Regeneron Pharmaceuticals, Inc. (REGN) - NASDAQ
  • Jun. 10, 2015, 10:25 AM
    • Esperion Therapeutics (ESPR -24%) drops on a 3x surge in volume as investors apparently perceive more modest prospects for the company's cholesterol-lowering drug candidate, ETC-1002, after yesterday's positive Ad Comm vote for Regeneron (REGN -4.9%) and Sanofi's (SNY +0.7%) Praluent (alirocumab), which is now poised for approval sometime this summer.
    • UBS analyst Andrew Peters remains undeterred. He maintains his Buy rating and $140 price target.
    • Previously: Esperion cholesterol-lowering drug candidate successful in Phase 2 study (March 17)
    | Jun. 10, 2015, 10:25 AM | 20 Comments
  • Jun. 10, 2015, 8:41 AM
    • Regeneron Pharmaceuticals (NASDAQ:REGN) slumps 4% premarket on light volume in response to yesterday's Ad Comm vote on its cholesterol-lowering med Praluent (alirocumab), co-developed with Sanofi (NYSE:SNY).
    • The committee voted 13-3 in favor of approval, but only in combination with a statin or as monotherapy in patients who cannot tolerate statins. Ideally, the vote would have supported the use of alirocumab as unconditional monotherapy.
    • SNY is up a fraction premarket on modest volume.
    | Jun. 10, 2015, 8:41 AM | 3 Comments
  • Jun. 9, 2015, 6:51 PM
    • Regeneron (NASDAQ:REGN) has reopened for trading, up 1.1% to $532, after an FDA Ad Comm ruling in favor of its and Sanofi's Praluent (alirocumab) cholesterol-lowering drug.
    • Shares had been halted since just before 7 a.m.
    • The vote was 13-3. On Wednesday, the committee turns its attention to Amgen's (NASDAQ:AMGN) drug evolocumab.
    • Sanofi estimates that 11M Americans might qualify for the drugs, which could run up to $10K/year in cost. Amgen estimates that 8M Americans might qualify.
    | Jun. 9, 2015, 6:51 PM | 13 Comments
  • Jun. 9, 2015, 5:10 PM
    | Jun. 9, 2015, 5:10 PM | 2 Comments
  • Jun. 9, 2015, 7:20 AM
    • The Nasdaq suspends trading in Regeneron Pharmaceuticals (NASDAQ:REGN) today while FDA's Endocrinologic and Metabolic Drugs Advisory Committee meets to discuss the New Drug Application (NDA) for Praluent (alirocumab), co-developed with Sanofi (NYSE:SNY).
    | Jun. 9, 2015, 7:20 AM
  • Jun. 5, 2015, 11:02 AM
    • The FDA's Endocrinologic and Metabolic Drugs Advisory Committee meets Tuesday, June 9 to discuss the Biologics License Application (BLA) submitted by Sanofi (SNY -2.7%) seeing approval for Praluent (alirocumab) for the treatment of adult patients with high cholesterol (hypercholesterolemia) or mixed dyslipidemia to reduce low-density lipoprotein cholesterol (LDL-C) as monotherapy or in combination with a statin. Sanofi and Regeneron Pharmaceuticals (REGN +1.9%) co-developed Praluent.
    • FDA Briefing doc
    • Sanofi/Regeneron briefing doc
    • Addendum to Sanofi/Regeneron briefing doc
    • The committee will review Amgen's (AMGN +0.1%) BLA for Repatha on Wednesday, June 10 (briefing docs not yet posted).
    | Jun. 5, 2015, 11:02 AM | 3 Comments
  • Jun. 5, 2015, 9:23 AM
    • Amgen (NASDAQ:AMGN) announces the completion of enrollment of ~27,500 patients in the Phase 3 study, called FOURIER, assessing whether treatment with Repatha (evolocumab) reduces the risk of cardiovascular (CV) events in patients with high cholesterol and clinically relevant CV disease. The trial will compare Repatha in combination with statin therapy to placebo plus statin therapy. Results are expected no later than 2017.
    • Evolocumab is an investigational fully human monoclonal antibody that inhibits convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C) from the blood.
    • PCSK9 inhibitors are posed to dominate the post-statin cholesterol-lowering market. Amgen is neck-and-neck with Regeneron (NASDAQ:REGN) and Sanofi's (NYSE:SNY) Praluent (alirocumab). Europe's CHMP recommended Repatha for approval several weeks ago. A final decision by the European Commission usually takes ~60 days. The EMA accepted the MAA for Praluent in January 2015. An FDA advisory committee will meet on June 9 to discuss Praluent's BLA and June 10 to discuss Rapatha's. The PDUFA date for Repatha is August 27 while Praluent's is July 24.
    | Jun. 5, 2015, 9:23 AM | 4 Comments
  • May 26, 2015, 9:21 AM
    • The FDA approves privately-held Boehringer Ingelheim's once-daily Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray for the maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is not cleared for the treatment of asthma or acute deterioration of COPD.
    • Tiotropium, a long-acting anticholinergic, is the active ingredient in Spiriva, the most prescribed COPD maintenance treatment worldwide. Olodaterol, a long-acting beta2-agonist that complements the efficacy of Spiriva, has a fast onset of action that improves airflow in five minutes after dosing.
    • COPD-related tickers: (NASDAQ:TBPH) (NYSE:GSK) (NASDAQ:THRX) (NYSE:AZN) (NYSE:NVS) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY) (NASDAQ:AQXP)
    | May 26, 2015, 9:21 AM | 2 Comments
  • May 21, 2015, 9:30 AM
    • Alongside Goldman's list of 50 stocks appearing most as top holdings at hedge funds is its list of the 50 top shorts.
    • New additions this quarter: Baxter Intl (NYSE:BAX), UPS, Marriott (NASDAQ:MAR), NextEra (NYSE:NEE), Ford (NYSE:F), National Oilwell Varco (NYSE:NOV), McDonald's (NYSE:MCD), M&T Bank (NYSE:MTB), CenturyLink (NYSE:CTL), Amgen (NASDAQ:AMGN), Pioneer Natural (NYSE:PXD), Duke Energy (NYSE:DUK), Seagate (NASDAQ:STX), AbbVie (NYSE:ABBV), Cisco (NASDAQ:CSCO).
    • The full list (in order of $ value of short interest): AT&T (NYSE:T), Disney (NYSE:DIS), IBM, Verizon (NYSE:VZ), Intel (NASDAQ:INTC), Kinder Morgan (NYSE:KMI), Exxon (NYSE:XOM), Pfizer (NYSE:PFE), J&J (NYSE:JNJ), Deere (NYSE:DE), Caterpillar (NYSE:CAT), Exelon (NYSE:EXC), GE, Boeing (NYSE:BA), Halliburton (NYSE:HAL), Fox (NASDAQ:FOXA), Comcast (NASDAQ:CMCSA), UTX, Regeneron (NASDAQ:REGN), Merck (NYSE:MRK), salesforce.com (NYSE:CRM), AbbVie (ABBV), Conoco (NYSE:COP), Wal-Mart (NYSE:WMT), Eli Lilly (NYSE:LLY), Celgene (NASDAQ:CELG), Schlumberger (NYSE:SLB), AutoZone (NYSE:AZO), Wells Fargo (NYSE:WFC), Emerson (NYSE:EMR), McDonald's (MCD), Reynolds (NYSE:RAI), Target (NYSE:TGT), Accenture (NYSE:ACN), Coca-Cola (NYSE:KO).
    | May 21, 2015, 9:30 AM | 76 Comments
  • May 21, 2015, 7:51 AM
    • A Phase 3 clinical trial, called SARIL-RA-TARGET, evaluating the investigational fully human IL-6 receptor antibody sarilumab in patients with rheumatoid arthritis (RA) who were inadequate responders to or intolerant of TNF-alpha inhibitors (TNF-IR) achieved its co-primary endpoints. The study compared two subcutaneous doses of sarilumab versus placebo, added to non-biologic disease-modifying anti-rheumatic (DMARD) therapy (e.g., methotrexate) in 546 patients.
    • Subjects were randomized in three treatments groups that self-administered either sarilumab 200 mg, 150 mg or placebo every other week, in addition to DMARD therapy.
    • The co-primary endpoints were: 1) proportion of patients with improvement in signs and symptoms of RA measured by ACR20 score (American College of Rheumatology score of 20% improvement in symptoms) at week 24 and 2) improvement in physical function measured by change from baseline in the Health Assessment Question-Disability Index at week 12.
    • The results in the three treatment arms (200 mg, 150 mg, placebo) relative to the first endpoint were 61%, 56% and 34%, respectively. The specific results for the second endpoint are not reported but both test arms showed clinically relevant and statistically significant improvements compared to placebo (p>0.001).
    • Detailed results from the study, along with results from two other trials, SARIL-RA-EASY and SARIL-RA-ASCERTAIN, will be presented at future medical conferences.
    • Sarilumab, developed with Regeneron Pharmaceuticals' (NASDAQ:REGN) VelocImmune antibody technology, binds to IL-6, a protein that plays a key role in inflammation. It is being co-developed with Sanofi (NYSE:SNY) under their collaboration that began in 2007.
    | May 21, 2015, 7:51 AM
  • May 20, 2015, 1:14 PM
    • Thinly traded nano cap Lpath (LPTN -79.5%) craters on a massive 78x surge in volume in response to its announcement that its lead product candidate, iSONEP, failed to achieve its primary and key secondary efficacy endpoints in a Phase 2 trial in patients with wet age-related macular degeneration (wet AMD) who had not responded adequately to anti-vascular endothelial growth factor (VEGF) therapies such as Roche's (OTCQX:RHHBY -0.4%) Lucentis (ranibuzumab) or Avastin (bevacizumab) or Regeneron's (REGN +1.4%) Eylea (aflibercept).
    • Patients treated with iSONEP, either alone or as an adjunct, did not show any statistically significant improvement in visual acuity.
    • SVP and Chief Development Officer Dario Paggiarino, M.D., says, "This trial was designed to evaluate the activity of iSONEP in wet AMD patients that had previously received at least three prior injections of an anti-VEGF agent and had not responded well. While the primary endpoint of the trial was not met, we will be conducting a complete analysis of the data, including additional anatomical endpoints, to better understand the results from each arm of the trial."
    • iSONEP is a monoclonal antibody that binds to a bioactive lipid called sphingosine-1-phosphate, a major regulator of vascular systems.
    • Final results will be presented in November at the American Academy of Ophthalmology meeting in Las Vegas, NV.
    • Related ticker: (PFE +0.4%)
    | May 20, 2015, 1:14 PM | 7 Comments
  • May 11, 2015, 5:22 PM
    • Ophthotech (NASDAQ:OPHT) completes enrollment in its first Phase 3 trial assessing Fovista (anti-PDGF BB pegylated aptamer) in combination with Roche's (OTCQX:RHHBY) Lucentis (ranibizumab) compared to Lucentis alone as monotherapy in patients with wet age-related macular degeneration (wet-AMD).
    • Patient enrollment in a second Phase 3 study assessing Fovista + Lucentis compared to Lucentis alone should be completed by the end of Q3. Data readout from the first two studies should happen in 2016.
    • A third Phase 3 study evaluating Fovista in combination with Regeneron's (NASDAQ:REGN) Eylea (aflibercept) or Roche's Avastin (bevacizumab) compared to Eylea or Avastin alone should reach its enrollment target in the same time frame as the other two studies, although the expected time from today is unclear.
    • Total enrollment in the three trials will be ~1,866 across 225 sites worldwide.
    • The company's objective with Fovista is to be agnostic relative to the choice of anti-VEGF agent co-administered with it.
    | May 11, 2015, 5:22 PM | 5 Comments
  • May 7, 2015, 8:04 AM
    • Regeneron Pharmaceuticals (NASDAQ:REGN) Q1 results ($M): Revenues: 869.6 (+39.0%); Net Product Sales: 544.6 (+50.3%); Sanofi Collaboration Revenue: 173.4 (+28.4%); Bayer Healthcare Collaboration Revenue: 123.8 (-1.2%); Technology Licensing/Other: 27.8 (+270.7%); Operating Income: 283.6 (+48.0%); Net Income: 76.0 (+11.3%); EPS: 0.66 (+8.2%); Quick Assets: 1,225.5 (-10.0%).
    • Eylea U.S. sales: 541 (+50.7%); ex-U.S. sales: 292 (+33.9%).
    • 2015 Guidance: Eylea U.S. net product sales growth: 30 - 35% from 25 - 30%.
    | May 7, 2015, 8:04 AM | 1 Comment
  • May 7, 2015, 6:31 AM
    • Regeneron Pharmaceuticals (NASDAQ:REGN): Q1 EPS of $2.88 beats by $0.20.
    • Revenue of $870M (+39.0% Y/Y) beats by $45.36M.
    | May 7, 2015, 6:31 AM | 3 Comments
  • Apr. 29, 2015, 10:05 AM
    • The FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet on June 10 to discuss Amgen's (AMGN +0.2%) Biologics License Application (BLA) for Repatha (evolocumab) for the treatment of high cholesterol. The FDA's PDUFA date is August 27.
    • Evolocumab is an inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C) (the "bad" cholesterol) from the blood. It, along with Regeneron's (REGN +0.8%) Praluent (alirocumab), are the front-runners to dominate the post-statin cholesterol-lowering market. Praluent's PDUFA date is July 24. Both drugs should be blockbusters.
    • Previously: Evolocumab successful in two Phase 3 studies (Oct. 2, 2014)
    • Previously: Regeneron's alirocumab shows durable effect in lowering "bad" cholesterol in high risk patients (March 16)
    | Apr. 29, 2015, 10:05 AM | 1 Comment
  • Mar. 25, 2015, 11:21 AM
    • The FDA approves the use of Regeneron Pharmaceuticals' (REGN -3%) Eylea (aflibercept) for the treatment of diabetic retinopathy (DR) in patients with diabetic macular edema (DME).
    • Diabetic retinopathy is the most common diabetic eye disease and the leading cause of blindness in adults in the U.S., affecting more than 29M Americans. About a third of diabetics over the age of 40 have some form of DR. In some cases of DR with DME, abnormal new blood vessels grow on the surface of the retina. If they break, severe vision loss or blindness can occur.
    • The FDA previously cleared Eylea for the treatment of wet age-related macular degeneration, DME and macular edema secondary to retinal vein occlusions.
    • Eylea generates the bulk of the company's sales, pulling in $1.7B last year (62% of total revenues).
    | Mar. 25, 2015, 11:21 AM | 1 Comment
Company Description
Regeneron Pharmaceuticals, Inc. operates as a biopharmaceutical company. It discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. The company involves in marketing medicines for eye diseases, colorectal cancer and a rare... More
Sector: Healthcare
Industry: Biotechnology
Country: United States