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Stock Market & Financial Investment News

News For NVO;VPHM;INFI;MRK;AGN;SHPG;SGEN;OREX;AMGN;SNY;JNJ;PFE From The Last 14 Days
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April 21, 2015
16:04 EDTAMGNAmgen raises FY15 EPS view to $9.35-$9.65 from $9.05-$9.40, consensus $9.32
Narrows FY15 revenue view to $20.9B-$21.3B from $20.8B-$21.3B, consensus $20.98B.
16:02 EDTAMGNAmgen reports Q1 EPS $2.48, consensus $2.10
Reports Q1 revenue $5.03B, consensus $4.91B.
15:28 EDTAMGNNotable companies reporting after market close
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14:02 EDTOREXParagraph IV patent challenges submitted to FDA for Orexigen's Contrave
An Abbreviated New Drug Application, or ANDA, has been received by the Office of Generic Drugs containing a "Paragraph IV" patent certification for Contrave, the weight loss drug whose patent is owned by Orexigen Therapeutics, according to an FDA notice. The date on which the first substantially complete generic drug application was submitted to the Agency for Contrave was March 12, according to the posting. Reference Link
13:51 EDTAMGNEarnings Watch: Amgen's Enbrel, Neulasta sales key for Q1 results
Amgen (AMGN) is scheduled to report first quarter earnings after the market close on Tuesday, April 21 with a conference call scheduled for 5:00 pm ET. Amgen, a biotechnology medicines company, engages in the discovery, development, manufacture, and marketing of human therapeutic products in the areas of supportive cancer care, inflammation, nephrology, and bone diseases. EXPECTATIONS: Analysts are looking for earnings per share of $2.10 on revenue of $4.91B, according to First Call. The consensus range for EPS is $1.91-$2.25 on revenue of $4.62B-$5.13B. LAST QUARTER: Amgen reported fourth quarter EPS of $2.16 against estimates of $2.05 on revenue of $5.33B against estimates of $5.2B. With its Q4 report, Amgen also reiterated its fiscal year EPS view of 9.05-$9.40, on revenue of of $20.8B-$21.3B. Total product sales increased 8% for Q4 versus Q4 of 2013. The increase was driven primarily by Enbrel, Neulasta, Prolia, XGEVA and Vectibix .Growth for the quarter was due primarily to higher unit demand, and to a lesser extent, price. Product sales increased 6% for the full year driven by strong performance across the portfolio. STREET RESEARCH: On March 23, Piper Jaffray said the "positive" trial data Teva (TEVA) reported for its anti-CGRP antibody in migraines is another important validation for the class of drugs that is also being worked on by Amgen, Eli Lilly (LLY), and Alder Biopharmaceuticals (ALDR). The firm said it thinks Amgen is one of the leaders in CGRP antibody space and reiterated its Overweight rating and $187 price target on Amgen shares. On March 16, RBC Capital said it believes that data presented by Amgen on its evolocumab drug for hyperlipidemia.was "very positive." The firm expects the drug to be approved in late summer. It predicts that revenue from the drug will ramp modestly and steadily, and then accelerate after positive studies of the drug's effects are released in 2017. RBC Capital estimates that worldwide revenue from the drug will peak at $2.5B+. It keeps an Outperform rating on Amgen. PRICE ACTION: Amgen shares are higher by around 6% since its last earnings report on January 27, and are up 1.25% to to $168.06 in afternoon trading ahead of Tuesday's earnings report.
10:01 EDTPFEPfizer receives FDA breakthrough therapy designation for Xalkori
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09:01 EDTSNYGenzyme initiates Phase 2a trial to evaluate pharmocodynamics of GZ/SAR402671
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08:30 EDTMRKMerck reaffirms commitment to developing medicines for infectious diseases
Merck reaffirmed its longstanding commitment to discovering and developing novel medicines in the global fight against infectious diseases, including infections caused by resistant bacteria and other pathogens. At this year’s 25th European Congress of Clinical Microbiology and Infectious Diseases, April 25-28 in Copenhagen, Denmark, researchers are scheduled to present more than 30 scientific data presentations on the company’s broad portfolio of marketed and investigational anti-infective medicines. Merck completed its acquisition of Cubist Pharmaceuticals, Inc. on Jan. 21, 2015, and continues to build on both companies’ work in infectious disease. Antimicrobial research remains an important area of focus. In addition to a combined portfolio of antibiotic and antifungal medicines, vaccines, and medicines for HIV and HCV, Merck has multiple programs that span discovery through late-stage development. In total, Merck currently has more than 15 ongoing clinical trials evaluating antibiotic, antifungal and antiviral agents for the prevention and treatment of infectious disease. These trials are projected to enroll approximately 8,000 patients.
08:18 EDTPFEPain Therapeutics resumes responsibility for Remoxy
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08:06 EDTPFEPfizer says Phase 3 inotuzumab ozogamicin study met first primary endpoint
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April 20, 2015
14:32 EDTJNJ, SHPGPharmacyclics patent for Imbruvica challenged by Hayman Capital's Bass
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13:01 EDTINFIInfinity Pharmaceuticals reports preclinical data for duvelisib with venetoclax
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11:20 EDTSGENSeattle Genetics likely to gain approval in post-transplant HL, says Piper
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09:20 EDTSNYLeerink biotech analyst holds an analyst/industry conference call
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09:01 EDTSGENSeattle Genetics says FDA accepts sBLA for Adcetris
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08:05 EDTMRKTetraLogic, Merck enter into oncology clinical study collaboration
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08:02 EDTPFEMerck KGaA, Pfizer initiate Phase III study with Avelumab
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07:20 EDTMRKAmerican Association for Cancer Research to hold annual meeting
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06:59 EDTJNJJohnson & Johnson added to short-term buy list at Deutsche Bank
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06:05 EDTPFEProvectus receives notice of allowance for PV-10 combined with other drugs
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