LATEST
  • Tuesday, May 31, 2016

  • 9:57 PM
    • Pfizer (NYSE:PFE) prices its $5B aggregate principal value of notes. The offering consists of five tranches: $1.125B of 1.200% notes due 2018; $850M of 1.450% notes due 2019; $1.15B of 1.950% notes due 2021; $1.25B of 2.750% notes due 2026 and $500M of 4.400% notes due 2044.
    • Net proceeds will be used for general corporate purposes, including the repayment of a portion of outstanding commercial paper.
    • Closing date is June 3.
    | 9:57 PM | 2 Comments
  • 6:29 PM
    • Mylan N.V. (NASDAQ:MYL) prices its private placement of $6.5B aggregate principal amount of senior notes as follows: $1.0B of 2.50% senior notes due 2019 at 99.888%; $2.25B of 3.15% senior notes due 2021 at 99.884%; $2.25B of 3.95% due 2026 at 99.231% and $1.0B of 5.25% senior notes due 2046 at 99.984%.
    • Net proceeds will fund the Meda AB acquisition. Closing date is June 9.
    | 6:29 PM
  • 6:22 PM
    • Valeant Pharmaceuticals (NYSE:VRX) sets June 7 at 8:00 am ET for its conference call to discuss Q1 results. Consensus view is EPS of $1.38 on revenues of $2.39B.
    | 6:22 PM | 38 Comments
  • 6:06 PM
    • Gary Lauer is "transitioning out" as eHealth's (NASDAQ:EHTH) chairman and CEO. He'll remain with the company in an advisory role until year's end.
    • Scott Flanders, a director since 2008 and previously the CEO of Playboy Enterprises, Freedom Communications, and Columbia House, is eHealth's new CEO. Ellen Tauscher, a director since 2012 and a former 7-term member of Congress, has been named non-executive chairman.
    • Tauscher: "We believe that Scott's decades of executive leadership experience, in addition to his expertise in direct-to-consumer markets and track record of overseeing significant growth, will allow him to seamlessly transition into the role of eHealth's CEO. Scott is the right leader to guide eHealth as we build on our positive momentum and strengthen our position as the leader in online health insurance."
    | 6:06 PM
  • 5:09 PM
    • Adeptus Health (NYSE:ADPT) initiates a public offering of 2.75M Class A common shares, consisting of 1,843,162 to be sold by the company and 906,838 by an affiliate of institutional stockholder Sterling Partners. Net proceeds will fund the purchase of 1,843,162 limited liability units of direct subsidiary Adeptus Health LLC held by some investors, including certain directors and executives. The company will receive no proceeds from the offering.
    • Underwriters over-allotment is an additional 412.5K Class A shares. Price and terms have yet to be announced.
    • Shares are down 7% after hours on light volume.
    | 5:09 PM
  • 4:49 PM
    • Prompted by a negative Ad Comm vote in the U.S. and a looming negative vote in Europe, BioMarin Pharmaceuticals (NASDAQ:BMRN) terminates development of Kyndrisa (drisapersen) for the treatment of Duchenne muscular dystrophy (DMD) patients amenable to skipping exon 51. The company is also terminating development of first-generation follow-on products BMN 044, BMN 045 and BMN 053, all currently in Phase 2.
    • Despite the setback, the company will continue to explore the development of next-generation oligonucleotides for the treatment of DMD.
    • BioMarin still expects to be non-GAAP break even or better in 2017.
    • Shares are down a fraction after hours on increased volume.
    | 4:49 PM
  • 4:25 PM
    • Biondvax Pharmaceuticals (NASDAQ:BVXV): Q1 EPS of -NIS 0.01
    • Cash and cash equivalents of NIS 33.88M
    • Press Release
    | 4:25 PM
  • 4:20 PM
    • Intrexon's (NYSE:XON) Oxitec announces a multi-year expansion of its program deploying "friendly" Aedes aegypti mosquitoes (OX513A) in two areas of Brazil with the aim of controlling the spread of the mosquito-borne viruses dengue, chikungunya and Zika. The current project, in the CECAP/Eldorado district of the city of Piracicaba where 5,000 people call home, will be extended for another year.
    • In addition, a new two-year project in the center of Piracicaba, home to 60,000 people, will commence. To support the larger area, Oxitec will build a new production facility in the city that will have a 60M mosquito/week capacity.
    • Brazilian authorities are encouraged by the positive results achieved in the first study. From July 2014 to July 2015, CECAP/Eldorado had 133 dengue cases, but this dropped to seven in the period July 2015 to May 20, 2016 after the OX513A efficacy trial was instituted which resulted in a 90% drop in the wild A. aegypti population.
    | 4:20 PM | 5 Comments
  • 4:06 PM
    • Innocoll (NASDAQ:INNL): Q1 EPS of -$0.90 misses by $0.16.
    • Revenue of $1.6M (+142.4% Y/Y) beats by $0.61M.
    • Press Release
    | 4:06 PM
  • 1:54 PM
    • Micro cap Amarin (AMRN +7%) is up on double normal volume in response to its announcement that the FDA has determined that Vascepa (icosapent ethyl) capsules are eligible for five-year new chemical entity (NCE) marketing exclusivity under the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act. The NCE exclusivity will be in effect from the date of FDA approval, July 26, 2012 until July 26, 2017.
    • In addition, there is a statutory 30-month stay triggered by patent litigation (the company is automatically notified when a would-be generic competitor files its Abbreviated New Drug Application with the FDA which, in turn, automatically results in patent infringement litigation which triggers the automatic 30-month stay while the patent challenge runs its course) that potentially extends Vascepa's marketing exclusivity to January 26, 2020.
    • Vascepa accounted for almost all (99%) of the company's Q1 revenue of $25.5M.
    | 1:54 PM
  • 1:36 PM
    • The FDA designates Soligenix's (OTCQB:SNGX +1.4%) investigational SGX943 (dusquetide) for Fast Track review for the treatment melioidosis, a potentially fatal infection caused by the Gram-negative bacterium Burkholderia pseudomallei, which is highly resistant to many antibiotics. It is a major public health issue in Southeast Asia and Northern Australia. The mortality rate can be as high as 40%.
    • Dusquetide is a member of a class of peptides called an innate defense regulator (IDR) which has no direct antibiotic activity but modulates host responses, increasing survival and accelerating the resolution of tissue damage following exposure to pathogens.
    • Fast Track status allows for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
    | 1:36 PM | 1 Comment
  • 1:11 PM
    • Investors appear unimpressed with thinly traded nano cap CymaBay Therapeutics's (CBAY +1.6%) announcement of an early end to its Phase 2 proof-of-concept study of MBX-8025 in primary biliary cholangitis (PBC), an autoimmune disease formerly known as primary biliary cirrhosis in which the liver's bile ducts are slowly destroyed. Shares were up over 11% in early trading but failed to hold the gain despite the positive effects on various biomarkers associated with cholestasis (reduction/stoppage of bile flow).
    • The source of the softness appears to be observed increases in enzymes called transaminases in three subjects. Elevated levels of these enzymes indicate liver stress while high elevations suggest possible liver damage. All three reversed when treatment with MBX-8025 was stopped (two instances in the 200 mg arm and one in the 50 mg arm). The unwanted side effect was not observed in earlier studies involving the same two dosage levels.
    • The company says it will need to assess a lower dose of MBX-8025 in subsequent studies which, of course, might affect efficacy.
    • MBX-8025 is an agonist of peroxisome proliferator-activated receptor delta, a nuclear receptor that regulates genes involved in lipid transport, storage and metabolism in liver and muscle.
    | 1:11 PM | 3 Comments
  • 12:19 PM
    • The FDA accepts for review Vertex Pharmaceuticals' (VRTX +2.6%) supplemental New Drug Application (sNDA) seeking approval for the use of ORKAMBI (lumacaftor/ivacaftor) in patients with cystic fibrosis (CF) ages 6-11 who have two copies of the F508del mutation. The agency's action date (PDUFA) is September 30.
    • ORKAMBI is currently approved for CF patients at least 12 years old with two copies of the F508del mutation.
    | 12:19 PM
  • 11:53 AM
    • The FDA accepts for review Lexicon Pharmaceuticals' (LXRX +3.1%) New Drug Application (NDA) seeking approval of telotristat etiprate for he treatment of carcinoid syndrome, a rare condition that affects some cancer patients with metastatic neuroendocrine tumors (mNETs) that have spread to the liver and other organs from the GI tract. It is characterized by frequent and debilitating diarrhea, facial flushing, abdominal pain, fatigue and, eventually, heart valve damage.
    • Telotristat etiprate inhibits tryptophan hydroxylase, an enzyme that triggers excess serotonin production within mNET cells that leads to carcinoid syndrome.
    • The agency's action date (PDUFA) is November 30 as allowed under Priority Review status.
    • Shares are up 3% on average volume.
    | 11:53 AM
  • 11:34 AM
    • The FDA designates Cidara Therapeutics' (CDTX +4.9%) investigational CD101 topical a Qualified Infectious Disease Product (QIDP) for Fast Track review for the treatment of vulvovaginal candidiasis (VVC) and for the prevention of recurrent VVC, a condition that affects 75% of women in their lifetime.
    • CD101 topical belongs to a class of antifungals called echinocandins, commonly referred to as the "penicillin of antifungals," that have a broad spectrum of activity against Candida, the typical cause of vaginal yeast infections. Their mechanism of action is inhibiting the synthesis of glucan in the cell wall via the inhibition of a certain enzyme. 
    • As part of the FDA's accelerated approval programs, QIDP status provides an additional five-year period of market exclusivity for the indication, if approved. Fast Track status allows for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
    | 11:34 AM
  • 11:00 AM
    | 11:00 AM | 5 Comments
  • 11:00 AM
    • Thinly traded nano cap StemCells (STEM -81.9%) craters on almost a 20x surge in volume in response to its announcement that it has terminated its Phase 2 Pathway Study, assessing its HuCNS-SC human neural stem cells in spinal cord injury, due to lack of demonstrated effect, specifically a declining trend in the magnitude of treatment effect in both strength and function at month 12. An analysis by the Data Monitoring Committee showed the study was unlikely to achieve its primary efficacy endpoint.
    • Bullish expectations stoked a brief rally several weeks ago after the company reported positive interim results from six patients.
    • Previously: Bullish investors stoke buying in StemCells ahead of Pathway study data release; shares up 22% (May 11)
    | 11:00 AM | 20 Comments
  • 10:44 AM
    • Thinly traded micro cap Osiris Therapeutics (OSIR -14.8%) is down on higher-than-normal volume in response to a regulatory filing in which the company discloses that it is the target of a criminal investigation by the U.S. Attorney's Office for the Southern District of New York concerning matters currently being investigated by the SEC.
    | 10:44 AM
  • 10:32 AM
    • The FDA approves once-daily Jentadueto XR (linagliptin and metformin hydrochloride extended-release) tablets for the treatment of adults with type 2 diabetes (T2D). It is indicated as an adjunct to diet and exercise to improve glycemic control in adult type 2 diabetics where the use of both drugs is appropriate.
    • The product is the seventh new treatment approved in the U.S. from the 2011 diabetes alliance between Eli Lilly (LLY +0.7%) and Boehringer Ingelheim.
    • The FDA approved the original formulation of Jentadueto in January 2012.
    | 10:32 AM
  • 10:12 AM
    • Although up a bit more premarket, Allergan (AGN +1.2%) is still up modestly on the news that investor Carl Icahn has acquired a large stake in the BOTOX maker.
    | 10:12 AM | 6 Comments
  • 10:05 AM
    • Interim data from four patients with Homozygous Familial Hypercholesterolemia (HoFH) treated with Regeneron Pharmaceuticals' (REGN +0.4%) evinacumab (REGN1500) experienced significant reductions in low-density lipoprotein cholesterol (LDL-C) levels. The results were presented at the 84th European Atherosclerosis Society Congress in Innsbruck, Austria.
    • The patients achieved a mean reduction of 55% of LDL-C versus baseline (range: 25 - 90%) after a single 250 mg subcutaneous injection at baseline followed by a 15mg/kg IV infusion at week 2. All patients were receiving maximum doses of statin plus ezetimibe [Merck's (MRK) Zetia]. Evinacumab was generally well-tolerated with no adverse events leading to discontinuation. The most common drug-related adverse events were injection site reactions.
    • The ongoing single-arm, open-label study will enroll up to eight HoFH patients.
    • HoFH is the most severe form of hypercholesterolemia. It's rare, affecting less than 1,000 Americans, but sufferers have levels of "bad cholesterol" up to 1,000 mg/dL, ten times the optimal amount.
    • Evinacumab, created with the company's VelocImmune technology platform, is a human monoclonal antibody that binds to a protein called angiopoietin-like 3 (ANGPTL3), a natural inhibitor of an enzyme that plays a key role in the breakdown of triglycerides and other lipids.
    | 10:05 AM | 1 Comment
  • 9:51 AM
    • Medtronic (MDT) FQ4 results: Revenues: $7,567M (+3.6%); R&D Expense: $575M (+8.9%); SG&A: $2,360M (-1.8%); Operating Income: $1,506M (+303.8%); Net Income: $1,104M; EPS: $0.78; Non-GAAP EPS: $1.27 (+9.5%).
    • FY2016 results: Revenues: $28,833M (+42.3%); R&D Expense: $2,224M (+35.6%); SG&A: $9,469M (+37.2%); Operating Income: $5,291M (+40.5%); Net Income: $3,538M (+32.3%); EPS: $2.48 (+2.9%); Non-GAAP EPS: $4.37 (+2.1%); Quick Assets: $2,876M (-40.6%); CF Ops: $5,218M (+6.4%).
    • FY2017 Guidance: Revenue growth: 5.0 - 6.0%; Non-GAAP EPS: $4.60 - 4.70 (includes negative currency impact of $0.20 - 0.25).
    | 9:51 AM
  • 9:31 AM
    • Advanced Accelerator (AAAP) Q1 results (€): Revenues: 26.9M (+29.3%); Operating Loss: (1.1M) (+31.3%); Net Loss: (3M) (+49.2%); Loss Per Share: (0.04) (+55.6%); Quick Assets: 88.4M (-25.7%); CF Ops: (2.7M) (+6.9%).
    • No guidance given.
    | 9:31 AM
  • 9:23 AM
    • In a regulatory filing, Valeant Pharmaceuticals (NYSE:VRX) discloses the details of its Separation Agreement with former chief Micheal Pearson. In exchange for a general release of claims, Mr. Pearson will receive a severance payment of $9M and the continuation of medical coverage for two years. He will also be required to hold the 1M shares of common stock he received in the settlement of his equity awards for two years.
    • Pearson will provide consulting services through December 2017 subject to one-month renewals after 2017. He will receive $83,333 per month through the end of this year and $15,000 per month thereafter. The company will provide him with office space and nonexclusive access to an administrative assistant and IT support for two years.
    | 9:23 AM | 65 Comments
  • 9:10 AM
    • uniQure (QURE) Q1 results (€): Revenues: 3.9M (+254.5%); R&D Expense: 15.1M (+49.5%); SG&A: 6.6M (+57.1%); Operating Loss: (21.6M) (-148.3%); Net Loss: (20.6M) (-63.5%); Loss Per Share: (0.83) (-20.3%); Quick Assets: 184.6M (-9.3%); CF Ops: (14.8M) (-23.3%).
    • No guidance given.
    | 9:10 AM
  • 9:05 AM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Biogen's (NASDAQ:BIIB) TYSABRI (natalizumab) for use as disease modifying therapy (DMT) for relapsing-remitting multiple sclerosis (RRMS) patients with highly active disease activity despite a full and adequate course of treatment with at least one DMT.
    • The data supporting the company's application, called a type-II variation, was generated in a 10-year prospective real-study study called TOP (TYSABRI Observational Program).
    • A final decision from the European Commission usually takes ~60 days.
    | 9:05 AM | 1 Comment
  • 8:41 AM
    • The FDA approves Allergan's (NYSE:AGN) supplemental New Drug Application (sNDA) seeking approval of TEFLARO (ceftaroline fosamil) for the treatment of pediatric patients aged two months to 18 years who have acute bacterial skin and skin structure infections (ABSSSI), including those caused by methicillin-resistant Staphylococcus aureus (MRSA), and community-acquired bacterial pneumonia (CABP).
    • According to the company, there are more than 70K hospitalizations in the U.S. each year for kids with ABSSSI.
    • TEFLARO, a cephalosporin antibiotic administered intravenously, was first approved in October 2010 for the treatment of adults with CABP and ABSSSI.
    | 8:41 AM
  • 8:20 AM
    • Teva Pharmaceutical Industries (NYSE:TEVA) is down 2% premarket on increased volume in response to its announcement that it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) seeking approval of SD-809 for the treatment of chorea (involuntary movements) associated with Huntington's disease, an inherited disorder characterized by the progressive breakdown of nerve cells that leads to movement, cognitive and psychiatric problems.
    • The agency did not request additional clinical trials but wanted the company to re-analyze blood levels of certain metabolites. Teva intends to address the issue as soon as possible and submit its response in Q3.
    • SD-809 (deutetrabenazine) is an orally available small molecule inhibitor of vesicular monoamine 2 transporter (VMAT2) that is designed to regulate the levels of the neurotransporter dopamine in the brain.
    | 8:20 AM
  • 8:02 AM
    • ContraVir Pharmaceuticals (NASDAQ:CTRV) enters into a definitive agreement to acquire all the equity interests in privately held Ciclofilin Pharmaceuticals for the right to receive future development and regulatory milestone payments related to Ciclofilin's lead product candidate, CPI-431-32, a next-generation non-immunosuppressive cyclophilin inhibitor in Phase 1b/2-stage development for the treatment of chronic hepatitis B virus (HBV) infection.
    • The milestone payments will consist of an aggregate of $17M in cash and up to 10% of ContraVir's common stock as of the date of the merger.
    • After the merger, Cicloflilin Founder and CEO Robert Foster, Pharm. D., Ph.D., will join ContraVir as Chief Scientific Officer.
    • CPI-431-32, a non-immunosupressive derivative of cyclosporine, selectively inhibits host cellular enzymes called cyclophilins (Cyp), which are recruited by HBV and other viruses as part of their normal life cycle. CPI-431-32 blocks HBV's ability to hijack CyP and enter liver cells as well as reduces the production of hepatitis B antigens (HBsAg and HBeAg).
    | 8:02 AM | 1 Comment
  • 7:33 AM
    • The European Commission approves the use of IMBRUVICA (ibrutinib) for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL), adding to the original approval in October 2014 for adults with CLL who have received at least one prior therapy or first line in the presence of a 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy or patients with relapsed/refractory mantle cell lymphoma.
    • IMBRUVICA, a Bruton's tyrosine kinase (BTK) inhibitor, is being co-developed by Janssen's Cilag GmbH International (NYSE:JNJ) and AbbVie's (NYSE:ABBV) Pharmacyclics LLC.
    • The FDA approved IMBRUVICA for treatment-naive CLL patients in March.
    | 7:33 AM | 1 Comment
  • 7:24 AM
    | 7:24 AM
  • 7:15 AM
    • Advanced Accelerator (NASDAQ:AAAP): Q1 EPS of -€0.04
    • Revenue of €26.92M (+29.7% Y/Y)
    • Press Release
    | 7:15 AM
  • 7:01 AM
    • As expected, the FDA grants accelerated approval for Intercept Pharmaceuticals' (NASDAQ:ICPT) Ocaliva (obeticholic acid) (OCA), in combination with ursodeoxycholic acid (UDCA), for the treatment of primary biliary cholangitis, formerly known as primary biliary cirrhosis, an autoimmune disease in which the bile ducts in the liver are slowly destroyed.
    • Ocaliva is approved in combination with UDCA in patients who have not responded adequately to UDCA or as monotherapy in patients who cannot tolerate UDCA.
    • In early April, the FDA's Gastrointestinal Drugs Advisory Committee voted 17-0 backing approval.
    • OCA is an agonist of the farnesoid X receptor, a nuclear receptor expressed in the liver and intestine that is a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways.
    • Intercept is up 14% premarket on light volume.
    • Previously: Intercept Pharma up 5% premarket after positive Ad Comm vote (April 8)
    | 7:01 AM | 5 Comments
  • 6:54 AM
    • Medtronic (NYSE:MDT): FQ4 EPS of $1.27 beats by $0.01.
    • Revenue of $7.57B (+3.7% Y/Y) beats by $80M.
    • Press Release
    | 6:54 AM | 1 Comment
  • 6:01 AM
    • uniQure (NASDAQ:QURE): Q1 EPS of -€0.83 misses by €0.10.
    • Revenue of €3.9M (+251.4% Y/Y) beats by €1.22M.
    • Press Release
    | 6:01 AM
  • 3:49 AM
    • Jazz Pharmaceuticals (NASDAQ:JAZZ) is nearing a deal to buy Celator (NASDAQ:CPXX) for $1.5B, or about double its market cap - a huge premium even in biotechnology, where acquirers often pay for promising new drugs.
    • About three months ago, Celator said its Vyxeos treatment helped older high-risk patients with a deadly form of leukemia live longer than those who received the standard of care regimen, sending its stock price soaring.
    • CPXX +78.3% premarket
    • Update: Jazz announces that it will acquire Celator for $30.25 per share in cash or ~$1.5B.
    | 3:49 AM | 13 Comments
  • 2:31 AM
    • Looking to boost its Health Science division, Nestle (OTCPK:NSRGY) has closed a deal worth up to €100M to develop and market an experimental milk allergy test for infants.
    • The Swiss group will pay DBV Technologies €10M upfront for rights to its skin patch test that can detect a cow milk protein allergy, with the balance depending on successful development.
    | 2:31 AM | 1 Comment
  • Monday, May 30, 2016

  • 4:22 AM
    • Already hit by a recession and political turmoil, Brazil has come under more pressure from 150 health experts who have called for the postponement or relocation of the 2016 Olympics in Rio de Janeiro because of the Zika epidemic.
    • The World Health Organization rejected the idea, however, and said that suspending the Olympics or staging them elsewhere would "not significantly alter" the spread of the virus, which is linked to serious birth defects.
    • ETFs: EWZ, BRF, BRZU, EWZS, BZQ, BRAQ, BRAZ, UBR, DBBR, FBZ
    | 4:22 AM | 10 Comments
  • Friday, May 27, 2016

  • 7:18 PM
    • The FDA approves ZINBRYTA (daclizumab) a once-per-month self-administered injectable biologic, co-developed by AbbVie (NYSE:ABBV) and Biogen (NASDAQ:BIIB), for the treatment of adults with relapsing forms of multiple sclerosis (MS).
    • Daclizumab is a new form of humanized monoclonal antibody that selectively binds to interleukin-2 (IL-2) receptor subunit CD25, a protein that is over-expressed on T cells that become abnormally activated in MS. It modulates IL-2 signaling without causing general immune cell depletion.
    • One negative is a boxed warning that daclizumab can cause liver injury. Patients are required to have liver function tests performed prior to starting therapy, before each monthly dose and up to six months after the last dose.
    • ZINBRYTA's approval in the EU is imminent following a positive Ad Comm vote last month.
    • AbbVie and Biogen have co-promotion rights in the U.S. and EU while Biogen has promotional rights elsewhere per the collaboration agreement between Fact Biotech and Biogen. AbbVie entered the picture when it acquired Facet, announced in March 2010, for $450M.
    • Previously: Europe Ad Comm backs AbbVie and Biogen's MS drug Zinbryta (April 29)
    | 7:18 PM | 12 Comments
  • 6:08 PM
    | 6:08 PM
  • 5:13 PM
    • With the aim of regaining compliance with Nasdaq listing requirements, thinly traded nano cap Cyclacel Pharmaceuticals (NASDAQ:CYCC) reverse splits its common stock 1:12 effective at 5:00 pm ET today. Trading in post-split shares will commence on Tuesday, May 31.
    | 5:13 PM
  • 4:56 PM
    • Globus Medical (NYSE:GMED) initiated with Equal Weight Rating and $26 (8% upside) price target by Barclays.
    • TG Therapeutics (NASDAQ:TGTX) initiated with Buy rating $18 (133% upside) price target by SunTrust Robinson Humphrey.
    • Karyopharm Therapeutics (NASDAQ:KPTI) initiated with Outperform rating and $13 (35% upside) price target by Raymond James.
    • SAGE Therapeutics (NASDAQ:SAGE) initiated with Sell rating and $18 (43% downside risk) price target by Chardan Capital.
    • Viking Therapeutics (NASDAQ:VKTX) initiated with Buy rating with a $5 (285% upside) price target by Maxim Group.
    • Fibrocell Science (NASDAQ:FCSC) resumed with Buy rating and $7 (229% upside) price target by Roth Capital Partners.
    • Asterias Biotherapeutics (NYSEMKT:AST) initiated with Buy rating and $5.50 (61% upside) price target by Chardan Capital.
    • Quorum Health (NYSE:QHC) initiated with Market Perform rating and $14 (6% upside) price target by Avondale Partners.
    • Radius Health (NASDAQ:RDUS) initiated with Buy rating and $55 (57% upside) price target by H.C. Wainwright.
    • Johnson & Johnson (NYSE:JNJ) initiated with Sell rating and $94 (17% downside risk) price target by Standpoint Research.
    • NuVasive (NASDAQ:NUVA) upgraded to Overweight from Equal Weight by Barclays. Price target raised to $63 (15% upside) from $58.
    • Zimmer Biomet Holdings (NYSE:ZBH) upgraded to Buy from Hold with a $125 (2% upside) price target by Argus Research.
    • Relypsa (NASDAQ:RLYP) upgraded to Equal Weight from Underweight with a $9 (50% downside risk) price target by Morgan Stanley. To be adjusted after ZS-9 rejection.
    • Ionis Pharmaceuticals (NASDAQ:IONS) downgraded to Market Perform from Outperform by BMO Capital Markets. Price target lowered to $26 (18% upside) from $55.
    • Patterson Companies (NASDAQ:PDCO) downgraded to Hold from Buy by Evercore ISI. Price target lowered to $48.50 (0% upside) from $49.50.
    • United Therapeutics (NASDAQ:UTHR) downgraded to Sell from Hold with a $114 (3% downside risk) price target by Argus Research.
    • Boston Scientific (NYSE:BSX) downgraded to Neutral from Buy with a $24.20 (7% upside) price target by BTIG Research.
    • Neovasc (NASDAQ:NVCN) downgraded to Neutral from Buy by Ladenburg Thalmann. Price target removed.
    | 4:56 PM | 15 Comments
  • 4:24 PM
    • The European Commission approves Strimvelis, an ex-vivo stem cell gene therapy for the treatment of an ultra-rare inherited disorder called Severe Combined Immunodeficiency due to Adenosine Deaminase deficiency (ADA-SCID). Children born with the homozygous disease do not have a fully functioning immune system and are unable to fight off common infections. It affects ~15 European children each year.
    • Strimvelis is only administered once and does not rely on a third party donor. The patient's own bone marrow cells are removed and a vector is used to insert a normal copy of the ADA gene into the cells, which are then reintroduced into the patient via IV infusion. In order to improve the engraftment of the gene-modified cells into the bone marrow, patients are pretreated with low-dose chemo.
    • The data supporting the application was collected from 18 children with ADA-SCID. All participants in the pivotal study (n=12) who received Strimvelis were alive three years post treatment. All the children (n=18) who contributed to the data package are alive today (median follow up of ~seven years). The complete data analysis was recently published in the journal BLOOD.
    • Strimvelis, developed by GlaxoSmithKline (GSK -0.8%) and Italian firms Fondazioine Telethon and Ospedale San Raffaele, is first corrective gene therapy for children to gain regulatory clearance anywhere in the world. It is the second gene therapy approved in the EU, following uniQure's (NASDAQ:QURE) Glybera (alipogene tiparvovec), approved in November 2012 for the treatment of lipoprotein lipase deficiency.
    | 4:24 PM
  • 11:00 AM
    | 11:00 AM
  • 10:27 AM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending the extension of the current conditional approval of Takeda Pharmaceutical's (OTCPK:TKPHF)(OTCPK:TKPYY) ADCETRIS (brentuximab) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplantation (ASCT), an approval first granted in October 2012.
    • ADCETRIS, an antibody-drug conjugate, was co-developed with Seattle Genetics (SGEN +1.3%) who has commercialization rights in the U.S. and Canada. Takeda has commercialization rights elsewhere.
    • A final decision from the European Commission usually takes ~60 days.
    | 10:27 AM
  • 10:08 AM
    • Results from a Phase 3 clinical trial, FALCON, showed AstraZeneca's (AZN -0.4%) FASLODEX (fulvestrant) was superior to Arimidex (anastrozole) in extending progression-free survival (PFS) in postmenopausal women with hormone receptor-positive (HR+) breast cancer who had not had prior hormonal treatment. Full results will be presented at an upcoming medical conference (probably ASCO).
    • FASLODEX is currently approved for the treatment of HR+ HER2- breast cancer, in combination with palbociclib in patients previously treated with endocrine therapy and in HR+ breast cancer in patients previously treated with antiestrogen therapy.
    | 10:08 AM
  • 9:46 AM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of AstraZeneca's (AZN -0.7%) fixed-dose combination of saxagliptin and dapagliflozin for the treatment of adults with type 2 diabetes (T2D).
    • Clinical data supporting the application showed the saxa/dapa combo with metformin statistically significantly reduced HbA1c levels compared to patients treated with placebo that required additional control to existing saxagliptin and metformin or dapagliflozin and metformin therapy. Another study showed the saxa/dapa combo added to metformin produced superior reductions in HbA1c compared to dapagliflozin or saxagliptin alone added to metformin.
    • A final decision from the European Commission usually takes ~60 days.
    • In October 2015, the FDA rejected the company's NDA citing the need for more clinical data.
    • Related tickers: (NYSE:NVO)(NYSE:JNJ)(NYSE:SNY)
    | 9:46 AM
  • 9:27 AM
    • As expected, Shire plc (NASDAQ:SHPG) shareholders voted overwhelmingly in favor of the merger with Baxalta (NYSE:BXLT). At a special meeting, 93.8% of the votes cast, representing 75.5% of Shire's outstanding shares, backed the deal.
    • The positive vote from Baxalta's side was also overwhelmingly in favor with 98.9% of shares backing the marriage.
    • Previously: Shire takes out Baxalta for $32B (Jan. 11)
    | 9:27 AM | 1 Comment
  • 9:13 AM
    • Portola Pharmaceuticals (NASDAQ:PTLA) is up 14% premarket on light volume in response to its announcement of final results from the Phase 3 APEX study assessing extended-duration oral anticoagulant betrixaban compared to Sanofi's (NYSE:SNY) Lovenox (enoxaparin) injection for the prevention of blood clots (venous thromboembolism or VTE) in acute medically ill patients. The data were presented at the 62nd Annual International Society on Thrombosis and Haemostasis Scientific and Standardization Committee Meeting in Montpellier, France.
    • The results showed a consistent and significant reduction in VTE with betrixaban with no statistical difference in major bleeding between the betrixaban and enoxaparin arms. According to the company, over half of VTE events occur after discontinuation of enoxaparin and hospital discharge.
    • Portola intends to file marketing applications in the U.S. and Europe later this year.
    • Previously: Trading in Portola Pharma halted pending news; Phase 3 APEX study of extended-duration betrixaban fails to achieve primary endpoint in first cohort; shares off 24% premarket (March 24)
    | 9:13 AM | 14 Comments
  • 8:43 AM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of AbbVie's (NYSE:ABBV) HUMIRA (adalimumab) for the treatment of adult patients with non-infectious intermediate, posterior and panuveitis who have had an inadequate response to corticosteroids or in whom treatment with corticosteroids in inappropriate.
    • Non-infectious uveitis is a group of diseases characterized by inflammation of the middle layer of the eye called the uvea. It is the third leading cause of preventable blindness worldwide. If approved, HUMIRA will be the first biologic approved for the indication.
    • HUMIRA is currently approved to treat rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis, plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis and hidradenitis suppurativa. It is the world's top selling drug, having generated almost $15B in sales over the most recent four quarters.
    • A final decision from the European Commission usually takes ~60 days.
    | 8:43 AM | 2 Comments
  • 8:30 AM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a negative opinion recommending against approval of Takeda Pharmaceuticals' (OTCPK:TKPHF)(OTCPK:TKPYY) NINLARO (ixazomib) for the treatment of patients with relapsed/refractory multiple myeloma. The company intends to appeal the opinion and request a re-examination of its Marketing Authorization Application (MAA).
    • Takeda says the adverse decision will not affect its 2016 financials.
    • The FDA approved NINLARO in November 2015.
    | 8:30 AM
  • 8:17 AM
    • The European Medicine's Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Merck's (NYSE:MRK) ZEPATIER (elbasvir/grazoprevir) for the treatment of hepatitis C virus (HCV) infection in adults (genotypes are not specified).
    • ZEPATIER is a once-daily, fixed-dose combination of an NS5A inhibitor (elbasvir) and an NS3/4A protease inhibitor (grazoprevir). In January 2016, the FDA approved it for the treatment HCV genotypes 1 and 4, with or without ribavirin.
    • A final decision from the European Commission usually takes ~60 days.
    | 8:17 AM | 4 Comments
  • 8:03 AM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Gilead Sciences' (NASDAQ:GILD) Epclusa (sofosbuvir/velpatasvir) for the treatment of all genotypes of hepatitis C virus (HCV) infection in adults.
    • Epclusa is a once-daily tablet containing sofosbuvir (400 mg), a nucleotide analogue polymerase inhibitor and velpatasvir (100 mg), a pan-genotypic NS5A inhibitor.
    • The data supporting the application was generated in four Phase 3 studies, ASTRAL 1-4, that enrolled 1,035 patients with genotypes 1-6 HCV infection, without cirrhosis or with compensated cirrhosis who received Epclusa for 12 weeks.
    • A final decision from the European Commission usually takes ~60 days.
    • The company's NDA in the U.S. is currently under FDA review. The agency's action date (PDUFA) is June 28.
    | 8:03 AM | 15 Comments
  • 7:46 AM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Amgen's (NASDAQ:AMGN) Kyprolis (carfilzomib), in combination with dexamethasone alone, for the treatment of multiple myeloma (MM) patients who have received at least one prior line of therapy.
    • The data supporting the application was generated in the Phase 3 ENDEAVOR study which showed MM patients treated with Kyprolis + dexamethasone achieved progression-free survival of 18.7 months compared to 9.4 months for those treated with Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) Velcade (bortezomib) plus dexamethasone.
    • Kyprolis is currently approved in the EU in combination with lenalidomide and dexamethasone for the treatment of MM patients who have received at least one prior line of therapy.
    • A final decision from the European Commission usually takes ~60 days.
    | 7:46 AM
  • 7:25 AM
    • In a shot to the corporate solar plexus, AstraZeneca (NYSE:AZN) receives a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) seeking approval of hyperkalemia drug ZS-9 (sodium zirconium cyclosilicate).  In a statement, it said the CRL refers to observations from a pre-approval on-site manufacturing inspection. The agency also cited the receipt of recently-submitted data which it has yet to review. The company is reviewing the CRL to determine appropriate action.
    • AstraZeneca acquired the rights to ZS-9 via its $2.7B acquisition of ZS Pharma in December 2015.
    • Competitor Relypsa (NASDAQ:RLYP) is up 29% premarket on robust volume. Its hyperkalemia drug, Veltassa (patiromer) was approved by the FDA in October 2015.
    • AstraZeneca is down 1% premarket on increased volume.
    | 7:25 AM | 27 Comments
  • 7:17 AM
    • Thermo Fisher Scientific (NYSE:TMO) announces it acquired FEI Company (NASDAQ:FEIC) in a deal valued at $4.2B.
    • The purchase price of $107.50 per FEI share is a 14% premium over the closing price yesterday.
    • FEI designs and manufactures electron microscopy workflow solutions.
    • The transaction is expected to close by early 2017.
    | 7:17 AM
  • 7:15 AM
    • Can-Fite Biopharma (CANF) Q1 results (NIS): Revenues: 0.2M; R&D Expense: 4.1M; SG&A: 2.4M; Operating Loss: (6.2M); Net Loss: (5.8M); Loss Per Share: (0.21); Quick Assets: 56.6M.
    • No guidance given.
    | 7:15 AM
  • 7:05 AM
    • Interim data from a Phase 3 study, GALLIUM, show Genentech's (OTCQX:RHHBY) Gazyva (obinutuzumab) significantly reduced the risk of disease progression or death compared to Rituxan (rituximab) in treatment-naive follicular lymphoma patients. The trial compared the safety and efficacy of Gazyva plus chemo followed by Gazyva alone to Rituxan plus chemo followed by Rituxan alone. Complete results will be presented at an upcoming medical conference (probably ASCO).
    • GALLIUM is a global, open-label, randomized, two-arm study assessing Gazyva and Rituxan for up to two years. Enrollment is 1,401 patients with previously untreated indolent non-Hodgkin's lymphoma of which 1,202 have follicular lymphoma. The primary endpoint is investigator-assessed progression-free survival (PFS) in patients with follicular lymphoma. Secondary endpoints include PFS assessed by independent review committee, PFS in the overall study population, response rate, complete response and overall survival.
    • Adverse events observed were consistent with previous clinical studies.
    • Gazyva (branded as Gazyvaro ex-U.S.), developed with collaboration partner Biogen (NASDAQ:BIIB), is an engineered monoclonal antibody that binds to CD20, a protein expressed on certain types of B cells. It is believed to work by attacking targeted cells both directly and together with the immune system.
    | 7:05 AM
  • 7:05 AM
    • Taro Pharmaceutical (TARO) FQ4 results: Revenues: $265.1M (+8.6%); R&D Expense: $19.9M (-16.7%); SG&A: $22.6M (+1.8%); Operating Income: $181.7M (+18.4%); Net Income: $115M (-24.6%); EPS: $2.68 (-24.7%).
    • FY2016 results: Revenues: $950.8M (+10.2%); R&D Expense: $71.2M (+8.7%); SG&A: $92.4M (+5.5%); Operating Income: $614.5M (+16.5%); Net Income: $541.5M (+11.5%); EPS: $12.63 (+11.6%); Quick Assets: $576.8M (+19.8%); CF Ops: $395.1M (-2.9%).
    • No guidance given.
    | 7:05 AM
  • 7:03 AM
    | 7:03 AM
  • 6:41 AM
    • The European Medicine's Agency's Committee for Medicinal Products for Human Use adopts a positive opinion recommending approval of Shire plc's (NASDAQ:SHPG) Revestive (teduglutide) for the treatment of pediatric patients aged one to 17 years with short bowel syndrome (SBS). Revestive is currently approved in the EU for the treatment of adults with SBS.
    • SBS is a rare gastrointestinal condition characterized by a clinically significant reduction in intestinal absorptive capacity as a result of surgical resection of large portions of the intestine, usually due to congenital abnormalities, disease or trauma.
    • A final decision from the European Commission usually takes ~60 days.
    | 6:41 AM
  • 6:33 AM
    • Aldeyra Therapeutics(NASDAQ:ALDX) prices its public offering of 2.4M shares of common stock at $5 a share. Underwriters over-allotment is an additional 360K shares. Closing date is June 1.
    • Yesterday's close was $5.44.
    | 6:33 AM
  • 6:20 AM
    • Sinovac Biotech (SVA) Q1 results: Revenues: $11M (+19.6%); R&D Expense: $2.1M (-4.5%); SG&A: $6.2M (-8.8%); Operating Loss: ($1.8M) (+10.0%); Net Loss: ($1.6M) (+38.5%); Loss Per Share: ($0.02) (+50.0%); Quick Assets: $62.5M (-2.0%); CF Ops: ($9.5M) (-15.9%).
    • No guidance given.
    | 6:20 AM
  • Thursday, May 26, 2016

  • 10:51 PM
    • Taro Pharmaceutical (NYSE:TARO): FQ4 EPS of $2.68
    • Revenue of $265.1M (+8.6% Y/Y)
    • Press Release
    | 10:51 PM
  • 7:19 PM
    • Valeant Pharmaceuticals (NYSE:VRX) is up 7.1% after hours, following a report from The Wall Street Journal that Takeda (OTCPK:TKPYY) and private-equity firm TPG made a combined takeover approach in recent weeks that the company rejected.
    • No talks are ongoing between the three, though.
    • The approach came before Valeant hired Joseph Papa as its new CEO and didn't get to a firm price.
    • Updated 7:28 p.m.: The board wants to give Papa time to chart a course for the company, sources told the WSJ.
    | 7:19 PM | 133 Comments
  • 6:29 PM
    • Vanda Pharmaceuticals (NASDAQ:VNDA) is up 5% after hours on increased volume in response to its announcement that the FDA has approved its supplemental New Drug Application (sNDA) for the use of Fanapt (iloperidone) as maintenance treatment for adults with schizophrenia.
    • The data supporting the application was generated in the REPRIEVE study which showed 79.6% of patients treated with Fanapt remained relapse-free compared to 36.6% for placebo.
    • The FDA first approved Fanapt in May 2009 for the short-term treatment of schizophrenia in adults.
    | 6:29 PM
  • 6:16 PM
    • The Medicines Company (NASDAQ:MDCO) completes the enrollment of ~550 patients in its Phase 3 clinical trial, TANGO 1, assessing Fast Track-tagged CARBAVANCE (meropenem-vaborbactam) for the treatment of complicated urinary tract infections (cUTI). The primary endpoint is the efficacy at the end of IV treatment (day 5-14) or at test-of-cure visit (day 15-23) compared to piperacillin/tazobactam.. According to clinicaltrials.gov, the estimated study completion date is next month. Top-line data should be released in H2.
    • Study participants have been randomized 1:1 to receive either IV CARBAVANCE or IV piperacillin/tazobactam for up to 10 days. Patients who achieve protocol-defined criteria for improvement can be switched to oral levofloxacin after a minimum of five days of IV therapy.
    • CARBAVANCE is a combination of meropenem, a broad spectrum antibiotic, and vaborbactam (formerly RPX7009), a beta lactamase inhibitor, that is administered via IV infusion for the treatment of serious gram-negative infections like cUTI.
    • The FDA designated CARBAVANCE a Qualified Infectious Disease Product (QIDP) for cUTI, intra-abdominal infections, hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia and febrile neutropenia in January 2014. Among the benefits of QIDP status is an additional five-year period of market exclusivity for the indications, if approved.
    | 6:16 PM
  • 6:02 PM
    • Sinovac Biotech (NASDAQ:SVA): Q1 EPS of -$0.02
    • Revenue of $10.95M (+19.0% Y/Y)
    • Press Release
    | 6:02 PM
  • 5:52 PM
    • Walgreens Boots Alliance (NASDAQ:WBA) prices its $6B offering of unsecured unsubordinated notes. The tranches are:
    • $1.25B 1.750% notes due 2018; $1.5B 2.600% notes due 2021; $750M 3.100% notes due 2023; $1.9B 3.450% notes due 2026 and $600M 4.650% notes due 2046.
    • Net proceeds will fund a portion of the cash consideration in the Rite Aid deal, the retirement of a portion of Rite Aid's debt and related fees and expenses. Any remaining proceeds will be used for general corporate purposes. Closing date is June 1.
    | 5:52 PM | 5 Comments
  • 5:41 PM
    • Intellipharmaceutics (NASDAQ:IPCI) commences a public offering of stock and warrants. Price, volume and terms have yet to be announced.
    | 5:41 PM | 1 Comment
  • 5:31 PM
    • SAGE Therapeutics (NASDAQ:SAGE) hits its enrollment target of ~32 patients in its proof-of-concept Phase 2 clinical trial assessing lead product candidate SAGE-547 for the treatment of women with severe postpartum depression (PPD). The primary endpoint is the change from baseline in PPD compared to placebo as determined by the total score of a metric called the Hamilton Rating Scale for Depression (HAM-D). Study participants had a HAM-D score of at least 26 (very severe depression; 0-7=normal) prior to treatment and were less than six months postpartum.
    • According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is June 2016. The estimated study completion date is July 2016 which is also the expected time to release top-line data.
    • Complete results will be presented at a future medical conference.
    • SAGE-547 is an allosteric modulator of both synaptic (junction between nerve cells) and extra-synaptic GABAa receptors. When activated, GABAa receptors cause the neuron to hyperpolarize which inhibits neurotransmission.
    | 5:31 PM
  • 5:09 PM
    • The FDA approves CSL Behring's AFSTYLA [Antihemophilic Factor (Recombinant) Single Chain], its long-acting recombinant factor VIII single-chain therapy for the treatment of adults and children with hemophilia A.
    • AFSTYLA is indicated for routine prophylaxis to reduce the frequency of bleeding episodes with dosing of two-to-three times per week, on-demand treatment and control of bleeding episodes and the perioperative management of bleeding.
    • Market launch will commence this summer.
    • Hemophilia A-related tickers: (NYSE:BXLT)(OTCPK:BAYRY)(NASDAQ:BMRN)(NYSE:OPK)(NYSE:SNY)(NASDAQ:ALNY)(NASDAQ:BIIB)(NASDAQ:SGMO)(OTCQX:RHHBY)(NASDAQ:CBIO)
    | 5:09 PM | 5 Comments
  • 4:37 PM
    • Struggling nutrition products maker MusclePharm (OTCQB:MSLP) continues to make headway in its restructuring efforts, eliminating $45M in future financial obligations, including a reduction of $39.5M by exiting certain sponsorship and endorsement agreements (includes Tiger and Arnold).
    • Other developments include a deal with Prestige Capital to use receivables to finance up to $10M and the previously announced divestiture of BioZone Labs for up to $9.8M.
    | 4:37 PM | 33 Comments
  • 4:27 PM
    • The FDA approves Titan Pharmaceuticals' (NASDAQ:TTNP) buprenorphine implant for the maintenance treatment of opioid dependence. The product, consisting of four one-inch-long rods that are implanted under the skin on the inside of the upper arm, is designed to deliver a constant low dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of buprenorphine as part of their treatment program.
    • Privately held Braeburn Pharmaceuticals will commercialize.
    | 4:27 PM | 32 Comments
  • 2:51 PM
    | 2:51 PM
DJIA (DIA) S&P 500 (SPY)
ETF Hub
ETF Screener: Search and filter by asset class, strategy, theme, performance, yield, and much more
ETF Performance: View ETF performance across key asset classes and investing themes
ETF Investing Guide: Learn how to build and manage a well-diversified, low cost ETF portfolio
ETF Selector: An explanation of how to select and use ETFs