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, Apr. 5, 10:46 AM
- Geoffrey Porges of Leerink maintained an Outperform rating on Regeneron (NASDAQ:REGN) and raised his price target from $505 to $523, marking 30% upside from current levels.
- The analyst is bullish on the future of two drugs: Dupilumab, in Phase 3 testing to treat atopic dermatitis, is demonstrating impressive results that exceed Porges’ expectations in terms of efficacy and safety. He believes the drug will succeed in commercialization and raises his forecasts for the Dupilumab revenue by 18% in 2017-2020.
- Eylea, the company’s approved injection for multiple retinal diseases, continues to grow commercially. Porges expects the drug to garner $5B in sales by 2016, and then continue growing through 2020.
- According to TipRanks, Porges has a 65% success rate recommending stocks with a +2.8% average one-year return per rating.
- Now read Regeneron Is My Top Pick In The Biotech Space »
Fri, Apr. 1, 9:35 AM
- A Phase 3 clinical trial, SPIRE-AI, assessing Pfizer's (PFE -0.2%) bad cholesterol fighter, bococizumab, in patients with hyperlipidemia or mixed dyslipidemia on statin therapy and whose LDL-C (low density lipoprotein cholesterol) was at least 70 mg/dL (less than 100 mg/dL is optimal) met its co-primary endpoints of a statistically valid percent change from baseline in LDL-C and the proportion of patients successfully operating the pre-filled pen.
- SPIRE-AI is the second of six SPIRE Phase 3s that will support the company's regulatory applications. The 299-subject, randomized, double-blind, placebo-controlled, parallel-group study evaluated the safety, tolerability and efficacy of subcutaneous administration of 75 mg and 150 mg of bococizumab via a pre-filled pen.
- Bococizumab is a PCSK9 inhibitor under development for lowering LDL-C and improving cardiovascular outcomes in a broad range of high-risk patients.
- There are two PCSK9 inhibitors currently available in the U.S.: Amgen's (NASDAQ:AMGN) Repatha (evolocumab) and Praluent (alirocumab), co-developed by Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY).
- Complete results will be presented at a future medical conference.
- According to clinicaltrials.gov, Pfizer's SPIRE-1 study of bococizumab in reducing cardiovascular events will run until April 2018. SPIRE-LL and SPIRE-LDL should be completed by July of this year. SPIRE-HR should wind up this month.
- Now read Pfizer: 30%+ Discount with 4% Yield
Fri, Apr. 1, 7:44 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and co-developer Sanofi (NYSE:SNY) announce successful results from two Phase 3 clinical trials evaluating dupilumab in adult patients with inadequately controlled moderate-to-severe atopic dermatitis (AD).
- Both studies, LIBERTY AD SOLO 1 and SOLO 2, met their primary endpoints and demonstrated significant improvements in measures of overall disease severity, skin clearing, itching, quality of life and mental health. These are the first Phase 3 trials of a systemic therapy that show this level of benefit in moderate-to-severe AD. There are no currently approved systemic therapies in the U.S. for the condition.
- There were 1,379 adults with moderate-to-severe AD enrolled in the two identical studies. They were randomized to receive 300 mg of dupilumab subcutaneously once per week, 300 mg every two weeks or placebo for 16 weeks following an initial dupilumab loading dose of 600 mg subcutaneously or placebo.
- For SOLO 1 and SOLO 2, 37% and 36% of patients, respectively, in the 300 mg once/week cohort and 38% and 36% of the 300 mg every two weeks cohort achieved clearing or near-clearing of skin lesions compared to 10% and 8.5% for placebo (p<0.0001). This was the primary endpoint.
- The improvements in another metric, EASI score, from baseline were 72% and 69%, 51% and 44% and 15% and 12%, respectively, for the three groups (p<0.0001).
- The proportions of patients achieving EASI-75 (75% improvement in AD symptoms) were 52.5% and 48%, 51% and 44% and 15% and 12%, respectively, for the three groups (p<0.0001). This was the key secondary endpoint in the U.S. and one of the primary endpoints in the EU.
- The overall rate of adverse events was 65 - 73% for dupilumab and 65 - 72% for placebo. The rate of serious adverse events was lower for dupilumab (1 - 3%) versus placebo (5 - 6%). Adverse events for dupilumab that were higher than placebo were injection site reactions (10-20% vs. 7-8%) and conjunctivitis (7-12% vs. 2%). No patient discontinued dupilumab therapy due to an injection site reaction. One discontinued due to conjunctivitis.
- Dupilumab, a fully human monoclonal antibody, works by binding to (inhibiting) interleukin-4 (IL-4) and interleukin-13 (IL-13), two cytokines that play key roles in the pathogenesis of AD. The FDA designated it a Breakthrough Therapy for AD in November 2014. A New Drug Application (NDA) should be submitted by Q3.
- More detailed results from the two studies will be presented at future medical conferences.
- Now read Regeneron - A Review: Strong Returns Look Likely for 2016 and Beyond
Thu, Mar. 24, 9:17 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and Bayer (OTCPK:BAYRY) will jointly develop a combination therapy of nesvacumab and aflibercept (EYLEA) for the treatment of serious eye diseases.
- Under the terms of the agreement, Regeneron will receive a $50M upfront payment and up to $80M in development and regulatory milestones. Bayer will have exclusive commercialization rights ex-U.S. and will equally share potential profits with Regeneron. In the U.S., Regeneron has exclusive commercialization rights and will retain 100% of the potential profits.
- Nesvacumab, developed by Regeneron, is a fully human monoclonal antibody that binds to a vascular growth factor called angiopoietin2 (Ang2). Aflibercept is a recombinant fusion protein that binds to vascular endothelial growth factor-A (VEGF). Angiopoietins, discovered by scientists at Regeneron, act with the VEGF family to promote the formation and maturation of blood lymphatic vessels in the eye. In certain eye diseases, the combined activity of Ang2 and VEGF contribute to the pathology of the disorders.
- Two separate Phase 2 studies assessing the combination are in process. The first, called ONYX, is targeted to neovascular age-related macular degeneration. The estimated study completion date is November 2017. The second, RUBY, is targeted to diabetic macular edema. It should be completed by October 2017. If successful, the development should proceed to Phase 3.
- Update: In a March 29 regulatory filing, Regeneron reports that Bayer will pay 25% of the global development costs and 50% of the development costs ex-U.S. The agreement also includes a standstill provision which prohibits Bayer HealthCare and its affiliates from seeking to influence the control of Regeneron or acquiring more than 20% of its common or Class A stock. The provision, which will expire on the fifth anniversary of the end of the contract, is substantially similar to the standstill provision in the companies' January 10, 2014 License and Collaboration Agreement.
Wed, Mar. 23, 7:04 AM
- Results from a Phase 3 clinical trial, ODYSSEY ESCAPE, evaluating Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi' s (NYSE:SNY) Praluent (alirocumab) Injection in patients with heterozygous familial hypercholesterolemia (HeFH) who require chronic apheresis therapy showed those who added Praluent to their existing treatment regimen reduced the frequency of their apheresis therapy by 75% compared to placebo (p<0.0001). In addition, 63% of patients receiving Praluent no longer required apheresis compared to zero for placebo. This is the first time a PCSK9 inhibitor has demonstrated that it can reduce the frequency of apheresis therapy.
- The study involved 62 HeFH patients in the U.S. and Germany. They were randomized to receive either 150 mg of Praluent subcutaneously every two weeks or placebo. During the first six weeks patients remained on their established apheresis schedule. The following 12 weeks the frequency of apheresis was adjusted based on their LDL-C response to treatment.
- Heterozygous familial hypercholesterolemia is an inherited form of high cholesterol that leads to early heart attacks in both men and women. Many required routine (1 - 2 times/week) apheresis therapy to remove LDL-cholesterol from their blood. Apheresis is a procedure in which the patient's blood is passed through an apparatus to remove a particular constituent. It is time-consuming (takes ~three hours) and expensive ($100k/year).
- Praluent was cleared in the U.S. in July 2015 and in the EU two months later.
- Related ticker: (NASDAQ:AMGN)
Fri, Mar. 18, 11:52 AM
- Insmed (INSM -0.7%) initiated with Buy rating and $23 (105% upside) price target by Stifel Nicolaus.
- Regeneron Pharmaceuticals (REGN +0.8%) initiated with Buy rating and $574 (57% upside) price target by Gabelli & Co.
- RegenRx Biopharmaceuticals (OTCQB:RGRX -7.9%) initiated with Buy rating and $2 (245% upside) price target by Rodman & Renshaw.
- Anacor Pharmaceuticals (ANAC -1.8%) initiated with Buy rating and $103 (84% upside) price target by Mizuho Securities.
- Acura Pharmaceuticals (ACUR) initiated with Buy rating and $6 (183% upside) price target by Roth Capital.
- NeoGenomics (NEO -0.2%) initiated with Buy and $8 (26% upside) price target by Benchmark.
- Depomed (DEPO -0.5%) initiated with Outperform rating and $21 (62% upside) price target by Leerink Swann.
- Galectin Therapeutics (GALT +1.6%) initiated with Buy and $6 (380% upside) price target by Roth Capital.
Thu, Mar. 17, 5:21 PM
- Thinly traded nano cap CymaBay Therapeutics (NASDAQ:CBAY) is down 16% after hours on robust volume in response to its announcement of results in a Phase 2 pilot study assessing Orphan Drug-tagged MBX-8025 in patients with homozygous familial hypercholesterolemia (HoFH), an inherited disorder characterized by abnormally high levels of bad LDL cholesterol (LDL-C) leading to premature cardiovascular disease.
- The 12-week, open-label, dose escalation trial enrolled 13 HoFH patients. All were receiving ezetimibe [Merck's (NYSE:MRK) Zetia] and were on maximum statin therapy. None were being treated with lomitapide [Aegion's (NASDAQ:AEGN) Juxtapid], mipomersen [Sanofi's (NYSE:SNY) Kynamro] or a PSCK9 inhibitor. The average baseline LDL-C level was 368 mg/dL (optimal level: less than 100 mg/dL). Subjects received 50 mg of MBX-8025 once daily for four weeks.
- Two per-protocol analyses were performed on 12 subjects (one was excluded due to missed apheresis visits). A responder analysis showed three patients experienced a reduction in LDL-C greater than 30%, five patients at least 20% and seven patients at least 15%. The average maximum decrease was 19%. A second analysis, averaging values across all doses and dosing periods, showed an overall average decrease in LDL-C of 10%, with eight subjects showing a mean decrease of 16% and three greater than 20%. Four patients showed a mean increase in LDL-C of 4%.
- Mean PCSK9 was elevated at baseline and increased significantly during treatment by an average of 43%, which was unexpected, and creates the need to assess the combination of MBX-8025 and a PCSK9 inhibitor [Amgen's (AMGN +0.1%) Repatha (evolocumab) or Regeneron (NASDAQ:REGN) and Sanofi's Praluent (alirocumab)] in a pilot study.
- 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.
- Previously: CymaBay product candidate an Orphan Drug for severe hypertriglyceridemia (April 22, 2015)
Wed, Mar. 16, 7:08 PM
- Chardan Capital's Gbola Amusa has downgraded Regeneron Pharma (NASDAQ:REGN) to Sell following Amgen's Repatha patent victory against Regeneron and Sanofi. His target has been cut by $50 to $325.
- Amusa: "We believe some in the market are diminishing the importance of today's verdict, taking the view that 1) an appeal could take years, 2) potential settlement royalties would still be around 5% based on the Roche (unrated) Eylea suit precedent, and 3) Praluent is not selling as well as we or others had expected."
- He also estimates a permanent injunction (if granted to Amgen at a March 23 hearing) "could lead to up to a $2bn/year EBIT transfer from Sanofi/REGN to AMGN," and sees "an increasing possibility that AMGN will not even consider a settlement."
- REGN -0.8% after hours to $365.50. Shares finished regular trading up 0.3%.
Wed, Mar. 16, 3:30 PM
- Amgen (AMGN +0.4%) chief Robert Bradway says, "We are thankful that the jury weighed the evidence carefully and recognized the validity of Amgen's patents on Repatha (evolocumab), our innovative biologic molecule that reduces LDL [bad] cholesterol."
- Earlier today, a jury in a Delaware federal court found the defendants Regeneron Pharmaceuticals (REGN +0.5%) and Sanofi (SNY -1.1%) failed to prove Amgen's patents, Nos. 8,829,165 and 8,859,741, invalid for lack of written description and enablement. In patent law, description and enablement means that, in order to to be considered for a patent, the product specification must clearly describe the manner and process of making and using the invention such that it enables another party skilled in the art to make and use it, which the jury believed Amgen had done.
- Prior to the case going to jury, the Court dismissed the defendants' case on obviousness, meaning there is no combination of "prior art" (previously patented products) that would bring the patentability of evolocumab into question.
- Prior to the trial, both Regeneron and Sanofi acknowledged infringing on seven patent claims of '165 and '741. They intend to appeal today's ruling.
Wed, Mar. 16, 11:52 AM
- Nasdaq has suspended trading in Regeneron Pharmaceuticals (REGN +2.6%) pending news. One possibility is a ruling on its patent fight with Amgen (AMGN -0.4%) over their PCSK9 inhibitors [Praluent (alirocumab) versus Repatha (evolocumab)].
- Here's an SA article by Markman Advisors for background.
- Update: Amgen patents upheld per report by Evercore ISI's Mark Schoenebaum. Permanent injunction hearing set for March 23 - 24. Regeneron to appeal. Judge ruled that Amgen failed to establish sufficient evidence of willful infringement (win for Regeneron).
- Update #2: Judge ruled that two Amgen patents covering antibodies targeting PCSK9 are valid. Regeneron and development/commercialization partner Sanofi (SNY -1.7%) intend to appeal the decision. The availability of Praluent is not affected at this time. Trading in REGN to resume at 1:00 pm ET. Initial trading has shares down only 1%.
Fri, Mar. 11, 10:12 AM
- Regeneron Pharma (REGN -0.3%) says its sarilumab rheumatoid arthritis drug met its primary endpoint as being superior to a competitor’s drug in improving signs and symptoms of the disease, according to a phase 3 study.
- REGN says the drug developed with Sanofi (SNY +1.4%) also met secondary endpoints in improving signs and symptoms in patients with active rheumatoid arthritis.
- Sarilumab was being compared with adalimumab, marketed by AbbVie (ABBV +1.1%) as Humira.
Wed, Mar. 9, 11:14 AM
- Number five on the list of top performers since the bear market's epic bottom seven years ago today is L Brands (NYSE:LB), which has returned 56% annually since. Coming in fourth is Under Armour (NYSE:UA), with a 59% annual return.
- In third place is Wyndham Worldwide (NYSE:WYN), with a 60% annual return, and in second is Regeneron (NASDAQ:REGN) which has gained 64% annually.
- The winner is previously left-for-dead General Growth Properties (NYSE:GGP), which was trading at $0.25 per share on March 9, 2009. At $28.30 today, the stock has returned 97% annually since (kudos Bill Ackman).
- Source: Barron's
Fri, Mar. 4, 9:00 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) initiated with Neutral rating and $450 (12% upside) price target by SunTrust Robinson Humphrey.
- GW Pharmaceuticals (NASDAQ:GWPH) initiated with Sell rating and implied price target of $30 (22% downside risk) price target by Numis Securities.
- Ardelyx (NASDAQ:ARDX) initiated with Buy rating and $15 (50% upside) price target by Citigroup.
- Seres Therapeutics (NASDAQ:MCRB) initiated with Buy rating and $41 (52% upside) price target by Guggenheim Securities.
- Seattle Genetics (NASDAQ:SGEN) initiated with Neutral rating and $34 (6% upside) price target by SunTrust Robinson Humphrey.
- Ligand Pharmaceuticals (NASDAQ:LGND) initiated with Buy rating and $146 (49% upside) price target by H.C. Wainwright.
- Agios Pharmaceuticals (NASDAQ:AGIO) initiated with Neutral rating and $43 (0% upside) price target by Janney Capital.
- Infinity Pharmaceuticals (NASDAQ:INFI) initiated with Outperform rating and $15 (127% upside) price target by FBR Capital.
- Trevena (NASDAQ:TRVN) initiated with Buy rating and $18 (104% upside) price target by WallachBeth.
- Bruker (NASDAQ:BRKR) initiated with Overweight rating and $30 (7% upside) price target by Barclays.
- Bluebird bio (NASDAQ:BLUE) initiated with Buy rating and $72 (33% upside) price target by BTIG Research.
- Aimmune Therapeutics (NASDAQ:AIMT) initiated with Outperform rating and $42 (135% upside) price target by Wedbush.
- Juniper Pharmaceuticals (NASDAQ:JNP) initiated with Buy rating and $18 (137% upside) price target by H.C. Wainwright.
- Celldex Therapeutics (NASDAQ:CLDX) initiated with Buy rating and $25 (203% upside) price target by H.C. Wainwright.
Fri, Feb. 26, 1:53 PM
- GlaxoSmithKline (GSK -0.9%) initiated with Hold rating and 1400p price target (-0.7% downside risk) by Cantor Fitzgerald.
- Shire plc (SHPG -0.6%) initiated with Buy rating by Cantor Fitzgerald.
- Insulet (PODD +8.7%) initiated with Sell rating and $15 (53% downside risk) price target by Empire Asset Management.
- MacroGenics (MGNX +2.2%) initiated with Equal Weight rating and $20 (29% upside) price target by Morgan Stanley.
- Biogen (BIIB +0.8%) initiated with Buy rating and $345 (30% upside) price target by Citigroup.
- Boston Scientific (BSX -0.3%) initiated with Buy rating and $21 (22% upside) price target by SunTrust Robinson Humphrey.
- Other initiations by Citigroup: Amgen (AMGN +1.1%) Neutral rating and $165 (11% upside) price target; Celgene (CELG +1.4%) Buy rating and $130 (25% upside) price target; Regeneron Pharmaceuticals (REGN) Buy rating and $480 (22% upside) price target; Alexion Pharmaceuticals (ALXN +0.1%) Neutral rating and $165 (18% upside) price target.
- IMS Health Holdings (IMS +0.2%) initiated with Outperform rating and $31 (19% upside) price target by Leerink Swann.
- Ocera Therapeutics (OCRX +5.7%) initiated with Buy rating and $10 (229% upside) price target by Brean Capital.
- Repligen (RGEN +3.8%) initiated with Buy rating and $36 (35% upside) price target by Craig-Hallum.
- Mesoblast (MESO -2.2%) initiated with Neutral rating and $5.50 (12% downside risk) price target by Chardan Capital.
- Ultragenyx Pharmaceutical (RARE +1.2%) initiated with Buy rating and $80 (29% upside) price target by Leerink Swann.
- Teva Pharmaceutical Industries (TEVA -0.2%) initiated with Outperform rating with $68-71 (21% upside from midpoint) price target by Wells Fargo.
- Medivation (MDVN +9.8%) initiated with Buy rating and $46 (28% upside) price target by Bank of America.
- Collegium Pharmaceutical (COLL -0.1%) initiated with Outperform rating and $35 (83% upside) price target by William Blair.
Fri, Feb. 19, 8:22 AM
- MacroGenics (NASDAQ:MGNX) initiated with Buy rating and $36 (110% upside) price target by Janney Capital.
- Alcobra (NASDAQ:ADHD) initiated with Buy rating with a $10 (95% upside) price target by Jefferies.
- Valeant Pharmaceuticals (NYSE:VRX) initiated with Buy rating and $150 (60% upside) price target by Rodman & Renshaw.
- Ocular Therapeutix (NASDAQ:OCUL) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target maintained at $15 (81% upside).
- HealthStream (NASDAQ:HSTM) upgraded to Buy from Hold with a price target of $25 (16% upside) by Needham.
- Juno Therapeutics (NASDAQ:JUNO) upgraded to Buy from Neutral by Guggenheim.
- Regeneron Pharmaceuticals (NASDAQ:REGN) upgraded to Neutral from Sell by Chardan Capital. Price target lowered to $375 (3% downside risk) from $400.
- Community Health Systems (NYSE:CYH) downgraded to Market Perform from Outperform by Avondale. Price target lowered to $18 (20% upside).
Fri, Feb. 12, 7:38 AM
- Gilead Sciences (NASDAQ:GILD) initiated with Outperform rating and $120 (37% upside) price target by Oppenheimer.
- CareDx (NASDAQ:CDNA) initiated with Buy rating and $12 (137% upside) price target by Janney Capital.
- Shire plc (NASDAQ:SHPG) initiated with Neutral rating by Guggenheim.
- Ultragenyx Pharmaceutical (NASDAQ:RARE) initiated with Buy rating and $104 (95% upside) price target by H.C. Wainwright.
- Depomed (NASDAQ:DEPO) initiated with Buy rating and $22 (38% upside) price target by UBS.
- ACADIA Pharmaceuticals (NASDAQ:ACAD) initiated with Buy rating and $40 (128% upside) price target by Bank of America.
- Leerink restarts coverage on eight stocks: four Outperforms: Alexion Pharmaceuticals (NASDAQ:ALXN); Regeneron Pharmaceuticals (NASDAQ:REGN); Vertex Pharmaceuticals (NASDAQ:VRTX) and Gilead Sciences (GILD); four Market Performs: Celgene (NASDAQ:CELG); Biogen (NASDAQ:BIIB); Medivation (NASDAQ:MDVN) and Amgen (NASDAQ:AMGN).
- TESARO (NASDAQ:TSRO) initiated with Buy rating by Lake Street.
- AbbVie (NYSE:ABBV) initiated with Outperform rating by William Blair.
- Seattle Genetics (NASDAQ:SGEN) upgraded to Buy with $38 (41% upside) price target by Cantor Fitzgerald.
- Shire plc (SHPG) upgraded to Outperform with price target of $240 (59% upside) by RBC.
- Amedisys (NASDAQ:AMED) upgraded to Outperform with $40 (15% upside) price target by Oppenheimer.
- Smith & Nephew (NYSE:SNN) downgraded to Neutral from Buy by UBS. Price target lowered to 1,100p (4% upside) from 1,250p.
- Quidel (NASDAQ:QDEL) downgraded to Hold from Buy by Canaccord. Price target lowered to $18 (18% upside) from $22.
- BioCryst Pharmaceuticals (NASDAQ:BCRX) downgraded Neutral from Overweight by JP Morgan. Price target lowered to $5 (201% upside) from $16.
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
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