a Buy at Jefferies.
06:40 EDTGNWGenworth initiated with a Neutral at Goldman
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November 16, 2015
19:57 EDTOCLROclaro management to meet with Northland
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11:09 EDTARWRArrowhead says data shows ARC-520 can produce reductions of HBV antigens
Arrowhead Research Corporation presented data from a Phase 2a clinical study at The AASLD Liver Meeting 2015 demonstrating that ARC-520, its lead drug candidate against chronic hepatitis B infection, effectively reduced HBV viral antigens derived from cccDNA. HBV surface antigen was reduced substantially with a maximum reduction of 1.9 logs and a mean maximum reduction of 1.5 logs in treatment naive e-antigen-positive patients. This direct antiviral effect was still evident 57 days after a single dose. These data strongly support advancement of ARC-520, and Arrowhead has initiated multiple studies aimed at producing a functional cure of HBV. In this presentation, Dr. Yuen and co-authors show that in the Heparc-2001 clinical study, ARC-520 in combination with entecavir achieved maximum reductions of HBsAg, HBV DNA, HBeAg, and core-related antigen of 1.9 logs, 4.3 logs, 1.7 logs, and 1.2 logs, respectively. Consistent with findings from Arrowhead's chimpanzee study, also presented at AASLD, variations in viral antigen reduction indicated that patients previously treated with chronic entecavir and patients that were treatment-naive and negative for HBeAg likely had lower levels of cccDNA derived mRNA transcripts. As such, HBeAg-positive treatment naive patients experienced a greater relative reduction in HBsAg than patients that were HBeAg-negative or treatment experienced. One transitional patient in cohort 7 was HBeAg-positive at baseline and became HBeAg-negative at days 3 to 43. This patient experienced an intermediate response initially, however HBsAg continued to trend downward through day 57, the last time-point available. ARC-520 was well tolerated with no serious adverse events, no dose limiting toxicities, no discontinuations due to medication AEs, and a modest occurrence rate of AEs that were all deemed unrelated to study drug by the principal investigator. No AE occurred more than once. There were no AEs amongst 10 patients receiving placebo. There was a low occurrence rate of abnormal laboratory tests, with no observed relationship to timing or dose.
08:27 EDTARWRArrowhead to hold an analyst and investor reception
Management hosts an Analyst and Investor Reception to discuss ARC-520 and key data presented at the 66th Annual Meeting of AASLD in San Francisco on November 16 at 9:30 pm. Webcast Link
November 15, 2015
18:28 EDTARWRArrowhead reports data on anti-hepatitis B effects of ARC-520 in chimpanzees
Arrowhead announced the presentation of data demonstrating that ARC-520, its drug candidate against chronic hepatitis B infection, leads to "robust, sustained anti-viral effects in chimpanzees with chronic HBV," according to the company. Arrowhead also reported a new discovery that HBV DNA integrated into the host genome is "likely an important source of HBV surface antigen production, particularly in chimps that are negative for hepatitis B e-antigen." ARC-520 led to a drop in circulating HBsAg, with the degree of HBsAg reduction correlating with HBeAg status. HBeAg-positive and negative chimps demonstrated HBsAg reductions of 96.8%-99.8% and 68.4%-87.4%, respectively, with an intermediate response in a chimp transitioning from HBeAg positive to negative. In addition, one chimp seroconverted for HBeAg during ARC-520 therapy and had a sustained virologic response with respect to HBeAg, HBV DNA, and HBsAg. This persisted off therapy and through at least 32 weeks after ARC-520 and NUC therapy was removed. A second chimp demonstrated effects consistent with immunologic reactivation. Arrowhead also found that the predominant form of liver HBV DNA differed in HBeAg-negative versus HBeAg-positive chimps. Most HBV DNA in HBeAg-positive chimps was cccDNA, while less than 5% of HBV DNA in HBeAg-negative chimps was cccDNA. In addition, HBV RNA profiles in HBeAg-negative chimps were consistent with transcripts arising from integrated DNA. "These data and others, strongly suggest that integrated DNA is likely an important source of HBsAg production in HBeAg-negative chimps," claimed the company. "Direct confirmatory data" was obtained by treating HBeAg negative chimps with a siRNA designed to target transcripts originating from integrated HBV DNA. Up to an additional 99% of HBsAg knockdown was achieved, resulting in overall relative knockdown levels similar to those observed using ARC-520 in HBeAg-positive chimps. Arrowhead said it has incorporated one of these RNAi triggers and one targeting predominantly cccDNA derived transcripts into a new complementary drug candidate, ARC-521, that is planned to be in clinical trials in 2016. The company noted it plans to present additional data at the Hep Dart conference in December demonstrating that two of four HBeAg-positive chimps exhibited signs of immune reactivation, "which is believed to be a necessary step toward achieving a functional cure of HBV."
November 13, 2015
09:27 EDTMMMOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Blue Buffalo (BUFF), up 8.2%... Applied Materials (AMAT), up 3.8%... Planet Fitness (PLNT), up 9.8%... Lipocine (LPCN), up 16.2% after reporting quarterly results and that the FDA has assigned a Prescription Drug User Fee Act goal date of June 28, 2016. ALSO HIGHER: Mylan (MYL), up 10.9% after Perrgo (PRGO) shareholders did not tender enough shares for the hostile takeover bid to succeed... Plug Power (PLUG), up 7.3% after entering into a strategic supply agreement with 3M (MMM)... Yum! Brands (YUM), up after reporting that October China Same-Store Sales are up 5%. DOWN AFTER EARNINGS: Fossil (FOSL), down 24.5%... Fossil (JWN), down 20.6%... El Pollo LoCo (LOCO), down 15.1%... Cisco (CSCO), down 4.1%.... Tyco (TYC), down 4.1%... J.C. Penney (JCP), down 6.8%. ALSO LOWER: Fitbit (FIT), down 8.4% after 17M share Secondary priced at $29.00... GameStop (GME), down 8% after being downgraded to Sector Weight from Overweight at Pacific Crest... Lions Gate (LGF), down 2.6% after 3.4M share Spot Secondary priced at $39.43... Perrigo is down 10.5% after shareholders did not tender enough shares for the hostile takeover bid to succeed.
08:28 EDTARWRAmerican Association for Study of Liver Diseases to hold annual meeting
The Liver Meeting 2015 is being held in San Francisco on November 13-17.
07:05 EDTMMM3M, Plug Power announce strategic supply agreement
Plug Power (PLUG) and 3M (MMM) announce a supply agreement for membrane electrode assemblies, or MEAs, to be used in Plug Power designed proton exchange membrane, or PEM, fuel cell stacks. Through this strategic supply agreement, robust fuel cell stacks will be manufactured in Plug Power's Latham, NY and Spokane, WA facilities to support the $20B material handling market. Additionally, this new fuel cell stack technology will be utilized to expand Plug Power's presence into hydrogen enabled electric vehicle applications outside of the material handling market. Fuel cell systems using the 3M MEA's and Plug Power stack design will begin shipments in Q4.

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