Seeking Alpha
  • Today - Tuesday, April 28, 2015

  • 6:06 AM
    • Icon (NASDAQ:ICLR): Q1 EPS of $0.86 beats by $0.04.
    • Revenue of $388.23M (+11.0% Y/Y) misses by $2.88M.
    • Press Release
    | Comment!
  • 6:04 AM
    • Centene (NYSE:CNC): Q1 EPS of $0.52 beats by $0.04.
    • Revenue of $5.13B (+48.3% Y/Y) beats by $10M.
    • Press Release
    | Comment!
  • 6:03 AM
    • United Therapeutics (NASDAQ:UTHR): Q1 EPS of $2.55 beats by $0.41.
    • Revenue of $327.5M (+13.2% Y/Y) misses by $26M.
    • Press Release
    | Comment!
  • 6:02 AM
    • Aetna (NYSE:AET): Q1 EPS of $2.39 beats by $0.44.
    • Revenue of $15.09B (+8.0% Y/Y) misses by $370M.
    • Press Release
    | 1 Comment
  • Monday, April 27, 2015

  • 11:57 PM
    • MSA Safety (NYSE:MSA): Q1 EPS of $0.42 misses by $0.10.
    • Revenue of $257M (-3.0% Y/Y) misses by $21.55M.
    • Press Release
    | Comment!
  • 11:40 PM
    • MiMedx Group (NASDAQ:MDXG): Q1 EPS of $0.04 beats by $0.01.
    • Revenue of $40.77M (+108.4% Y/Y) misses by $0.07M.
    • Press Release
    | 1 Comment
  • 7:35 PM
    • Results from a 14,724-patient CV risk study, TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin), showed Merck's (NYSE:MRK) Januvia (sitagliptin) was no worse than (non-inferior) placebo in cardiovascular (CV) risk as measured by the composite CV endpoint. The composite CV endpoint was defined as the composite of time to the first of any of the following confirmed events: CV-related death, nonfatal myocardial infarction, nonfatal stroke or unstable angina requiring hospitalization. The mean followup period was ~three years.
    • Also, there was no increase in hospitalization for heart failure in the sitagliptin cohort versus placebo.
    • The complete results will be presented on June 8 at the 75th Scientific Sessions of the American Diabetes Association.
    • Januvia is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
    | 1 Comment
  • 5:42 PM
    • Owens & Minor (NYSE:OMI) Q1 results ($M): Net Revenues: 2,391.2 (+6.0%); SG&A: 233.8 (+3.6%); Operating Income: 41.0 (-11.4%); Net Income: 18.9 (-25.9%); EPS: 0.30 (-26.8%); Quick Assets: 159.1 (+180.1%); CF Ops: 168.7 (+81.0%).
    • 2015 Guidance: Non-GAAP EPS: $1.90 - 1.95 (unch).
    | Comment!
  • 5:04 PM
    • Universal Health Services (NYSE:UHS): Q1 EPS of $1.78 beats by $0.22.
    • Revenue of $2.23B (+14.9% Y/Y) beats by $100M.
    • Shares +2.3% AH.
    • Press Release
    | Comment!
  • 4:53 PM
    • A joint meeting of the FDA's Cellular, Tissue and Gene Therapies Advisory Committee and the Oncologic Drugs Advisory Committee is on tap for this Wednesday. The two groups will discuss and make recommendations regarding regulatory approval of Amgen's (NASDAQ:AMGN) Biologic License Application (BLA) for talimogene laherparepvec for the treatment of patients with injectable regionally or distantly metastatic melanoma.
    • Briefing doc
    • Amgen's briefing doc
    | Comment!
  • 4:38 PM
    • United Therapeutics (NASDAQ:UTHR) will report Q1 results tomorrow before the open. Consensus view is EPS of $2.14 on revenues of $353.5M.
    | Comment!
  • 4:36 PM
    • Pfizer (NYSE:PFE) will report Q1 results tomorrow before the open. Consensus view is EPS of $0.49 on revenues of $10.7B.
    | Comment!
  • 4:34 PM
    • Merck (NYSE:MRK) will report Q1 results tomorrow before the open. Consensus view is EPS of $0.74 on revenues of $9B.
    | Comment!
  • 4:31 PM
    • Bristol-Myers Squibb (NYSE:BMY) will report Q1 results tomorrow before the open. Consensus view is EPS of $0.51 on revenues of $3.8B.
    | Comment!
  • 4:29 PM
    • Boston Scientific (NYSE:BSX) will report Q1 results tomorrow before the open. Consensus view is EPS of $0.21 on revenues of $1.8B.
    | Comment!
  • 4:16 PM
    • Zogenix (NASDAQ:ZGNX) promotes President Stephen Farr, Ph.D, to CEO effective immediately. He succeeds Roger Hawley who will continue to serve on the Board.
    | 1 Comment
  • 4:12 PM
    • GW Pharmaceuticals (NASDAQ:GWPH) commences a public offering of 1.25M American Depositary Shares (ADSs). Underwriters over-allotment is an additional 187.5K shares. Price and terms have yet to be announced.
    | 4 Comments
  • 4:10 PM
    • Paratek Pharmaceuticals (NASDAQ:PRTK) commences a $60M public offering of common stock. Underwriters over-allotment will be an additional 15% of the number of shares offered. Price and terms have yet to be announced.
    | Comment!
  • 3:42 PM
    • Teva Pharmaceutical Industries (TEVA -4.3%) is allegedly scheduled to meet with institutional holders of Mylan (MYL -5.5%) this week in an effort to clarify the valuation necessary to close the deal. Some observers think a revised bid will be in the $85 - 95 range. Teva's first offer, which Mylan rejected, was $82.
    | 2 Comments
  • 3:30 PM
    • Two Phase 3 clinical trials evaluating Tetraphase Pharmaceuticals' (TTPH -5.1%) lead product candidate, eravacycline, show positive results for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
    • The first study, IGNITE-1, compared eravacycline to Merck's (MRK -1.1%) Invanz (ertapenem) for the treatment of cIAI. It achieved the primary endpoint of statistical non-inferiority (no worse than) of clinical response at the test-of-cure (TOC) visit. In the microbiological intent-to-treat (micro-ITT) population (n=446) 86.8% of patients receiving eravacycline achieved a clinical cure compared to 87.6% of patients receiving ertapenem (FDA criteria). In the clinically evaluable population (n=477) 92.9% of patients receiving eravacycline achieved a clinical cure versus 94.5% of patients receiving ertapenem (EMA criteria). These results were first reported in December.
    • In the lead-in portion of the second study, IGNITE-2, both IV-to-oral dosing regimens of eravacycline (1.5 mg/kg followed by 200 mg or 250 mg) compared favorably with levofloxacin, a broad spectrum antibiotic, for the treatment of cUTI. The primary endpoint, per the FDA's criteria, was the responder rate (defined as both clinical cure and successful microbiological outcome) in the micro-ITT population. The responder rates for 200 mg (n=24), 250 mg (n=28) and levofloxacin (n=23) were 75.0%, 64.3% and 56.4%, respectively. In the microbiologically evaluable population, the primary endpoint was the microbiological response per the EMA's criteria. The respective responses for levofloxacin isolates (n=24) were: 83.3%, 72.7% and 42.9%. Based on these data, the 200 mg dose will be used for the pivotal portion of the Phase 3 that is currently underway.
    • The company expects to submit its regulatory applications by the end of the year.
    • The data were presented at this week's 25th European Congress of Clinical Microbiology and Infectious Diseases in Copenhagen, Denmark.
    • Previously: Tetraphase antibiotic non-inferior to ertapenem in Phase 3 study (Dec. 17, 2014)
    | Comment!
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