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  • Fri, Dec. 2, 8:26 AM
    • MyoKardia (NASDAQ:MYOK) receives a milestone payment of $25M from Sanofi (NYSE:SNY) triggered by the submission of an Investigational New Drug (IND) application to the FDA  for MYK-491 in dilated cardiomyopathy (DCM). The payment is in accordance with the companies' 2014 research agreement.
    • An early-stage clinical trial should commence in H1 2017. Top-line data from a single ascending dose study are expected in Q3 2017.
    • The therapeutic rationale of MYK-491 is that it may increase muscle contraction to restore cardiac output.
    | Fri, Dec. 2, 8:26 AM
  • Tue, Nov. 29, 6:49 AM
    • Actelion (OTCPK:ALIOY) shares are down almost 6% in Zurich on reports that it is resisting Johnson & Johnson's (NYSE:JNJ) $17B offer for an outright sale. The aim of the complicated deal structure previously reported is to enable the company to remain independent while allowing J&J's U.S. group to retain a major equity stake.
    • Lurking in the background is Sanofi (NYSE:SNY) which could jump into the mix considering its widely-known interest in acquisitions since it plans to divest its generics business. Sanofi shares are up over 1% in Paris.
    | Tue, Nov. 29, 6:49 AM | 3 Comments
  • Tue, Nov. 29, 3:12 AM
    • Texas has reported its first home-grown case of Zika virus - making it the second U.S. state with mosquitoes spreading the disease.
    • It's a long-feared development but not a surprising one. Like Florida, South Texas is home to the Aedes aegypti mosquitoes that spread Zika and also hosts many travelers to and from countries where the virus has been spreading.
    • Related tickers: SNY, ABT, INO, AEMD, XON, CEMI, BCRX, TMO, OSUR, OTCQB:GOVX
    | Tue, Nov. 29, 3:12 AM | 6 Comments
  • Wed, Nov. 23, 2:40 PM
    • In a note to investors, Leerink analyst Geoff Porges says the list of deficiencies at Sanofi's (SNY -1.3%) "fill and finish" Le Trait facility cited by FDA inspectors in July is "longer and somewhat more concerning" than anticipated and could risk delaying the market introduction of dupilumab, a systemic therapy for the treatment of atopic dermatitis (AD), being co-developed with Regeneron Pharmaceuticals (REGN).
    • Leerink obtained a copy of the Form 483 under a Freedom of Information Act request. The document is used by FDA inspectors to record deficiencies observed during an on-site inspection.
    • On the plus side, there were apparently no observations related to product quality.
    • If, for some reason, Sanofi is unable to resolve the deficiencies in a timely manner, an alternative fill and finish facility may need to be used.
    • 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's action (PDUFA) date is March 29, 2017.
    | Wed, Nov. 23, 2:40 PM | 10 Comments
  • Mon, Nov. 21, 7:51 PM
    • The FDA approves Sanofi's (NYSE:SNY) Soliqua 100/33 (insulin glargine & lixisenatide injection) 100 Units/mL & 33 mcg/mL for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 Units/day) or lixisenatide.
    • Soliqua is a once-daily fixed-dose combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide.
    • The company's marketing application in Europe should be approved December or early January.
    | Mon, Nov. 21, 7:51 PM
  • Thu, Nov. 17, 10:12 AM
    • The first patient has been enrolled in a UK-based Phase 3 clinical, COMET, assessing Sanofi Genzyme's (SNY +0.4%) NeoGAA, a second-generation enzyme replacement therapy, for the treatment of Pompe disease.
    • About 96 subjects will be recruited in the randomized, double-blind three-year study. The primary endpoint will measure the impact of NeoGAA on respiratory muscle strength.
    | Thu, Nov. 17, 10:12 AM
  • Thu, Nov. 17, 7:59 AM
    • The large-scale Phase 3 study investigating the effect of PCSK9 inhibitor Praluent (alirocumab) on cardiovascular outcomes in at-risk patients will continue as planned based on the recommendation from the independent Data Monitoring Committee after it completed its second pre-specified interim analysis. The study involves more than 18K patients from 57 countries.
    • Relevant tickers: (NASDAQ:REGN)(NYSE:SNY)
    • Regeneron is down 4% premarket on modest volume. Sanofi is up a fraction.
    | Thu, Nov. 17, 7:59 AM | 2 Comments
  • Wed, Nov. 16, 9:13 AM
    • Results from a Phase 3 clinical trial, SARIL-RA-MONARCH, assessing Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi's (NYSE:SNY) sarilumab compared to AbbVie's (NYSE:ABBV) HUMIRA (adalimumab) in adult patients with rheumatoid arthritis (RA) showed sarilumab to be superior in improving RA symptoms. The data will be presented today at the American College of Rheumatology Annual Meeting in Washington, D.C.
    • SARIL-RA-MONARCH enrolled 369 adults with active RA who failed to respond adequately or were intolerant of or were inappropriate candidates for methotrexate. They were randomized to receive either sarilumab monotherapy (200 mg every two weeks subcutaneously) or adalimumab (40 mg every two weeks subcutaneously). The primary endpoint was the change from baseline to week 24 in a scale called DAS28-ESR, a measure of RA activity via the evaluation of 28 joints for tenderness and swelling, a general health assessment and ESR (erythrocyte sedimentation rate), a simple laboratory test for inflammation.
    • Sarilumab demonstrated superiority to adalimumab as measured by DAS28-ESR (-3.28 vs. -2.20; p<0.0001). The rates of DAS28-ESR remission also favored sarilumab (26% vs. 7%; p<0.0001).
    • It also beat adalimumab in terms of the proportion of patients who achieved ACR20 (20% improvement in RA symtoms) (72% vs. 58%; p<0.01), ACR50 (45% vs. 29%; p=0.0017) and ACR70 (23% vs. 11%; p=0.0036).
    • The incidence of adverse events were 64% for both groups. Serious adverse events were observed in 5% of the sarilumab subjects and 7% in the adalimumab subjects. The incidence of infections were similar (29% for sarilumab vs. 28% for adalimumab). Neutropenia (low level of a type of white blood cell called neutrophils) was more common with sarilumab (14%) than adalimumab (1%).
    • Sarilumab in a human monoclonal antibody that inhibits the inflammatory activity of RA by binding to the interleukin-6 (IL-6) receptor. IL-6 is the most abundant cytokine in the serum and synovial fluid of RA sufferers and is correlated with disease activity and joint destruction.
    • Sanofi's U.S. marketing application is currently under review. The FDA issued a CRL last month citing manufacturing deficiencies at the Sanofi site that will "fill and finish" the product. Sanofi has responded to the agency and is working with the regulator to promptly address the issues.
    | Wed, Nov. 16, 9:13 AM | 22 Comments
  • Mon, Nov. 14, 9:25 AM
    • Alnylam Pharmaceuticals (NASDAQ:ALNY) announces that global alliance partner Sanofi Genzyme (NYSE:SNY) will opt-in to co-develop and co-commercialize RNAi therapeutic fitusiran for the treatment of hemophilia and rare bleeding disorders in the U.S., Canada and Western Europe. Sanofi Genzyme had previously elected to exclusively develop fitusiran in their rest-of-world territories. A Phase 3 study is on tap to commence in early 2017.
    • Under the terms of the alliance, Alnylam will receive up to $75M in development and regulatory milestones, including $25M upon the initiation of the Phase 3 trial. It will also earn tiered royalties up to 20% on fitusiran sales in Sanofi Genzyme's exclusive territory. Profits will be shared equally in the co-commercialization territory.
    • Sanofi Genzyme has elected to pass on ALN-AS1, an investigational RNAi therapeutic for acute hepatic porphyrias.
    • The companies formed their alliance in January 2014 to accelerate and expand the development and commercialization of RNAi therapeutics worldwide.
    | Mon, Nov. 14, 9:25 AM
  • Fri, Nov. 11, 9:30 AM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending the use of Novartis' (NYSE:NVS) Arzerra (ofatumumab), in combination with the chemo agents fludarabine and cyclophosphamide, for the treatment of adult patients with relapsed chronic lymphocytic leukemia (CLL).
    • The original European indication specifies the use of Arzerra, in combination with the chemo agents chlorambucil or bendamustine, in treatment-naive CLL patients who cannot be treated with fludarabine and in CLL patients who do not respond to fludarabine and alemtuzumab [Sanofi's (NYSE:SNY) LEMTRADA].
    • A final decision from the European Commission usually takes ~60 days.
    • Novartis is developing ofatumumab under a collaboration with Genmab A/S (OTC:GNMSF)(OTCPK:GMXAY).
    | Fri, Nov. 11, 9:30 AM | 1 Comment
  • Fri, Nov. 11, 9:11 AM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Sanofi's (NYSE:SNY) Suliqua (iGlarLixi) for the treatment of adults with type 2 diabetes. The specific indication is the use of Suliqua, in combination with metformin, for the treatment of adult type 2 diabetics to improve glycemic control when treatment with metformin alone or in combination with another oral glucose-lowering medicine or basal insulin fails to do the job.
    • Suliqua is a once-daily fixed-dose combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide.
    • A final decision from the European Commission usually takes ~60 days.
    • The company's New Drug Application (NDA) in the U.S. is currently under review.
    • Lixisenatide was invented by Zealand Pharma (OTCPK:ZLDPF). Sanofi secured global commercialization rights under a 2003 license agreement.
    | Fri, Nov. 11, 9:11 AM | 3 Comments
  • Thu, Nov. 10, 11:59 AM
    • Westport, CT-based Accelerated Pharma (Pending:ACCP) is set for its IPO of 1,888,889 shares of common stock at $8 - 10.
    • The clinical stage biopharmaceutical firm employs its genomic technology to enhance the development of pre-existing pharmaceutical products for the treatment of a range of cancers and to prospectively identify patients who may be the best responders to therapy.
    • Its lead product candidate is Picoplatin, a next-generation platinum-based chemotherapeutic. Its value proposition is less unwanted side effects and improved ability to overcome platinum resistance. Phase 2 studies in colorectal cancer and squamous head and neck cancer should commence this month.
    • Picoplatin was originally developed by a subsidiary of AstraZeneca (NYSE:AZN). It was then sold to Genzyme (NYSE:SNY) who licensed it to Poniard Pharmaceuticals. In early November 2009, Poniard announced that a Phase 3 study in small cell lung cancer failed to achieve its primary efficacy endpoint and stopped development. In 2013, Encarta (predecessor to Tallikut Pharmaceuticals) acquired certain assets from Poniard including the Genzyme license. Accelerated Pharma obtained the rights via an exclusive license with Tallikut in June 2014.
    • 2016 Financials (9 mo.)($M): Operating Expenses: 2.7 (+114.0%); Net Loss: (2.7) (-114.0%); Cash Burn: (1.7) (-43.1%).
    | Thu, Nov. 10, 11:59 AM | 1 Comment
  • Wed, Nov. 9, 3:03 AM
    • Healthcare stocks, the weakest sector this year, may become winners, as Obamacare reforms are set to be "repealed and replaced" and major legislation Clinton proposed is unlikely to be imposed on drugmakers.
    • While Trump hasn't set out a comprehensive alternative to the Affordable Care Act (which may see 22M Americans lose current coverage), he said he'll encourage competition between markets in different states.
    • Insurance stocks: UNH, AET, ANTM, CI, HUM, WCG, CNC, MOH, GTS, HQY
    • Drugmakers premarket: MYL +5.8%, NVS +3.4%, SNY +2.9%, AZN +2.4%, GSK +1.9%, PFE +1.8%, CELG +1%, ABBV, MRK, BMY, LLY, JNJ, ABT, ACET, ZTS, BIIB, REGN
    • #Election2016
    | Wed, Nov. 9, 3:03 AM | 14 Comments
  • Fri, Nov. 4, 8:37 AM
    • Sanofi's (NYSE:SNY) Genzyme unit commences a Phase 3 clinical trial, COMET, assessing its second-generation enzyme replacement therapy NeoGAA for the treatment of Pompe disease, a rare inherited disorder caused by the buildup of glycogen in cells due to a malfunctioning enzyme called acid alpha-glucosidase (GAA).
    • COMET will randomize 96 subjects to receive either NeoGAA (GZ402666) or alglucosidase alfa (Lumizyme) every two weeks during the 49-week treatment period. A 96-week open-label treatment period will follow. The primary endpoint is the change from baseline to Month 12 in percent predicted forced vital capacity in an upright position. According to ClinicalTrials.gov, the estimated study completion date is August 2020.
    • NeoGAA has been designed for enhanced receptor targeting and enzyme uptake via greater affinity for the M6P receptors on muscle cells thereby enhancing glycogen clearance and improving clinical efficacy compared to alglucosidase alfa.
    | Fri, Nov. 4, 8:37 AM
  • Thu, Nov. 3, 9:44 AM
    • The European Medicines Agency (EMA) accepts for review Mylan N.V.'s (MYL +0.7%) Marketing Authorization Application (MAA) seeking approval of its insulin glargine, a long-acting insulin analog used to treat adult type 2 diabetics and adult and pediatric type 1 diabetics.
    • Mylan co-developed the product with Bengaluru, India-based Biocon Ltd. Clinical studies showed bioequivalence to Sanofi's (SNY +1%) Lantus (insulin glargine injection 100 Units/mL).
    | Thu, Nov. 3, 9:44 AM | 3 Comments
  • Tue, Nov. 1, 7:43 AM
    • Pfizer (NYSE:PFE) eases 1% premarket on light volume in response to its Q3 earnings and to the news that it has terminated development of cholesterol lowering candidate bococizumab, an inhibitor of Proprotein Convertase Subtilisin Kexin type 9 (PCSK9).
    • The company says that after completing six studies, an emerging clinical profile of the drug has emerged that includes an unanticipated attenuation of LDL-C-lowering over time (it doesn't go down as much as expected) and a higher level of immunogenicity and injection site reactions versus other PCSK9 inhibitors. It adds that lowering cholesterol must be durable to have a long-term effect on reducing the risk of cardiovascular events like heart attack and stroke.
    • The data will be made available to study leaders for independent analysis with the aim of maximizing the clinical and scientific knowledge gained from the halted trials.
    • Pfizer will record a $0.04 charge against GAAP and non-GAAP EPS this quarter.
    • There are two PCSK9 inhibitors commercially available in the U.S.; Amgen's (NASDAQ:AMGN) Repatha (evolocumab) and Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi's (NYSE:SNY) Praluent (alirocumab). Both have been slow to gain traction in the marketplace.
    | Tue, Nov. 1, 7:43 AM