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Regeneron Pharmaceuticals, Inc. (REGN)

  • Wed, May 20, 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%)
  • Nov. 14, 2014, 12:00 PM
    • The money continues to flow out of biotech. The iShares NASDAQ Biotech Index (NASDAQ:IBB) is down 2%. The index is down almost 5% since the peak of 302.98 on October 31.
    • A sampling of moves today: (BIIB -4.3%)(CELG -3.4%)(AMGN -1.6%)(GILD -1.6%)(REGN -1.6%)(ALXN -2.3%)(VRTX -0.1%)
  • Nov. 4, 2014, 9:15 AM
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  • Oct. 17, 2014, 9:20 AM
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  • Jul. 30, 2014, 9:09 AM
  • Jul. 29, 2014, 7:25 PM
    • Following positive Phase 3 trial data, the FDA has approved Regeneron's (NASDAQ:REGN) Eylea for the treatment of diabetic macular edema (DME).
    • Eylea is already available in the U.S. for the treatment of neovascular age-related macular degeneration and macular edema following central retinal vein occulusion, following 2011 and 2012 approvals.
    • Europe's CHMP has given a positive opinion for approving Eylea for DME treatment, and regulatory submissions for DME treatment have also been made in Japan, Asia-Pac, and Latin America.
    • REGN +3.1% AH.
    • Prior Eylea coverage
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  • Feb. 24, 2014, 9:18 AM
    • The FDA has accepted Regeneron's (REGN +3.3%) application to expand the use of its Eylea therapy to treat Macular Edema Following Branch Retinal Vein Occlusion, a common vascular disease among the elderly that is caused by a blockage of one of the small veins that carry blood away from the retina.
    • Regeneron's application follows a successful Phase III trial.
    • Eylea has already been authorized for other indications, including wet age-related macular edema.
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  • Feb. 10, 2014, 8:16 AM
    • Regeneron's (REGN +3.15%) Eylea treatment improved vision and maintained that improvement over two years in a Phase III trial of patients with diabetic macular edema (DME).
    • DME is a leading cause of blindness in younger and middle-aged adults; Eylea could potentially treat over 6M sufferers globally.
    • Regeneron and partner Bayer (BAYRY) are waiting for U.S. and EU approval of Eylea to treat DME; the therapy has already been authorized for other indications, including wet age-related macular edema. (PR)
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  • Jan. 15, 2014, 9:55 AM
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  • Jan. 14, 2014, 12:43 PM
    • Roth Capital is out with a bullish note on Regeneron (REGN +9.1%) on the heels of the company's announcement of a new development agreement with Bayer.
    • Here's analyst Joseph Pantginis, commenting: "Preclinical studies have suggested that blocking both PDGFR-beta and vascular endothelial growth factor (VEGF) can provide additional benefit over anti-VEGF treatment (such as EYLEA) alone in wet AMD."
    • Buy rating maintained.
    • Price target is $362.
    • In other company news, REGN has announced a collaboration with Geisinger Health System under which the companies will "study the genetic determinants of human disease." Additionally, Sanofi (SNY) has amended its investor agreement with REGN and retains the right to "acquire up to 30% of REGN's outstanding common stock and Class A stock [while gaining] the right to nominate a single independent director to the Regeneron Board of Directors upon reaching 20% ownership [stake]."
  • Nov. 6, 2013, 2:21 PM
    • Goldman's Terence Flynn tweaks his Regeneron (REGN -3.6%) numbers a bit following Q3 results.
    • Flynn's new estimates: FY14 Eylea sales of $1.88B. That's down from $1.98B previously "to reflect single digit growth in H1 2014 (based on current trends) followed by an acceleration in H2 2014, which assumes Eylea receives priority review for DME."
    • New EPS targets for FY14/15/16: $9.89/$14.35/$16.19.
    • Buy rating maintained.
    • Price target cut to $353 from $355.
  • Nov. 5, 2013, 1:31 PM
    • No surprise here. Deutsche's Robyn Karnauskas keeps Regeneron (REGN +6.7%) at Buy following strong Q3 results anchored by Eylea sales.
    • "Q3 Eylea sales were ahead of expectations at $363M vs. $350M consensus [and] REGN raised full year Eylea U.S. guidance to $1.35-$1.375B vs. $1.3-$1.35B previous," Karnauskas notes.
    • Karnauskas also revises branch retinal vein occlusion success probability to 100% based on Phase 3 study results released late last month.
    • Price target raised to $375 from $310.
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  • Nov. 5, 2013, 8:15 AM
    • Regeneron (REGN) is 5.8% higher in premarket trading after the company easily tops estimates for Q3.
    • Revenue rises 39% Y/Y.
    • Eylea U.S. net product sales come in at $363M, that's up 49% Y/Y. Ex-U.S., Eylea sales print at $125M, up 23%.
    • Zaltrap worldwide net sales: $18M.
    • Collaboration revenues rise 29% to $223M.
    • R&D $224M versus $158M in Q3 2012. SG&A of $98M, up from $47M last year.
    • An sNDA has been submitted for DME (that's one year ahead of the original schedule). (PR)
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  • Sep. 30, 2013, 1:40 PM
    • Regeneron (REGN +2.7%) enjoys some bullish commentary out of the sell-side following the presentation of Phase 3 Eylea data in DME at the Retina Society's annual meeting. (full presentation)
    • "The data clearly supports label expansion with blockbuster potential even competing with approved Lucentis (RHHBY.OB, NVS) and off-label Avastin," Piper's Edward Tenthoff says, before going on record with predictions of $56M and $177M in sales in H2 2014 and FY15 for the new indication, respectively. Price target raised to $360 from $336.
    • Goldman is out with similar comments, saying the VIVID/VISTA data "were in line with ... expectations and [should] support approval for a broader label and drive uptake/growth.” Price target raised to $355 from $329.
    • Also: Oppenheimer's David Ferreiro lifts his target to $310 from $300.
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  • Sep. 18, 2013, 11:46 AM
    • Regeneron Pharmaceuticals (REGN +3.7%) has been on a nice run of late thanks in part to speculation (fueled by some rather specific comments Chris Viehbacher made last week) that Sanofi (SNY -0.3%) may up its 16% stake to as much as 30% (the maximum allowed under the companies' partnership).
    • REGN is extending its gains today and is set to present Phase 3 VIVID/VISTA Eylea data later this month at the Retina Society's annual meeting. (PR)
    • There's also chatter that Goldman's Terence Flynn has upped his price target on the shares to $329 from $298.
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  • Aug. 22, 2013, 11:04 AM
    • Regeneron Pharmaceuticals (REGN +2.5%) moves up after being initiated at Oppenheimer with an Outperform rating and a $300 price target.
    • The stock has been pummelled this month, losing nearly 14% on the back of a mixed Q2 report.
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Company Description
Regeneron Pharmaceuticals Inc is a fully integrated biopharmaceutical company. It discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.
Sector: Healthcare
Industry: Biotechnology
Country: United States