Regeneron - A Review: Strong Returns Look Likely For 2016 And Beyond
DoctoRx • 55 Comments
DoctoRx • 55 Comments
Regeneron Jumps Ahead In $10 Billion Race For Next Generation Cardio Drugs
Cheryl Swanson • 14 Comments
Cheryl Swanson • 14 Comments
Tue, Jul. 5, 11:16 AM
- Thinly traded micro cap pSivida (PSDV +5.4%) bucks the market's bearishness. Shares are up on average volume (only ~23K shares so far) in response to its announcement of positive results from preclinical animal studies assessing the effectiveness of a sustained-release insert based on its Durasert technology to deliver a tyrosine kinase inhibitor (TKI) for the treatment of wet age-related macular degeneration (wet AMD).
- The data showed the TKI insert was similar in efficacy to an injection of an FDA-approved AMD biologic in preventing choroidal neovascularization (formation of new blood vessels) and reducing vascular leakage.
- Based on the encouraging results, the company intends to advance the Durasert TKI insert into clinical development.
- TKIs are currently used to treat cancer, but some inhibit a growth factor called PDGF (platelet-derived growth factor) which plays a key role in blood vessel formation. The TKI used by pSivida inhibits both PDGF and VEGF (vascular endothelial growth factor). AMD meds Lucentis (ranibizumab) and Eylea (aflibercept) are both VEGF inhibitors. In cancer, TKIs are taken orally because systemic administration is too toxic. PSivida's approach aims to deliver a TKI dose directly to the retina that is 1,000 times less that the dose used to treat cancer.
- Related tickers: (OTCQX:RHHBY -1.5%)(REGN -0.5%)
Thu, May 5, 9:12 AM
- Gainers: SYNC +143%. LGCY +31%. AAWW +27%. EPE +21%. FCEL +19%. WTW +15%. DNR +14%. ZNGA +14%. CHK +13%. BCEI +12%. UNXL +12%. ARRS +10%. CRC +10%. CLMT +9%. ORIG +9%. QRVO +8%. GSV +8%. HMY +8%. VNR +7%. MEET +7%. SDRL 7%. CLR 6%. SGYP 6%. OAS 5%. REGN 5%. BABA 5%. AUY 5%.
- Losers: PTX -37%. FRSH -27%. SQNM -19%. FIT -13%. EBIO -11%. LB -10%. WFT -9%. SEAS -8%. ABC -8%. CTL -5%.
Thu, May 5, 7:35 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) Q1 results ($M): Total Revenues: 1,201 (+38.0%); EYLEA U.S. Sales: 781 (+44.4%); EYLEA Ex. U.S. Sales: 419 (+43.5%); Sanofi Collaboration Revenue: 219.7 (+26.7%); Bayer Collaboration Revenue: 179.6 (+45.1%); Praluent Sales: 13.0.
- Net Income: 165.7 (+118.0%); Non-GAAP Net Income: 292.8 (-12.7%); EPS: 1.45 (+119.7%); Non-GAAP EPS: 2.57 (-10.8%). Q1 Consensus: EPS of $2.58 on revenues of $1.18B.
- 2016 Guidance: EYLEA U.S. Sales Growth: 20 - 25%; Sanofi reimbursement of commercialization-related expenses: $320M - 370M.
- Q2 Consensus: EPS of $2.73 on revenues of $1.24B.
- Shares are up 4% premarket but only on 76 shares.
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. 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, 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%.
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.
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)
Nov. 5, 2015, 10:32 AM
- Thinly-traded nano cap Eyegate Pharmaceuticals (EYEG +68.1%) rockets up on a 13x surge in volume, albeit on turnover of only 220K shares, in response to its announcement of interim data on the effects of iontophoretic delivery of its EGP-437 ophthalmic solution on patients with macular edema.
- The data from the ongoing Phase 1b/2a study show that iontophoresis, a non-invasive process that uses low-level electrical current to deliver the drug, can deliver EGP-437 to the back of the eye. This potentially represents a significant route-of-administration advantage over an injection into the eye (e.g. Regeneron's (REGN) EYLEA).
- CEO Stephen From says, "The interim results of the trial are highly promising and suggest the ability of the EyeGate II Delivery System to deliver drug to the posterior segment of the eye....We look forward to additional data from the extension of this trial, which we expect in mid-2016." The extension phase, set to commence in December, will recruit an additional 15 patients with a modified dosing regimen, three days at the same iontophoretic dose.
Oct. 12, 2015, 8:38 AM
- Eli Lilly (NYSE:LLY) is down 10% premarket on robust volume in response to its announcement that it has terminated the development of evacetrapib for the treatment of high-risk atherosclerotic cardiovascular disease due to lack of efficacy. Its decision was based on a review by the independent data monitoring committee.
- The move will result in a Q4 charge to R&D expense of up to $90M ($0.05 per share after tax). The company will incorporate the change in its 2015 guidance that it will provide during its earnings call on October 22.
- SVP and President of Lilly Bio-Medicines David Ricks says, "We're obviously disappointed in this outcome, as we hoped the evacetrapib would offer an advance in treatment for people with high-risk cardiovascular disease. We'll be working with investigators to appropriately conclude these trials. We remain confident in our pipeline as we prepare for launches in other therapeutics areas with significant unmet needs."
- Related tickers and status premarket: (NASDAQ:REGN) +4%; (NASDAQ:AMGN) +3%; (NASDAQ:ESPR) +14%; (NYSE:SNY) +1%.
Oct. 6, 2015, 6:44 PM
- Leading pharmacy benefits manager Express Scripts (ESRX -1%) has settled an investor debate about which pricey cholesterol drug it will cover -- by saying it will cover both of them.
- Praluent, from Regeneron (REGN -2.9%) and Sanofi (SNY -0.7%), and Repatha, from Amgen (AMGN -1.8%), will both be included on Express Scripts' formulary. Each of the PCSK9 inhibitors is at least $14,000/year, significantly higher than the cost of now-generic statins, though more effective.
- The drugs are injectables that dramatically lower LDL (the "bad cholesterol").
- Express Scripts has said that the drugs won't be "budget busters," and that most prescriptions are getting rejected because patients don't meet medical criteria.
- In after-hours action: ESRX flat; REGN +0.1%; SNY +0.8%; AMGN flat.
Sep. 30, 2015, 12:49 PM
- Bruised and battered biotech investors get some welcome buying today as bargain hunters open their wallets. The iShares Nasdaq Biotech Index Fund (IBB +2%) is up nicely, albeit on average volume.
- Key tickers: (AMGN +1.6%)(BIIB +2.5%)(GILD +1%)(CELG +0.7%)(DEPO +12.4%)(HZNP +8.6%)(NVO +0.7%)(AGN +4.9%)(VRX +6.4%)(REGN +0.9%)(TEVA +2%)(SHPG +2.6%)
Sep. 27, 2015, 8:59 AM
- The $8B iShares Nasdaq Biotechnology ETF (NASDAQ:IBB) fell 4.9% on Friday and 13% for the week - its worst weekly performance since the height of the financial panic seven years ago. Many biotech ETFs eat the same cooking - Gilead (NASDAQ:GILD), Amgen (NASDAQ:AMGN), Biogen (NASDAQ:BIIB), and Regeneron (NASDAQ:REGN) among the popular names - and FBT, XBI, and BBP fell in amounts similar to IBB.
- The news flow was relatively quiet late in the week, but Hilary Clinton's promise Monday to clamp down on drug prices set things in negative motion for the momo sector.
- Barron's Chris Dieterich reminds that a flood of biotech IPOs in recent years has filled the small cap universe with these highly speculative names, and biotech now makes up 7% of the iShares Russell 2000 Index (NYSEARCA:IWM). Indeed. The IWM fell 3.7% for the week, nearly tripling the decline of the S&P 500.
- ETFs: IWM, TZA, TNA, UWM, VB, VBK, URTY, SCHA, TWM, IWO, RWM, SRTY, VTWO, RCG, JKJ, VTWG, TWOK, FYX, JKK, EWRS, ZSML, FYC, SMLL, RYRSX
Aug. 31, 2015, 7:53 AM
- The Medicines Company (NASDAQ:MDCO) jumps 20% premarket on average volume in response to development partner Alnylam's (NASDAQ:ALNY) announcement that its investigational RNAi therapeutic, ALN-PCSsc, lowered LDL-C (bad cholesterol) up to 83% with a mean maximum reduction of up to 64% (+-5%) in an early stage study, results comparable to Amgen's (NASDAQ:AMGN) Repatha (evolocumab) and Sanofi (NYSE:SNY) and Regeneron's (NASDAQ:REGN) Praluent (alirocumab). The data were presented at the ESC Congress in London.
- What's notable in this case is the difference in dosing regimens. ALN-PCSsc was administered in one subcutaneous dose that was effective for over 140 days, giving it the potential for once per quarter or twice per year administration. Praluent is dosed once every two weeks and Repatha once every two weeks or once per month at a higher dose.
- ALN-PCSsc turns off PCSK9 synthesis in the liver. This is a different mechanism of action compared to Praluent and Repatha, both of which bind to PCSK9 in the blood.
- The Medicines Company will take the lead in developing ALN-PCSsc under the ORION Program. A Phase 2 study will commence by the end of the year and a Phase 3 trial is planned for 2017. The clinical development will include comparisons to the anti-PCSK9 monoclonal antibodies.
- The companies will host a conference call this morning at 9:30 am ET to discuss the results and their development plan.
Aug. 14, 2015, 7:16 AM
- Based on additional analyses of the data from a Phase 2a clinical trial in wet age-related macular degeneration, Avalanche Biotechnologies (NASDAQ:AAVL) decides not to proceed to Phase 2b with its lead product candidate AVA-101. Instead, it will conduct further preclinical studies to clarify the optimal dose and delivery of AVA-101 and AVA-201 compared to standard-of-care anti-VEGF protein therapy before advancing the best candidate back into the clinic. The process should be completed by the end of the year.
- The company's decision shouldn't be a surprise. The stock plummeted 40% in June after the company reported less-than-expected results from the Phase 2a study.
- The value proposition of AVA-101, a gene therapy that contains a gene that encodes a naturally occurring anti-VEGF protein, is a single subretinal injection compared intravitreal (inside the eye) injections as frequent as once per month for Regeneron's (NASDAQ:REGN) Eylea and Roche's (OTCQX:RHHBY) Lucentis.
- Shares are down 14% premarket on light volume.
- Previously: Avalanche Bio plummets 40% after hours on less-than-expected AVA-101 data; chances dim for pick up by Regeneron (June 15)
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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