Regeneron Pharmaceuticals, Inc.NASDAQ
Regeneron - A Review: Strong Returns Look Likely For 2016 And Beyond
DoctoRx • 55 Comments
DoctoRx • 55 Comments
Mon, Oct. 17, 8:07 AM
- The FDA has placed a clinical hold on a Phase 2b clinical trial assessing Regeneron Pharmaceuticals (NASDAQ:REGN) and Teva Pharmaceutical Industries' (NASDAQ:TEVA) fasinumab for the treatment of chronic low back pain. The agency has also requested an amendment to the study protocol after observing a case of confirmed arthropathy (joint disease) in a patient with advanced osteoarthritis who was receiving high dose fasinumab. Regeneron has stopped dosing in the study after completing an unplanned interim review of the data which showed clear evidence of efficacy over placebo at the eight- and 12-week time points. Patients will continue to be followed for up to 36 weeks.
- There are three fasinumab dose cohorts in the study: 6 mg and 9 mg subcutaneously once/month and 9 mg intravenously every two months. Enrollment was 70% completed (target: 800). Updated results will be presented at an upcoming medical conference.
- Based upon the data, the companies intend to design a Phase 3 trial in chronic low back pain that excludes patients with advanced osteoarthritis.
- Results from a previously reported Phase 2/3 study in osteoarthritis pain, a potential dose-dependent rate of arthropathy was observed. Consequently, only the lower doses will be advanced in Phase 3 studies.
- Fasinumab is a fully human monoclonal antibody that targets Nerve Growth Factor, a protein that plays a key role in the regulation of pain signaling.
- Regeneron and Teva are co-developing and co-commercializing fasinumab under an agreement inked last month.
- Regeneron is down 1% premarket on light volume. Teva is up a fraction.
- Previously: Regeneron's fasinumab successful in mid-stage study in treatment-resistant arthritis (May 2)
Thu, Oct. 13, 8:41 AM
- Micro cap Ocular Therapeutix (NASDAQ:OCUL) is up 28% premarket on robust volume in response to its announcement of a strategic collaboration with Regeneron Pharmaceuticals (NASDAQ:REGN) to develop a sustained-release formulation of aflibercept, marketed in the U.S. under the brand name EYLEA, for the treatment of wet age-related macular degeneration (wet AMD) and other retinal disorders.
- Under the terms of the agreement, Regeneron has the option to secure an exclusive license to Ocular's hydrogel-based technology for a sustained-release formulation of aflibercept and other biologics targeting VEGF for ophthalmic indications. Ocular retains the rights to its platform for all other non-VEGF-targeting compounds in addition to small molecule drugs for other retinal diseases. If Regeneron exercises its option, Ocular will receive a $10M payment and will be responsible for Phase 1 development. Regeneron will be responsible for further development and commercialization. Ocular will be eligible to receive up to $305M in milestones and tiered royalties on net sales from high-single-digit to low-to-mid-teens.
Fri, Sep. 30, 9:08 AM
- Ophthotech (NASDAQ:OPHT) slumps 13% premarket on robust volume in apparent response to Regeneron Pharmaceuticals' (NASDAQ:REGN) unsuccessful Phase 2 study of a co-formulated therapy of EYLEA (aflibercept) and rinucumab, an anti-platelet-derived growth factor receptor beta monoclonal antibody (anti-PDGFR-beta), for the treatment of wet AMD. The combo therapy failed to show a treatment benefit over EYLEA alone.
- Ophthotech is also investigating a combination therapy for wet AMD: Fovista, targeting platelet-derived growth factor (PDGF), administered with Roche's (OTCQX:RHHBY) Lucentis (ranibizumab), an anti-VEGF therapy. Unlike Regeneron, though, results from a Phase 2b study showed statistical superiority of the combo compared to Lucentis alone. Phase 3 development is underway.
- Previously: Regeneron's Eylea combo no better than Eylea alone in mid-stage study in wet AMD (Sept. 30)
Fri, Sep. 30, 8:26 AM
- Sanofi (SNY) and Regeneron (REGN) will host a conference call for the financial community on on Saturday, October 1 at 7:00 am ET to discuss the results from two clinical trials, SOLO 1 and SOLO 2, assessing dupilumab for the treatment of inadequately controlled moderate-to-severe atopic dermatitis.
- Results from the studies will be presented at the 25th European Academy of Dermatology and Venereology Congress in Vienna, Austria.
Fri, Sep. 30, 7:44 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) says a Phase 2 clinical trial, CAPELLA, evaluating EYLEA (aflibercept) co-formulated with rinucumab, for the treatment of patients with neovascular age-related macular degeneration (wet AMD) failed to demonstrate a treatment benefit over EYLEA alone. Specifically, the combination did not show an improvement in best corrected visual acuity (BCVA) at Week 12, the primary endpoint. Both groups treated with the combination showed a 5.8 letter improvement in BCVA, short of the 7.5 letter improvement in those receiving EYLEA alone.
- CAPELLA is an ongoing double-masked, controlled, multiple-dose, regimen ranging study involving ~500 wet AMD patients. Subjects were randomized to receive fixed doses every four weeks of either EYLEA 2 mg, EYLEA 2mg/rinucumab 1 mg or EYLEA 2 mg/rinucumab 3 mg. The co-formulation was administered as a single intravitreal injection. At Week 12, two of the three treatment groups were re-randomized which increased the total dosing groups to five in the second phase of the study. Data readouts are planned at 28 and 52 weeks, the end of the trial. According to ClinicalTrials.gov, the estimated study completion date is June 2017.
- Rinucumab is a monoclonal anti-platelet-derived growth factor receptor beta (anti-PDGFR-beta) antibody being co-developed by Regeneron and Bayer (OTCPK:BAYRY) under a March 2016 agreement.
- More detailed results will be presented at a future medical conference.
- Previously: Regeneron and Bayer to develop combo therapy for eye diseases (March 24)
Mon, Sep. 26, 6:58 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and co-developer Sanofi (NYSE:SNY) announce that the FDA has accepted for review the Biologics License Application (BLA) seeking approval of dupilumab for the treatment of inadequately controlled moderate-to-severe atopic dermatitis (AD), a Breakthrough Therapy-tagged use. If approved, it will be the first systemic therapy for the condition.
- The FDA's action date (PDUFA) is March 29, 2017.
- 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 companies will host an Investor Relations Conference Call to following the late breaking data presentation from two late-stage studies, LIBERTY AD SOLO 1 and SOLO 2, that supported the filing on Saturday, October 1 at 7:00 am ET at the 25th European Academy of Dermatology and Venereology Congress in Vienna, Austria.
Tue, Sep. 20, 7:40 AM
- Teva Pharmaceutical Industries (NASDAQ:TEVA) and Regeneron Pharmaceuticals (NASDAQ:REGN) enter into a global agreement to develop and commercialize Regeneron's fasinumab, currently in Phase 3 for osteoarthritis pain and Phase 2 for chronic lower back pain.
- Under the terms of the deal, Regeneron will receive an upfront payment of $250M plus milestones and will equally share the global commercial value as well as the ~$1B R&D costs. It will lead global development and U.S. commercialization while splitting the U.S. profits 50/50. Outside of the U.S., exclusive of the territory (11 countries in Asia) covered in a previous collaboration between Regeneron and Mitsubishi, Teva will be responsible for development and commercialization and will pay Regeneron a specific purchase price for the product.
- Fasinumab is a fully human monoclonal antibody that targets Nerve Growth Factor (NGF), a protein that plays a key role in the regulation of pain signaling.
Tue, Aug. 30, 5:34 PM
- A Phase 2 proof-of-concept, double-blind, placebo-controlled randomized study, MILANO-PILOT, assessing The Medicines Company's (NASDAQ:MDCO) MDCO-216 for reducing atherosclerotic plaque burden failed to achieve the efficacy results necessary for an early end to the trial. In a report, the Independent Data Monitoring Committee recommended the study continue citing the inconclusiveness of the interim data from 40 subjects. Results from the full group of 120 patients will be presented at the American Heart Association Scientific Sessions in mid-November.
- MDCO-216 a complex of a recombinant protein, apolipoprotein A-1 Milano, and phospholipid (POPC). It mimics pre-beta high density lipoprotein (HDL) and induces cholesterol efflux (flowing out), the first step in the removal of deposited cholesterol from the walls of blood vessels (reverse cholesterol transport). The company wants to prove that it improves cardiovascular outcomes.
- Also on tap for the AHA in November is interim data from the Phase 2 ORION-1 study assessing PCSK9si in 501 patients with atherosclerotic cardiovascular disease and elevated LDL-C despite maximum tolerated doses of LDL-C-lowering drugs. The study is comparing the effects of different doses of PCSK9si as well as evaluating the potential for quarterly or bi-annual dosing. The primary endpoint is the percent change in LDL-C from baseline at Day 180.
- PCSK9si, a GalNAc-conjugated RNAi therapeutic that targets PCSK9, is under development for the treatment of high cholesterol (hypercholesterolemia). PCSK9si turns off PCSK9 synthesis in the liver which is different that anti-PCSK9 monoclonal antibodies [Amgen's (NASDAQ:AMGN) Repatha (evolocumab) and Sanofi (NYSE:SNY)/Regeneron's (NASDAQ:REGN) Praluent (alirocumab)] which bind to PCSK9 in the blood.
- MDCO is down 8% after hours on light volume.
Mon, Aug. 29, 8:34 AM
- A 62-subject Phase 3 clinical trial, ODYSSEY ESCAPE, assessing Sanofi (NYSE:SNY) and Regeneron Pharmaceuticals' (NASDAQ:REGN) PCSK9 inhibitor Praluent (alirocumab) in patients with heterozygous familial hypercholesterolemia (HeFH) who require weekly/bi-weekly apheresis treatment, showed adding Praluent to existing therapy lowered LDL cholesterol (LDL-C) by ~50% from baseline versus a 2% increase for placebo. In addition, treatment with Praluent reduced the need for apheresis treatment by 75% compared to placebo (p<0.0001), the primary endpoint. The results are being presented today at the European Society of Cardiology Congress in Rome.
- Apheresis is a procedure similar to kidney dialysis that is used to remove LDL-C from the blood in high-risk patients who fail to respond adequately to cholesterol-lowering therapies. The cost can be up to $100K a year and can include a substantial travel burden for Americans since there are only ~60 apheresis centers in the U.S.
- In the study, 93% of the participants reduced their apheresis procedures at least 50%.
Mon, Aug. 22, 9:49 AM
- Amgen (AMGN +0.3%) certainly gets a "A" for effort for its commitment to disappointing cholesterol med Repatha (evolocumab). It has 11 abstracts for presentation at the upcoming European Society of Cardiology Congress 2016 in Rome, August 27 - 31. In addition, it has six ongoing clinical trials that will support expanded labeling.
- Evolocumab is a 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. It, along with Regeneron Pharmaceuticals (REGN +2.3%) and Sanofi's (SNY -0.7%) Praluent (alirocumab), were expected to replace statins and take over the global cholesterol-lowering market. Sales have lagged, however, due in part to their high prices. Last quarter, Amgen reported only $27M in Repatha sales, slightly ahead of Praluent's $24M.
- The FDA approved both drugs about a year ago.
Mon, Aug. 22, 9:04 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) enters into an agreement with the U.S. Department of Health and Human Services' (HHS) Biomedical Advanced Research and Development Authority (BARDA) to manufacture and study two antibodies for the potential prevention and treatment of Middle East Respiratory Syndrome (MERS). There are currently no approved therapies or vaccines to prevent/treat MERS, an upper respiratory tract infection associated with a high death rate.
- Under the terms of the agreement, HHS will provide up to $8.9M to support packaging and labeling of the antibodies for human use, the preparation and submission of an Investigational New Drug (IND) application with the FDA and a Phase 1 study in healthy volunteers to be conducted by the National Institutes of Health.
- The MERS candidates were discovered and developed under the company's antibody discovery and preclinical development partnership with Sanofi (NYSE:SNY), who has opt-in rights for development and commercialization.
- Regeneron and BARDA have an existing agreement to advance an Ebola candidate that was discovered and developed at Regeneron. The Orphan Drug-tagged potential therapeutic recently entered a Phase 1 study.
Fri, Aug. 12, 8:04 AM
- TeamHealth Holdings (NYSE:TMH) upgraded to Buy from Hold with a $52 (41% upside) price target by Jefferies.
- Editas Medicine (NASDAQ:EDIT) upgraded to Buy from Hold with a $35 (69% upside) price target by Jefferies.
- ZIOPHARM Oncology (NASDAQ:ZIOP) upgraded to Market Perform from Underperform by Wells Fargo. Target price range: $5 - 8 (25% upside from midpoint).
- Bellicum Pharmaceuticals (NASDAQ:BLCM) upgraded to Buy from Neutral with a $24 (22% upside) price target by Citigroup.
- Alere (NYSE:ALR) upgraded to Buy from Neutral with a $48 (20% upside) price target by BTIG Research.
- Merck (NYSE:MRK) upgraded to Outperform from Neutral by Credit Suisse. Price target raised to $73 (15% upside) from $62. Upgraded to Outperform from Market Perform by BMO Capital. Price target raised to $72 (13% upside) from $62.
- Celgene (NASDAQ:CELG) upgraded to Buy from Neutral with a $138 (21% upside) price target by BTIG Research.
- Bristol-Myers Squibb (NYSE:BMY) downgraded to Hold from Buy by Berenberg. Price target lowered to $70 (15% upside) from $80. Downgraded to Neutral from Outperform by Credit Suisse. Price target lowered to $63 (3% upside) from $86.
- Zosano Pharma (NASDAQ:ZSAN) downgraded to Neutral from Buy by Ladenburg Thalmann.
- Myriad Genetics (NASDAQ:MYGN) downgraded to Hold from Buy by Gabelli & Co. Price target lowered to $32 (54% upside) from $46.
- Ohr Pharmaceutical (NASDAQ:OHRP) downgraded to Hold from Buy by Brean Capital.
- Inovio Pharmaceuticals (NASDAQ:INO) downgraded to Hold from Buy by Maxim Group. $14 price target removed.
- Raptor Pharmaceutical (NASDAQ:RPTP) downgraded to Neutral from Buy by Citigroup. Price target raised to $8 (19% upside) from $6.
- Regeneron Pharmaceuticals (NASDAQ:REGN) downgraded to Neutral from Outperform by Baird. Price target lowered to $488 (16% upside) from $505.
Thu, Aug. 4, 10:12 AM
- Regeneron Pharmaceuticals (REGN -4.4%) Q2 results: Revenues: $1,212.6M (+21.4%); R&D Expense: $559.9M (+43.5%); SG&A: $292M (+67.2%); Operating Income: $291.6M (-15.5%); Net Income: $196.2M (+0.8%); EPS: $1.69 (unch); Non-GAAP EPS: $2.82 (+24.2%); Quick Assets: $1,635M (-2.5%).
- 2016 Guidance: EYLEA U.S. Sales Growth: 20 - 25%; Sanofi reimbursement of commercialization-related expenses: $310M - 340M from $320M - 370M.
Thu, Aug. 4, 6:32 AM
Wed, Aug. 3, 5:30 PM
- AAC, AAON, ACRE, ACTA, AGCO, AGIO, AKRX, ALSK, AMCX, AME, AMRN, ANIP, ANSS, APA, APLP, ARRY, AYR, BBW, BCE, BCRX, BDX, BLL, CBB, CCOI, CHD, CHK, CNNX, CNSL, COT, CPK, CRIS, CRZO, CTB, DNR, DUK, DW, ELOS, EPAM, ESNT, EVA, FMSA, GLDD, GLOG, GOGO, GTN, HAR, HGG, HII, HL, HMHC, HRC, HSC, HSIC, HSNI, ICPT, IMGN, IOC, IPCC, IRM, IT, ITCI, ITT, K, KOP, LBY, LFUS, LGND, LIOX, LPX, LQDT, LXRX, MFC, MGM, MGP, MITL, MMS, MNTA, MPEL, MPG, MPW, NAO, NERV, NGS, NOK, NSAM, NXTM, OGE, OMAM, OMF, ORBC, PBH, PCRX, PGNX, PGTI, PH, PLUG, PPP, PRFT, PRIM, PRTY, PWR, QSR, RDUS, REGN, RFP, RGEN, RLGY, ROLL, RVLT, RWLK, SBH, SEAS, SFM, SGM, SHLX, SNR, SPAR, SPH, SRE, SSTK, SSYS, STFC, STOR, STWD, TDY, TEVA, THS, TICC, TIME, TK, TNK, TOO, TSEM, TVPT, TWI, UAM, UNT, USAC, USCR, VIAB, VLP, VWR, WIN, WPC, WRK, XLRN
Mon, Jul. 11, 9:40 AM
- The FDA approves a new monthly dosing option for Amgen's (AMGN +0.2%) cholesterol fighter Repatha (evolocumab), the first for a PCSK9 inhibitor. Patients can now self-administer a single subcutaneous dose of 420 mg of evolocumab using the hands-free Pushtronex device (on-body infusor with prefilled cartridge). The original dosing regimen, which remains in place, is 140 mg every two weeks.
- Regeneron Pharmaceuticals (REGN +0.7%) and Sanofi's (SNY +1%) Praluent (alirocumab) is dosed every two weeks up to a maximum of 150 mg per dose.
- Evolocumab is a 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.