Seeking Alpha
  • Today - Friday, March 6, 2015

  • 4:27 PM
    • Reuters reports GlaxoSmithKline (NYSE:GSK) is firing 110 Chinese employees following a probe launched in response to its local bribery scandal. GSK was fined RMB3B ($479M) by a Chinese court last year for bribing doctors to use its drugs, and five execs were given suspended prison sentences.
    • The drug giant insists all of the misconduct uncovered by its probe happened before mid-2013 - the point where Chinese authorities first levied bribery accusations against GSK. The company adds it has "increased our monitoring of expense claims and increased our compliance efforts" in response to the events.
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  • 2:46 PM
    • The FDA approves Astellas Pharma's (OTCPK:ALPMF) (OTCPK:ALPMY) QIDP-designated Cresemba (isavuconazonium sulfate) for the treatment of adult patients with invasive aspergillosis and invasive mucormycosis.
    • Aspergillus is a fungus whose spores are present in the air we breathe. It's normally harmless but can cause disease in people with weakened immune systems, damaged lungs or allergies. The variety of these disease is called aspergillosis.
    • Mucormycosis is caused by fungi in the order Mucorales. It can affect multiple parts of the body and is characterized by a variety of symptoms such as headache, facial pain, fever and nasal congestion that progresses to black discharge.
    • Both conditions are rare, but serious.
    • The agency designated Cresemba a Qualified Infectious Disease Product for the treatment of invasive aspergillosis in 2013. In addition to reaping the benefits of Fast Track review, it will have an additional five-year period of market exclusivity.
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  • 1:10 PM
    • Melbourne, Australia-based Genetic Technologies (GENE -20.8%) raises AUD$18.6M (US$14.3M) from U.S.-based investors via its offer of 3,333,333 American Depositary Shares (ADSs) representing 499,999,950 ordinary shares. Each ADS represents 150 ordinary shares.
    • Net proceeds will fund the commercialization of BREVAGenplus, the company's refocus on the U.S. molecular diagnostics market and working capital.
  • 11:55 AM
    • Beijing-based iKang Healthcare Group (KANG +0.7%) will report fiscal Q3 results on Monday, March 9, after the close. The conference call will begin the next day, March 10, at 8:00 am ET.
    • Consensus view is EPS of $0.26 on revenues of $108.5M.
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  • 10:34 AM
    • Thinly-traded small cap Retrophin (RTRX +12.5%) clears resistance at $15 although the breakout is on a rather anemic 20% surge in volume. After the close yesterday, the company reported Q4 revenue of $14.1M versus no revenue a year earlier. Revenue for the year was $28.2M also up from $0 the previous year.
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  • 10:17 AM
    • WuXi Pharmatech (WX -9.8%) drops on double normal volume after it announced guidance that was below consensus views. Its outlook for adjusted earnings per ADS for Q1 is $0.30 - 0.32 versus the consensus of $0.47. For the year, it expects earnings of $1.73 - 1.78 compared to consensus of $2.10.
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  • 9:53 AM
    • The USDA's Center for Veterinary Biologicals clears Abaxis' (ABAX -0.2%) VetScan Anaplasma Rapid Test Kit for the detection of Anaplasma phagocytophelium and A. platys in canine whole blood, serum or plasma samples. Both are Gram-negative bacteria that cause anaplasmosis, a disease in dogs characterized by bruising on the gums and belly and spontaneous nosebleeds. The bacteria are transmitted by ticks.
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  • 9:28 AM
    • Isis Pharmaceuticals (NASDAQ:ISIS) earns a $9M milestone payment from Biogen Idec (NASDAQ:BIIB) for advancing the ongoing Phase 3 trial evaluating ISIS-SMNrx for the treatment of infants with spinal muscular atrophy (SMA).
    • The study is a randomized, double-blind, sham-procedure-controlled 13-month trial in ~110 infants diagnosed with SMA.  The primary endpoint is survival or time to permanent ventilation.
  • 9:21 AM
    • Jerusalem, Israel-based BioLineRx (NASDAQ:BLRX) prices its public offering of 12.5M American Depositary Shares (ADSs) at $2 per ADS. Each ADS represents 10 ordinary shares. Underwriters over-allotment is an additional 1.875M ADSs. Closing date is March 11.
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  • 9:12 AM
    • The FDA approves Sandoz's (NYSE:NVS) Zarxio, a biosimilar to Amgen's (NASDAQ:AMGN) Neupogen (filgrastim), for the same indications as Neupogen.
    • Zarxio is approved for the treatment of patients with cancer receiving myelosuppressive chemotherapy, patients with acute myeloid leukemia receiving induction or consolidation chemotherapy, patients with cancer undergoing bone marrow transplantation, patients undergoing autologous peripheral blood progenitor cell collection and therapy and patients with severe chronic neutropenia.
    • The placeholder nonproprietary name for Zarxio is "filgrastim-sndz."
    • Previously: FDA Ad Comm gives thumbs up to Sandoz biosimilar filgrastim (Jan. 7)
    | 1 Comment
  • 9:00 AM
    • The German Court of Appeal rules that Eli Lilly's (NYSE:LLY) vitamin regimen patent for its cancer drug Alimta (pemetrexed disodium) would not be infringed by a generic competitor that intends to market a dipotassium salt form of pemetrexed in Germany once the compound patent expires in December. The decision vacated the prior decision of the Regional Court of Dusseldorf in April of last year.
    • Lilly SVP and General Counsel Michael J. Harrington says, "We strongly disagree with the ruling by the German Court of Appeal regarding Alimta's vitamin regimen patent. Although, Alimta's compound patent remains in force and is expected to provide exclusivity in Germany through December 2015, we continue to believe that Alimta's vitamin regimen patent would be infringed by the entry of generic pemetrexed products, including alternative salt forms, in Europe prior to June 2021. We will seek permission to appeal this ruling to the German Supreme Court."
    • In April 2014, the English High Court made a similar ruling pertaining to alternative salt forms of pemetrexed in the U.K., Italy, France and Spain. The appeal of the decision in pending and is scheduled for hearing starting March 9.
    • Lilly's vitamin regimen patent was upheld in a prior ruling by the Opposition Division of the European Patent Office. An appeal is pending before the Technical Board of Appeal of the European Patent Office.
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  • 8:25 AM
    • Thinly-traded micro cap Calithera Biosciences (NASDAQ:CALA) is up 37% premarket on modest volume in response to its deal with High Point Pharmaceuticals and TransTech Pharma to develop and commercialize High Point's hexokinase 2 inhibitors for the treatment of cancer.
    • Previously: Calithera Bio inks development deal for cancer drug candidates (March 5)
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  • 8:11 AM
    • MusclePharm (OTCQB:MSLP) promotes EVP of Finance John Price to Chief Financial Officer. He replaces Donald Prosser will depart when his employment terminates on April 15.
  • 8:04 AM
    • In a trial over injuries blamed on the TVT Abbrevo transvaginal mesh, a California jury ordered Johnson & Johnson's (NYSE:JNJ) Ethicon unit to pay $5.7M to plaintiff Coleen Perry. After more than three days of deliberation in Kern County, jurors found Ethicon liable for problems with the design of TVT Abbrevo and failing to warn patients about its risks. Ms. Perry was awarded $700K in compensatory damages and $5M in punitive damages.
    • The verdict is the fourth win for plaintiffs suing the company over the product. More than 36,000 lawsuits have been filed in state and federal courts over the devices, which are used to treat stress urinary incontinence and pelvic organ prolapse. The FDA cleared it for sale in 2010.
    • Ethicon won one trial in federal court in West Virginia, where another one started on Monday. Ethicon spokesman Matthew Johnson says the company believes it has strong grounds for an appeal of the California verdict. He says Ethicon stands behind the safety and effectiveness of Abbrevo, as well as its development and marketing.
    • Ethicon, Boston Scientific (NYSE:BSX) and C.R. Bard (NYSE:BCR) face more than 70,000 mesh injury lawsuits in federal court and thousands more in state courts. In December, a federal judge advised Bard to settle more than 12,000 lawsuits in light of the large verdicts awarded to date.
    • Previously: Judge advises Bard to settle mesh lawsuits (Dec. 12, 2014)
    • Previously: Boston Sci loses first federal case over vaginal mesh product (Nov. 14, 2014)
  • 7:38 AM
    • Sunshine Heart (NASDAQ:SSH) suspends patient enrollment in the Phase 3 clinical trial evaluating its C-Pulse Heart Assist System in patients with NYHA Class III and ambulatory Class IV heart failure after four of the first twenty patients died. Two have been adjudicated by an independent Clinical Events Committee as being non-device related. The company has received documentation from the sites that reported the most recent two deaths that these were also non-device related. Currently enrolled patients will continue follow-up according to the study protocol.
    • The FDA has advised Sunshine to file an IDE supplement that addresses the reasons for the temporary suspension of the trial and a plan for its resumption. The company intends to submit the document by March 16.
    • CEO Dave Rosa says, "We are confident this matter will be resolved in a very short time frame. While the current data suggest these incidents are non-device related, we have decided that in the absolute interest of patient safety, having a temporary pause in enrollment is the right course of action while we work with the FDA to discuss the findings."
    • One of the study's principal investigators, Dr. Bill Abraham, will be available during the company's March 17 earnings call to answer questions.
    • SSH is down 30% premarket on robust volume.
  • 7:16 AM
    • Amarin (NASDAQ:AMRN) enters into a definitive securities subscription agreement with institutional investors, both existing and new, for the private placement of up to a maximum of $52.8M of restricted American Depositary Shares at $0.15, each representing one share of the company's non-voting Series A Convertible Preference Shares.
    • Each ten Series A Convertible Preference Shares may be consolidated and redesignated as one ordinary share up to a maximum aggregate of 35,215,079 ordinary shares.
    • Net proceeds of ~$52.2M will fund the commercialization of Vascepa, advance the REDUCE-IT cardiovascular outcomes trial and general corporate purposes.
  • 7:01 AM
    • Chimerix (NASDAQ:CMRX): Q4 EPS of -$0.52 misses by $0.04.
    • Revenue of $1.16M (+31.8% Y/Y) beats by $0.19M.
    • Press Release
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  • 6:15 AM
    • AVEO Pharmaceuticals (NASDAQ:AVEO): Q4 EPS of -$0.27 misses by $0.06.
    • Revenue of $0.12M (-62.5% Y/Y)
  • 6:03 AM
    • Digirad (NASDAQ:DRAD): Q4 EPS of $0.05 beats by $0.03.
    • Revenue of $14.1M (+12.6% Y/Y)
    • Press Release
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  • Thursday, March 5, 2015

  • 10:36 PM
    • Thinly-traded nano cap Targacept (NASDAQ:TRGT) and privately-held South San Francisco-based Catalyst Biosciences agree to merge. The new entity will be named Catalyst Biosciences and will have the anticipated stock symbol "CBIO." Catalyst CEO Nassim Usman, Ph.D., will be President and CEO of the combined firm.
    • Catalyst shareholders will initially own ~65% of the combined company. Targacept shareholders will own ~35% and will receive a dividend of an aggregate of $37M in non-interest bearing redeemable convertible notes and ~$20M in cash. The notes will be convertible into the new entity's common stock at any time within two years after the deal closes, at the noteholders' discretion, for $1.31 per share which is 130% of the negotiated per-share value of Targacept's assets after the distribution of the dividend.
    • Catalyst's product development activities focus on hemostasis and complement regulation. Its lead product is CB 813d for hemophilia. Targacept focuses on a class of products called neuronal nicotinic receptors. Its lead product is TC499 for the treatment of diabetic gastroparesis. Both are in Phase 1 development.
    • TRGT is down 3% after hours on high volume.
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