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Nov. 4, 2015, 6:32 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN): Q3 EPS of $3.47 beats by $0.27.
- Revenue of $1.14B (+57.1% Y/Y) beats by $90M.
Nov. 3, 2015, 5:30 PM
- AFAM, AGN, AMRN, ARCC, ARCO, ARQL, ARRY, AVA, AVP, AXAS, BDX, BIOS, BSFT, CBB, CDW, CECO, CHK, CLH, CRK, CRL, CRTO, CRZO, CST, CSTE, CTSH, DAVE, DDD, EE, EMES, FOR, FOXA, GDP, HAE, HEP, HMC, HSIC, HSNI, INXN, KELYA, KORS, LINC, LL, MEMP, MFA, MNTA, MSI, MWE, NAVB, NCT, NEWP, NRG, NYLD, REGN, SBGI, SCMP, SE, SHOP, SNH, SODA, SSYS, STNG, TESO, TMHC, TWX, USAK, VG, VOYA, VRTU, VSI, WCG, WD, WEC, WEN, WILN, WIX, WMC
Nov. 3, 2015, 12:25 PM
- Regeneron Pharmaceuticals (REGN -0.7%) will report Q3 results tomorrow before the open. Consensus view is EPS of $3.20 (+27.0%) on revenues of $1.05B (+44.6%).
Oct. 30, 2015, 9:24 AM
- The European Commission approves EYLEA (aflibercept) for the treatment of visual impairment due to myopic choroidal neovascularization, a disease of the retina associated with a high degree of myopia (near-sightedness). Bayer (OTCPK:BAYRY), co-developing EYLEA with Regeneron Pharmaceuticals (NASDAQ:REGN), plans to immediately launch the new application in Germany.
- EYLEA was previously approved for wet age-related macular degeneration and visual impairment due to diabetic macular edema and macular edema secondary to retinal vein occlusion.
Oct. 26, 2015, 5:24 PM
- Ophthotech (NASDAQ:OPHT) hits its enrollment target in its second Phase 3 clinical trial evaluating Fast Track-tagged Fovista (pegleranib), in combination with Roche's (OTCQX:RHHBY) Lucentis (ranibizumab), for the treatment of wet age-related macular degeneration (wet AMD). Top-line data from both studies are expected in Q4 2016.
- CEO David Guyer, M.D., says, "Completion of patient recruitment in these two large scale Phase 3 clinical trials of [Fovista] in combination with Lucentis is a significant milestone in the Fovista Phase 3 pivotal program. We believe that Fovista, administered in combination with anti-VEGF therapy, may represent a significant advancement in the treatment of wet AMD and we look forward to obtaining data from both of these studies."
- A third Phase 3 study assessing Fovista in combination with either Regeneron (NASDAQ:REGN) and Bayer's (OTCPK:BAYRY) Eylea (aflibercept) or Roche's Avastin (bevacizumab) continues to enroll participants.
- Fovista is an anti-platelet-derived growth factor (anti-PDGF) agent.
- Previously: Ophthotech moving ahead with Fovista studies (May 11)
Oct. 12, 2015, 8:38 AM
- Eli Lilly (NYSE:LLY) is down 10% premarket on robust volume in response to its announcement that it has terminated the development of evacetrapib for the treatment of high-risk atherosclerotic cardiovascular disease due to lack of efficacy. Its decision was based on a review by the independent data monitoring committee.
- The move will result in a Q4 charge to R&D expense of up to $90M ($0.05 per share after tax). The company will incorporate the change in its 2015 guidance that it will provide during its earnings call on October 22.
- SVP and President of Lilly Bio-Medicines David Ricks says, "We're obviously disappointed in this outcome, as we hoped the evacetrapib would offer an advance in treatment for people with high-risk cardiovascular disease. We'll be working with investigators to appropriately conclude these trials. We remain confident in our pipeline as we prepare for launches in other therapeutics areas with significant unmet needs."
- Related tickers and status premarket: (NASDAQ:REGN) +4%; (NASDAQ:AMGN) +3%; (NASDAQ:ESPR) +14%; (NYSE:SNY) +1%.
Oct. 9, 2015, 10:15 AM
- Gilead Sciences (GILD +0.5%) downgraded to Equal Weight from Overweight by Morgan Stanley. Price target maintained at $127 (27% upside).
- Valeant Pharmaceuticals (VRX +3.3%) downgraded to Equal Weight from Overweight by Morgan Stanley. Price target lowered to $200 (14% upside) from $284.
- Mead Johnson (MJN +0.7%) downgraded to Underperform from Neutral by BofA Merrill Lynch. Price target lowered to $78 (7% upside) from $80.
- Ilumina (ILMN +1.9%) downgraded to Neutral from Buy by Mizuho Securities. Price target lowered to $150 (5% upside) from $250.
- Chimerix (CMRX +1.7%) downgraded to Equal Weight from Overweight by Morgan Stanley. Price target lowered to $50 (34% upside) from $56.
- Regeneron Pharmaceuticals (REGN +0.6%) downgraded to Equal Weight from Overweight with a price target of $593 (20% upside) by Morgan Stanley.
- Diplomat Pharmacy (DPLO +1.1%) downgraded to Equal Weight from Overweight by Morgan Stanley. Price target lowered to $31 (24% upside) from $58.
- AmerisourceBergen (ABC -0.3%) downgraded to Equal Weight from Overweight by Morgan Stanley. Price target lowered to $93 (0% upside) from $120.
Oct. 6, 2015, 6:44 PM
- Leading pharmacy benefits manager Express Scripts (ESRX -1%) has settled an investor debate about which pricey cholesterol drug it will cover -- by saying it will cover both of them.
- Praluent, from Regeneron (REGN -2.9%) and Sanofi (SNY -0.7%), and Repatha, from Amgen (AMGN -1.8%), will both be included on Express Scripts' formulary. Each of the PCSK9 inhibitors is at least $14,000/year, significantly higher than the cost of now-generic statins, though more effective.
- The drugs are injectables that dramatically lower LDL (the "bad cholesterol").
- Express Scripts has said that the drugs won't be "budget busters," and that most prescriptions are getting rejected because patients don't meet medical criteria.
- In after-hours action: ESRX flat; REGN +0.1%; SNY +0.8%; AMGN flat.
Oct. 2, 2015, 11:44 AM
- House Democrats' keen interest in certain drug firms' pricing strategies prompted Morgan Stanley's David Risinger to downgrade Valeant Pharmaceuticals (VRX -3.2%) to Equal Weight from Overweight with a price target of $200 (14% upside) citing the large contribution (14%) that price increases have to its top-line growth.
- He also downgraded Regeneron Pharmaceuticals (REGN -0.2%) to Equal Weight with a price target of $593 (26% upside) citing potential headwinds created by competitors, including an anticipated tough fight with Amgen (Praluent vs. Repatha). Gilead Sciences (GILD -1.3%) got a haircut to Equal Weight with a price target of $127 (31% upside) citing slowing Hep C volume growth.
- Mr. Risinger also slapped AmerisourceBergen (ABC -1.3%) with an Underweight (Sell) rating due to its reliance on branded drug price inflation. He cut his price target to $93 (0% upside) from $120.
Oct. 1, 2015, 4:38 PM
- Regeneron Pharmaceuticals (NASDAQ:REGN) grants exclusive development and commercial rights to its Nerve Growth Factor (NGF) antibody, fasinumab, to Mitsubishi Tanabe Pharma for the territory of Japan, Korea and nine other Asian countries, excluding China. Fasinumab is in late-stage development for the treatment of musculoskeletal pain.
- Under the terms of the agreement, Regeneron will receive an upfront payment of $55M as well as other near-term payments. It will also be eligible to receive up to $170M in R&D reimbursement payments and development milestones, a portion of the profits and additional one-time purchase price adjustment payments of up to $100M upon the achievement of certain annual sales targets.
Sep. 30, 2015, 12:49 PM
- Bruised and battered biotech investors get some welcome buying today as bargain hunters open their wallets. The iShares Nasdaq Biotech Index Fund (IBB +2%) is up nicely, albeit on average volume.
- Key tickers: (AMGN +1.6%)(BIIB +2.5%)(GILD +1%)(CELG +0.7%)(DEPO +12.4%)(HZNP +8.6%)(NVO +0.7%)(AGN +4.9%)(VRX +6.4%)(REGN +0.9%)(TEVA +2%)(SHPG +2.6%)
Sep. 28, 2015, 7:03 AM
- As expected, the European Commission (EC) approves Praluent (alirocumab) for lowering low-density lipoprotein (LDL) cholesterol in certain adults with hypercholesterolemia. The approval follows CHMP's positive opinion in July. Praluent, co-developed by Sanofi (NYSE:SNY) and Regeneron Pharmaceuticals (NASDAQ:REGN), will be available in a single-dose (75 mg or 150 mg) pre-filled pen that patients can self-administer.
- The EC approved Amgen's (NASDAQ:AMGN) Repatha (evolocumab) in July.
- Previously: Amgen's Repatha cleared in Europe (July 21)
- Previously: Europe's CHMP give thumbs up to Regeneron and Sanofi's Praluent (July 24)
Sep. 27, 2015, 8:59 AM
- The $8B iShares Nasdaq Biotechnology ETF (NASDAQ:IBB) fell 4.9% on Friday and 13% for the week - its worst weekly performance since the height of the financial panic seven years ago. Many biotech ETFs eat the same cooking - Gilead (NASDAQ:GILD), Amgen (NASDAQ:AMGN), Biogen (NASDAQ:BIIB), and Regeneron (NASDAQ:REGN) among the popular names - and FBT, XBI, and BBP fell in amounts similar to IBB.
- The news flow was relatively quiet late in the week, but Hilary Clinton's promise Monday to clamp down on drug prices set things in negative motion for the momo sector.
- Barron's Chris Dieterich reminds that a flood of biotech IPOs in recent years has filled the small cap universe with these highly speculative names, and biotech now makes up 7% of the iShares Russell 2000 Index (NYSEARCA:IWM). Indeed. The IWM fell 3.7% for the week, nearly tripling the decline of the S&P 500.
- ETFs: IWM, TZA, TNA, UWM, VB, VBK, URTY, SCHA, TWM, IWO, RWM, SRTY, VTWO, RCG, JKJ, VTWG, TWOK, FYX, JKK, EWRS, ZSML, FYC, SMLL, RYRSX
Sep. 21, 2015, 6:52 PM
- Wynn Resorts (NASDAQ:WYNN), Viacom (NASDAQ:VIAB) and Dollar Tree (NASDAQ:DLTR) headline Goldman Sachs' list of 25 companies that could post outsized returns even as more and more stocks are moving in lock-step.
- Goldman’s picks come as return dispersion - the performance gap among stocks - has sunk lately amid turmoil in China and concerns about when the Fed will raise interest rates that has pushed stock correlations to their highest level since 2011.
- Given the low-dispersion setting, Goldman says investors should focus on these 25 stocks that have high “dispersion scores” and 15%-plus upside to the firm’s targets: WYNN, VIAB, DLTR, UAL, LUV, URBN, CBG, JNPR, MPC, NFLX, HBI, SIG, CRM, CERN, VLO, KMX, ENDP, CTSH, ISRG, ETFC, TSN, CCE, CI, REGN, GT
Sep. 21, 2015, 8:27 AM
- The U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) will provide $17M in initial funding to Regeneron Pharmaceuticals (NASDAQ:REGN) to develop, test and manufacture a treatment for Ebola infection including an IND filing with the FDA. An option in the agreement provides for an additional $21M to fund a Phase 1 study in health volunteers, planned for January 2016, and further manufacturing and development studies.
- The product candidate is a monoclonal antibody developed with the company's VolociGene and VelocImmune technologies. Sanofi (NYSE:SNY) has opt-in rights pursuant to its 2009 antibody discovery and development agreement with Regeneron.
Sep. 11, 2015, 9:39 AM
- Amgen (AMGN -0.8%) files an application with the FDA seeking clearance for a single once-per-month 420 mg injection of its cholesterol fighter Repatha (evolocumab). Presently, Repatha is available in a single-use 140 mg/mL prefilled autoinjector which requires three subcutaneous injections for a dose of 420 mg. One injection, obviously, would be much more patient-friendly for those patients requiring/preferring a once-per-month regimen.
- The FDA cleared Repatha, a PCSK9 inhibitor, on August 27, for lowering LDL-C (bad cholesterol).
- Sanofi (SNY -0.2%) and Regeneron's (REGN -0.4%) Praluent (alirocumab), Reptha's competitor, requires a subcutaneous injection every two weeks via a pre-filled syringe/pen.
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