Seeking Alpha
  • Friday, December 26, 2014

  • 12:48 PM
    • UnitedHealth Group (UNH -0.1%) reports Q4 and full-year results on January 21 before the open. The conference call will begin at 8:45 am.
    • Consensus revenue views for Q4 and 2014 are $33.1B and $130B, respectively.
    | Comment!
  • 12:05 PM
    • Spectrum Pharmaceuticals (SPPI +0.9%) submits a New Drug Application (NDA) to the FDA seeking approval for Orphan Drug-designated Captisol-Enabled Melphalan (CE-Melphalan) for injection (propylene glycol-free) for the use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma.
    • CE-Melphalan was developed by Ligand Pharmaceuticals (LGND +2.7%) and licensed to Spectrum in March 2013.
    • Among the benefits of Orphan Drug status is a seven-year period of market exclusivity if approved.
    | Comment!
  • 11:54 AM
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  • 11:37 AM
    • Thinly-traded nano cap Atossa Genetics (ATOS +30.8%) jumps on massive turnover of 4.9M. Shares are up 77% since Tuesday's close of $1.06. On December 19, the company announced that its subsidiary in Seattle, WA had begun pharmacogenetics testing as a service to physicians to assist them in prescribing drugs.
    • The company faces liquidity issues. In its latest 10-Q, it states that it has sufficient resources to fund operations potentially only through Q1.
    • On a dubious note, the firm has apparently hired BDO USA as its accountant. BDO covered Robert Allen Stanford's $7B Ponzi scheme.
    | 1 Comment
  • 10:50 AM
    • The judge presiding over Dr. Harry Fisch's patent suit against Repros (NASDAQ:RPRX) has granted a summary judgment in Repros' favor, thereby ending the dispute.
    • Fisch, an NYC urologist, had accused Repros CEO Joe Podolski of stealing the idea behind its Androxal testosterone drug during a face-to-face meeting.
    | 1 Comment
  • 8:25 AM
    • Citing the drug giant's strong balance sheet and healthy cash flow profile, RBC argues Gilead could launch a $10B+ accelerated buyback program.
    • For reference, Gilead has a $138B market cap, and spent $1.7B on buybacks in Q3. It ended the quarter with $7.7B in cash/investments, and $9.4B in debt. Should Gilead wish to tap debt markets, interest rates for investment-grade offerings remain low.
    • When asked about Gilead's capital return plans on the Q3 CC (transcript), CFO Robin Washington declared Gilead still thinks buybacks are "a more optimal way for us to return value to shareholders" than dividends.
    • GILD +0.7% premarket.
  • Thursday, December 25, 2014

  • 12:41 PM
    • Endo International plc (NASDAQ:ENDP) subsidiary Endo Pharmaceuticals and BioDelivery Sciences (NASDAQ:BDSI) submit a New Drug Application (NDA) to the FDA for Buprenorphine HCl Buccal Film for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
    • The product uses BioDelivery's BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine across the buccal mucosa (inside lining of the cheek) via a thin film that adheres to the cheek lining in less than five seconds and then completely dissolves.
    • Buprenorphine is a partial mu-opioid receptor agonist and a kappa antagonist which is different than full mu-opioid agonists like morphine. It is a Schedule III controlled substance which has a lower abuse potential than Schedule II drugs.
    | Comment!
  • 12:18 PM
    • John Ellis "Jeb" Bush notifies the Board of Directors of Tenet Healthcare (NYSE:THC) that he is resigning from the Board effective December 31. His departure is not due to any disagreement with Tenet.
  • Wednesday, December 24, 2014

  • 1:19 PM
    • Osiris Therapeutics (NASDAQ:OSIR) establishes a partnership with Stryker (NYSE:SYK) to develop and commercialize Osiris' BIO4 bone matrix tissue form. Under the terms of the collaboration agreement, Stryker has an exclusive worldwide license to BIO4 and is responsible for all commercialization activities. Osiris is responsible for the manufacturing and continued research and product improvement efforts. Both firms will collaborate on the design and conduct of future clinical trials.
    • BIO4 is a bone allograft that contains both viable cells and growth factors.
    • Specific financial terms of the partnership are undisclosed.
    | Comment!
  • 12:13 PM
    • United Therapeutics (UTHR +2.4%) submits a Pre-Market Approval (PMA) application to the FDA for the use of Medtronic's (MDT +0.7%) SynchroMed II implantable drug infusion system with Remodulin (treprostinil) to deliver the drug intravenously to patients with pulmonary arterial hypertension.
    • The company plans to submit a supplemental New Drug Application (sNDA) in January to amend Remodulin's label to include the use of the drug with the device.
    | Comment!
  • 9:01 AM
    • Achillion Pharmaceuticals (NASDAQ:ACHN) is up 6% premarket on high volume in response to the prevailing opinion that yesterday's 24% plunge on 4x normal volume was overdone. The AbbVie/Express Scripts deal stoked the biotech/pharma sell-off.
    • Previously: Money flowing out of biotech today (Dec. 23)
  • 8:52 AM
    • The FDA approves the New Drug Application (NDA) for Namzaric, a fixed dose combination of memantine HCl extended release and donepezil hydrochloride, for the treatment of moderate-to-severe dementia of the Alzheimer's type.
    • Memantine is an NMDA receptor agonist which blocks the activity of the neurotransmitter glutamate. At normal levels, glutamate aids memory and learning but it the levels are excessive, it overstimulates and eventually kills nerve cells via excitotoxicity.
    • Donepezil is a reversible acetylcholinesterase inhibitor. It inhibits the hydrolysis of acetylcholine which is a process associated with cognitive impairment.
    • Namzaric was co-developed by Adamas Pharmaceutics (NASDAQ:ADMS) and Forest Laboratories (NYSE:ACT) under the terms of an agreement signed in November 2012.
    • Adamas is due a $30M milestone payment from Forest for the approval.
    • ADMS is up 19% premarket on moderate volume.
    | Comment!
  • 7:11 AM
    • The FDA grants Orphan Drug status to BioCryst Pharmaceuticals' (NASDAQ:BCRX) BCX4161 for the prevention of acute attacks of angioedema in patients with hereditary angioedema (HAE).
    • BCX4161 is a novel selective inhibitor of plasma kallikrein which, in turn, suppresses bradykinin production. Bradykinin is the mediator of acute swelling attacks in patients with HAE.
    • Among the benefits of the Orphan Drug designation is a seven-year period of market exclusivity if approved.
    | 1 Comment
  • Tuesday, December 23, 2014

  • 4:41 PM
    • The FDA grants Orphan Drug status to Amarantus BioScience Holdings' (OTCQB:AMBS) investigational drug MANF (mesencephalic-astrocyte-derived neurotrophic factor) for the treatment of retinitis pigmentosa (RP).
    • MANF is a naturally-occurring protein that reduces and prevents apoptosis (cell death) in response to injury or disease. It was discovered with the company's proprietary PhenoGuard Protein Discovery Engine.
    • RP is an inherited degenerative eye disease that causes severe vision impairment and sometimes blindness.
    • Among the benefits of Orphan Drug status is a seven-year period of market exclusivity if approved.
    | Comment!
  • 4:29 PM
    • BioLineRx (NASDAQ:BLRX) grants an exclusive license to Omega Pharma for BL-5010 for the non-surgical removal of benign skin lesions, for over-the-counter (OTC) indications, in the territory of Europe, Australia and selected other countries. BioLineRx will retain the rights in the U.S. and rest of the world.
    • Under the terms of the agreement, Omega will be responsible for all development activities required to obtain regulatory approval in the licensed territory for at least two OTC indications. It will also be responsible for manufacturing and commercialization.
    • The specific financial terms of the contract are undisclosed.
    | Comment!
  • 4:21 PM
    • Biogen Idec (NASDAQ:BIIB) will report Q4 and full-year results on January 28 before the open. The conference call will begin at 8:30 am ET.
    • Consensus views for Q4 and 2014 are EPS of $3.78 and $13.53 on revenues of $2.6B and $9.7B, respectively.
    | Comment!
  • 4:05 PM
    • The FDA approves Novo Nordisk's (NYSE:NVO) Saxenda (liraglutide [rDNA origin] injection) for the treatment of chronic weight management in addition to a reduced-calorie diet and physical activity in adults with a body mass index (BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related co-morbidity such as hypertension, type 2 diabetes or high cholesterol.
    • Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist in the same class as the company's glucose management medicine Victoza.
    • Weight management drug-related tickers: (NASDAQ:OREX) (NASDAQ:VVUS) (NASDAQ:ARNA)
  • 2:23 PM
    • Smith & Nephew (SNN +11.2%) jumps on a 5x surge in volume in response to anonymous reports that Stryker (SYK +1.7%) is preparing a bid. Sources close to the matter say Stryker is willing to pay as much as a 30% premium to SNN's current price.
    | 1 Comment
  • 10:49 AM
  • 10:40 AM
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