What's your position on ?
Why are you ish?
You voted ish on Vote again
Posts appear on the My Feed page of subscribers to this ticker
Jun. 9, 2015, 5:10 PM
- The FDA's Endocrinologic and Metabolic Drugs Advisory Committee votes 13-3 recommending approval of Praluent (NYSE:SNY) (NASDAQ:REGN) (alirocumab).
- Previously: Ad Comm approaches for Sanofi/Regeneron cholesterol-lowering med (June 5)
- Previously: Regeneron's alirocumab shows durable effect in lowering "bad" cholesterol in high risk patients (March 16)
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, 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.
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 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, 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 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 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 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, 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.
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)
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. 23, 2015, 4:26 PM
- According to Thomson Reuters' 2015 Drugs to Watch report, as many as 11 blockbuster drugs (peak sales of at least $1B within five years) are expected to clear the regulatory process this year. This is a significant jump from 2014's tally of three (Gilead's (NASDAQ:GILD) Sovaldi and Zydelig; Glaxo (NYSE:GSK) and Theravance's (NASDAQ:THRX) Anoro Ellipta). In reverse order (forecasted 2019 consensus sales in parentheses):
- 11. Novartis' (NYSE:NVS) Cosentyx (secukinumab) for psoriasis and psoriatic arthritis ($1.08B); 10. Sanofi's (NYSE:SNY) Toujeo (insulin glargine) for diabetes ($1.26B); 9. Otsuka Pharmaceutical (OTCPK:OTSKY) and Lundbeck's (OTCPK:HLUYY) Brexpiprazole for schizophrenia and depression ($1.35B); 8. Merck's (NYSE:MRK) Gardisil 9 HPV vaccine ($1.64B); 7. Amgen's (NASDAQ:AMGN) evolocumab for hypercholesterolemia/hyperlipidemia ($1.86B); 6. AbbVie's (NYSE:ABBV) Veikira Pak for hepatitis C (cleared 12/19/14) ($2.5B); 5. Vertex Pharmaceuticals' (NASDAQ:VRTX) lumacaftor plus ivacaftor for cystic fibrosis ($2.74B); 4. Pfizer's (NYSE:PFE) Ibrance (palbociclib) for breast cancer ($2.76B); 3. Novartis' LCZ696 for chronic heart failure ($3.73B); 2. Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) for hypercholesterolemia ($4.41B) and 1. Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) for melanoma ($5.68B).
Mar. 18, 2015, 7:45 AM
- Two 24-week Phase 3 trials (PINNACLE 1 & 2) evaluating AstraZeneca's (NYSE:AZN) PT003 in patients with chronic obstructive pulmonary disease (COPD) achieved their primary efficacy endpoints of statistically significant improvement in lung function compared to placebo.
- PT003 is a twice-daily fixed-dose combination of glycopyrronium, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta-2 agonist (LABA). It is the first LAMA/LABA combination to be delivered in a pressurized metered dose inhaler using the porous particle co-suspension technology developed by Pearl Therapeutics, which AZN acquired in 2013. The successful outcomes of the PINNACLE studies are the first from a series of pipeline candidates using Pearl's technology.
- PT003 was assessed in over 3,700 patients in over 275 study sites. The primary efficacy endpoint was trough forced expiratory volume in one second (FEV1). PT003 demonstrated statistically significant improvements in FEV1 versus placebo and the individual components glycopyrronium (PT001) and formoterol fumarate (PT005). PT001 and PT005 also showed statistically significant improvements in FEV1 compared to placebo.
- The company plans to file regulatory applications beginning this year. It will present the study results at a scientific meeting later this year.
- Related tickers: (NYSE:GSK) (NASDAQ:THRX) (NYSE:NVS) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY)
Mar. 16, 2015, 8:26 AM
- A Phase 3 study evaluating Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) in patients with hypercholesterolemia showed that patients receiving Praluent 150 mg every two weeks lowered their low-density lipoprotein cholesterol (LDL-C) by an additional 62% (p<0.0001) at Week 24 compared to placebo, with consistent LDL-C lowering maintained over 78 weeks (56% reduction, p<0.0001).
- The trial, call ODYSSEY LONG TERM, assessed Praluent 150 mg (n=1,553) compared to placebo (n=788) in patients judged at high cardiovascular (CV) risk and who were receiving the maximum tolerated dose of statin therapy with or without other lipid-lowering treatment. Patients self-administered a subcutaneous injection of Praluent every two weeks via a pre-filled syringe.
- At Week 24, 81% of patients in the Praluent cohort achieved their pre-specified LDL-C goal compared to 8.5% for placebo (p<0.0001).
- Praluent is an investigational human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Inhibiting PCSK9 frees up more LDL receptors on the surface of liver cells which enables the more LDL-C to be removed from the blood.
- Alirocumab and Amgen's (NASDAQ:AMGN) evolocumab are the front-runners to dominate the post-statin cholesterol-lowering market. They will be competing right out the blocks in the U.S. The FDA's PDUFA dates are July 24 alirocumab and August 27 for evolocumab. Praluent is being co-developed by Sanofi (NYSE:SNY).
Other News & PR