Regeneron - A Review: Strong Returns Look Likely For 2016 And Beyond
DoctoRx • 55 Comments
DoctoRx • 55 Comments
Regeneron Jumps Ahead In $10 Billion Race For Next Generation Cardio Drugs
Cheryl Swanson • 14 Comments
Cheryl Swanson • 14 Comments
Tue, Feb. 9, 9:19 AM
Tue, Feb. 9, 7:23 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) Q4 results ($M): Total Revenues: 1,098.1 (+36.9%); Net Product Sales: 749.5 (+43.7%); Sanofi Collaboration Revenue: 165.7 (+22.5%); Bayer Collaboration Revenue: 164.8 (+20.2%).
- EYLEA Sales: 746 (+44.0%); Praluent: 7, Sanofi Praluent Sales: 5(€).
- Net Income: 155.0 (+72.0%); EPS: 1.34 (+71.8%); Non-GAAP EPS: 2.83 (+1.8%).
- 2016 Guidance: Eylea Sales Growth: ~20%.
- Shares are off 5% premarket on light volume.
- SA Contributor DoctoRx provides an informative view on Regeneron's growth prospects with a recent article.
Tue, Feb. 9, 6:36 AM
Mon, Feb. 8, 5:30 PM
Mon, Feb. 1, 10:29 AM
- Thinly traded nano cap EyeGate Pharmaceuticals (EYEG +75.3%) jumps on a 14x surge in volume, albeit on turnover of only 460K shares, in apparent response to two bullish ratings by analysts.
- H.C. Wainwright initiated coverage with a Buy rating and $10 price target as did Rodman & Renshaw.
- The company is developing an ophthalmic solution (EGP-3437) for the treatment of macular edema that is administered via a non-invasive process called iontophoresis which represents a significant route-of-administration advantage over Regeneron's (REGN -1.6%) EYLEA (aflibercept) which is injected into the eye. Additional data from a Phase 1a/2b study are expected by mid-year.
- Previously: Eyegate Pharma announces positive results for EGP-437; shares jump 68% (Nov. 5, 2015)
Fri, Jan. 29, 12:03 PM
- Medifast (MED +1.4%) initiated with Hold rating and $32 (10% upside) price target by Wunderlich.
- Kite Pharma (KITE +4.1%) initiated with Buy rating and $70 (51% upside) price target by SunTrust Robinson Humphrey.
- STAAR Surgical (STAA +0.3%) initiated with Hold rating by Benchmark.
- Nektar Therapeutics (NKTR -2.4%) initiated with Buy rating and $21 (57% upside) price target by Janney Capital.
- BioBlast Pharma (ORPN +7.7%) initiated with Buy rating and $25 (574% upside) price target by H.C. Wainwright.
- CVS Health (CVS +1.3%) initiated with Outperform rating and $108 (14% upside) price target by Baird.
- Walgreens Boots Alliance (WBA +1.1%) initiated with Outperform rating and $96 (22% upside) price target by Baird.
- Intercept Pharma (ICPT +0.6%) upgraded to Equal Weight from Underweight by Morgan Stanley. Price target is $100 (0% upside).
- Stryker (SYK +1.8%) upgraded to Buy from Hold by Brean Capital. Price target is $115 (16% upside).
- Voyager Therapeutics (VYGR -0.7%) upgraded to Neutral from Sell by Chardan Capital. Price target lowered to $15 (50% upside) from $20.
- Bristol-Myers Squibb (BMY +1.9%) upgraded to Buy from Hold by Berenberg. Price target raised to $77 (24% upside) from $74.
- Oncomed Pharmaceuticals (OMED -0.3%) downgraded to Market Perform from Outperform by Leerink. Price target lowered to $11 (23% upside) from $27.
- Regeneron Pharmaceuticals (REGN +0.6%) downgraded to Sell from Neutral by Chardan Capital. Price target lowered to $400 (4% downside risk) from $525.
Fri, Jan. 22, 8:23 AM
- Credit Suisse analysts have been very busy lately with a long list of initiations: Acceleron Pharma (NASDAQ:XLRN) Outperform with $50 (47% upside) price target; BioMarin Pharmaceutical (NASDAQ:BMRN) Outperform with $110 (36% upside) price target; Amgen (NASDAQ:AMGN) Outperform with $205 (34% upside) price target.
- Celgene (NASDAQ:CELG) Outperform with $149 (41% upside) price target; Coherus Biosciences (NASDAQ:CHRS) Outperform with $25 (79% upside) price target; Gilead Sciences (NASDAQ:GILD) Outperform with $125 (40% upside) price target.
- Regeneron Pharmaceuticals (NASDAQ:REGN) Neutral with $552 (19% upside) price target; Vertex Pharmaceuticals (NASDAQ:VRTX) Outperform with $151 (59% upside) price target; Alnylam Pharmaceuticals (NASDAQ:ALNY) Outperform with $154 (117% upside) price target.
- Alexion Pharmaceuticals (NASDAQ:ALXN) Neutral rating with $201 (29% upside) price target; Biogen (NASDAQ:BIIB) Neutral with $322 (23% upside) price target; XenoPort (NASDAQ:XNPT) Underperform with $4 (16% downside risk) price target.
- PTC Therapeutics (NASDAQ:PTCT) Outperform with $36 (33% upside) price target; Mesoblast Limited (NASDAQ:MESO) Outperform with $10 (92% upside) price target and Incyte (NASDAQ:INCY) Outperform with $110 (49% upside) price target.
Fri, Jan. 22, 7:22 AM
- The Japanese Ministry of Health, Labour and Welfare approves Amgen's (NASDAQ:AMGN) Repatha (evolocumab) for the treatment of patients with familial hypercholesterolemia or hypercholesterolemia who have a high risk of cardiovascular events and do not adequately respond to statins.
- Repatha was developed in Japan by Amgen Astellas BioPharma K.K., a joint venture between Amgen and Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY). The marketing application was filed in March 2015. It is the first PCSK9 inhibitor approved there.
- Regeneron (NASDAQ:REGN) and Sanofi (NYSE:SNY) are playing catch up with Praluent (alirocumab). They reported successful Phase 3 data in July.
Fri, Jan. 8, 7:53 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and development partner Sanofi (NYSE:SNY) announce that the FDA has accepted for review the Biologics License Application (BLA) for sarilumab for the treatment of patients with moderate-to-severe rheumatoid arthritis (RA). The agency's action date (PDUFA) is October 30.
- Sarilumab is a human monoclonal antibody that inhibits the pro-inflammatory cytokine interleukin 6 (IL-6). By blocking the binding of IL-6 to its receptor, it interrupts the resultant cytokine-mediated inflammatory signalling.
- Previously: Sanofi and Regeneron's sarilumab successful in late-stage arthritis study (Nov. 9, 2015)
Dec. 11, 2015, 7:48 AM
- Sanofi (NYSE:SNY) and Regeneron (NASDAQ:REGN) edge out Amgen (NASDAQ:AMGN) for preferred access status for their PCSK9 inhibitor Praluent (alirocumab) in UnitedHealth Group's (NYSE:UNH) OptumRx and UnitedHealthcare for Commercial, Medicare and Managed Medicaid patients. Praluent is now on formularies covering more than 100M patients in the U.S., including Express Scripts and Aetna.
- Amgen's Repatha (evolocumab) is the preferred offering in CVS Health and the exclusive PCSK9 inhibitor for members of Harvard Pilgrim Health System. Express Scripts offers it as well. Patients covered in UnitedHealth's Oxford unit can transition to Repatha if a 12-week regimen of Praluent fails to do the job.
- Previously: Repatha and Praluent go toe-to-toe in PBMs (Dec. 1)
Dec. 1, 2015, 12:53 PM
- In a shining example of the beauty of competition, Amgen (AMGN +0.5%) is battling fiercely with Sanofi (SNY) and Regeneron (REGN -0.4%) for favored status of its cholesterol fighter Repatha (evolocumab) versus Praluent (alirocumab) in the leading pharmacy benefit managers (PBMs).
- Amgen won preferred listing in CVS Health (CVS +1.4%) and an exclusive deal with Harvard Pilgrim Health System. Express Scripts (ESRX +1.2%) covers both PCSK9 inhibitors while UnitedHealth's (UNH +2.5%) Oxford unit is taking a different approach. Plan members will have to try Praluent first. If it fails to do the job after 12 weeks, then they can try Repatha.
- UnitedHealth and its OptumRx PBM are largest unsigned accounts and are, no doubt, getting substantial exposure to the companies' representatives.
Nov. 24, 2015, 7:38 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) announce the completed enrollment of ~18,000 patients in their global Phase 3 study, ODYSSEY OUTCOMES, evaluating the potential cardiovascular (CV) benefits of cholesterol fighter Praluent (alirocumab) after an acute coronary syndrome (ACS). The trial is designed to determine if the addition of Praluent to intensive statin therapy reduces major adverse cardiac events in patients who have had an ACS (e.g., heart attack or unstable angina). The primary endpoint is time to first occurrence of coronary heart disease death, acute myocardial infarction (heart attack), hospitalization for unstable angina or fatal or non-fatal ischemic stroke. The study should be completed in 2017.
- The global ODYSSEY program includes 16 Phase 3 trials conducted across more than 2,000 medical centers around the world. More than 25,000 patients will be evaluated.
Nov. 23, 2015, 9:18 AM
- Round one in the Repatha (evolocumab) versus Praluent (alirocumab) competition goes to Amgen (NASDAQ:AMGN). After evaluating both PCSK9 inhibitors, Pharmacy benefit manager CVS Health (NYSE:CVS) exclusively adds Amgen's Repatha to its commercial formularies, effectively shutting out Sanofi (NYSE:SNY) and Regeneron's (NASDAQ:REGN) Praluent.
- No word yet on the decisions from other PBMs.
Nov. 18, 2015, 1:14 PM
- Britain's National Institute for Health and Care Excellence (NICE), which advises the National Health Service (NHS) on costs, procedures and technologies with the aim of better managing the cost/benefit of services, issues draft guidance not recommending Amgen's (AMGN +0.7%) Repatha (evolocumab) for the treatment of high cholesterol and mixed dyslipidemia.
- The committee determined that Repatha was effective in lowering LDL cholesterol ("bad" cholesterol) in patients with primary hypercholesterolemia, but cited the lack of evidence that it reduces the risk of cardiovascular disease-related events such as heart attacks, strokes and angina, which claim 150K English lives each year. It also doubted the reliability of the company's cost-effectiveness data, citing the use of the Framingham risk equations, which overestimate CVD risk in the UK population, and an unrealistically high factor to adjust the CVD risk in people with heterozygous-familial hypercholesterolemia.
- "The Committee concluded that the degree of uncertainty in the cost-effectiveness evidence was too high for it to be able to make well-founded recommendations about evolocumab." The public has until December 8 to comment on the draft guidance, which will be reviewed and discussed at the next NICE meeting on January 13.
- Sharpen that pencil, Amgen.
- Related tickers: (SNY +1.6%)(REGN +1.7%)
Nov. 11, 2015, 1:00 PM
- Alnylam Pharmaceuticals (ALNY +1.1%) and development partner The Medicines Company (MDCO -0.8%) announce positive results from their ongoing Phase 1 clinical trial evaluating ALN-PCSsc for the potential treatment of high cholesterol. The data were presented at the American Heart Association Scientific Sessions in Orlando, FL.
- As previously reported, subcutaneous administration of ALN-PCSsc reduced LDL-C (bad cholesterol) up to 83% (average maximum: 59 - 69%). New data showed the effects were highly durable and could support a twice/year dosing regimen, significantly longer than Amgen's (AMGN +0.6%) Repatha (evolocumab), dosed every two weeks or once/month, and Sanofi (SNY +0.3%)/Regeneron's (REGN +1%) Praluent (alirocumab), dosed every two weeks.
- Specifically, the maximum PCSK9 knockdown was 89% (average 80.3 - 84.3%) and the maximum LDL-C reduction was up to 78% (average 54.3 - 64.3%) after a single injection of ALN-PCSsc. At day 180, LDL-C reduction was as high as 53% (average 47%) in the 300 mg cohort. No clinically significant drug-related adverse events were seen.
- In the multiple dose cohorts (n=45), the maximum PCSK9 knockdown and LDL-C reduction were 94% (av. 86.9 - 90.1%) and 83% (av. 59.0 - 69.8%), respectively. At day 208, the LDL-C reduction was as high as 60% (av. 44.4%). In clinical trials, the mean LDL-C reductions observed for Repatha and Praluent were 64% (week 12) and 58% (week 24), respectively.
- Both Repatha and Praluent bind to PCSK9 in the blood. ALN-PCSsc turns off PCSK9 synthesis in the liver.
- The Medicines Company plans to initiate a Phase 2 study by year end with a Phase 3 trial to follow in 2017.
- The companies will host a conference call this afternoon at 4:30 pm ET to discuss the data.
Nov. 11, 2015, 7:52 AM
- A post-hoc analysis of six Phase 3 clinical trials showed that 74% of patients receiving Sanofi (NYSE:SNY) and Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) (75 mg) were able to reach their pre-specified LDL cholesterol (LDL-C) targets within eight weeks of adding the drug to their standard-of-care treatment, including statins. In the 26% of patients whose Praluent dose was increased to 150 mg, most (61%) were able to achieve their LDL-C target, with an average additional reduction in LDL-C of 14%. The data were presented at the American Heart Association Scientific Sessions in Orlando, FL.
- The results are based on a pooled post-hoc analysis of 1,291 patients with high cardiovascular (CV) risk or an inherited form of high cholesterol called heterozygous familial hypercholesterolemia (HeFH).
- The incidence of adverse events was comparable for the two doses in the placebo-controlled studies (66%) and in the ezetimibe (Merck's Zetia)-controlled studies (55% vs. 56%).
- In a separate pooled post-hoc analysis of 3,499 patients, subjects with diabetes (n=1,051) who initially received Praluent (75 mg or 150 mg every two weeks) experienced mean percent reductions in LDL-C of 44% and 58%, respectively, compared to placebo at week 24 (p<0.0001).
- A third post-hoc analysis of 4,974 patients did not find an increased risk of diabetes-related adverse events among those who did not have diabetes when they entered the trials, regardless of whether they were receiving Praluent or were in a control group. There was no evidence that Praluent affected the incidence of new-onset diabetes or pre-diabetes.
- Praluent, a PCSK9 inhibitor, was cleared by the FDA in July 2015.
Regeneron Pharmaceuticals, Inc. operates as a biopharmaceutical company. It discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer and a rare inflammatory condition... More
Country: United States
Other News & PR