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  • Today, 7:09 AM
    • Regeneron Pharmaceuticals (NASDAQ:REGN) and development partner Sanofi (NYSE:SNY) announce that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) seeking approval of Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.
    • The U.S. marketing application is currently under FDA review with an action date of 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.
    | Today, 7:09 AM | 2 Comments
  • Yesterday, 12:00 PM
    • As a requirement of its planned acquisition of Sanofi's (SNY -0.7%) Merial animal health unit, Boehringer Ingelheim's Vetmedica divests its U.S. CYDECTIN bovine and ovine endectocide products to Bayer for an undisclosed sum. The deal should close next quarter.
    • Boehringer is acquiring Merial in an asset swap that will send its consumer healthcare business to Sanofi. The transaction was announced in December 2015.
    | Yesterday, 12:00 PM | 1 Comment
  • Yesterday, 8:42 AM
    • In a regulatory filing, MannKind (NASDAQ:MNKD) reports that former AFREZZA commercialization partner Sanofi (NYSE:SNY) (sanofi-aventis U.S., LLC) purchased $10.2M of insulin from the company on December 2 as agreed to under their previously announced settlement agreement.
    | Yesterday, 8:42 AM | 47 Comments
  • Mon, Dec. 5, 5:04 PM
    • Bloomberg reports that Sanofi (NYSE:SNY) is mulling a bid for Actelion, potentially challenging Johnson & Johnson's (NYSE:JNJ) $250-a-share offer. If so, it will be pricey. Actelion is currently valued at ~$20B.
    | Mon, Dec. 5, 5:04 PM | 11 Comments
  • Mon, Dec. 5, 2:21 PM
    • Sanofi's (SNY +2%) Genzyme unit initiates a Phase 3 clinical trial, ICARIA-MM, assessing isatuximab, an anti-CD38 monoclonal antibody, for the treatment of patients with relapsed/refractory multiple myeloma. The study will compare the combination of isatuximab + pomalidomide and dexamethasone against pomalidomide and dexamethasone alone. The primary endpoint is progression-free survival.
    | Mon, Dec. 5, 2:21 PM
  • Sun, Dec. 4, 1:58 PM
    • Interim results from an ongoing Phase 2 open-label extension study assessing Alnylam's (NASDAQ:ALNY) fitusiran in patients with hemophilia A or B without inhibitors showed clinically meaningful activity. The data were presented today at the 58th American Society of Hematology (ASH) annual meeting in San Diego.
    • As of the October 6 data cut-off, a total of 16 patients had received once-monthly subcutaneous doses of fitusiran in two dosage arms: 50 mg (n=8) and 80 mg (n=8) for up to 14 months. All were previously enrolled in a Phase 1 trial during which they received three weekly or three monthly subcutaneous doses ranging from 45 mcg/kg to 1800 mcg/kg.
    • Both dosage levels lowered average antithrombin (AT) by ~80% with average increases in thrombin approaching the lower end of the normal range in healthy people who participated in Part A of the Phase 1. In an exploratory post hoc (after the fact) analysis, treatment with fitusiran lowered median annualized bleed rate (ABR) to 1.0 from 4.0 over a median observation period of 5.7 months. 50% (n=8/16) of subjects reported zero bleeds and 69% (n=11/16) experienced zero spontaneous bleeds.
    • Fitusiran was generally well-tolerated over the study period (up to 14 months of continuous treatment). All adverse events (AEs) were mild to moderate. The most common were injection site reactions (25%). Elevations in a liver enzyme called ALT (biomarker for organ stress) greater than 3x the upper limit of normal (ULN) without concurrent elevations in bilirubin greater than 2x ULN were observed in three (19%) patients, all with a history of hepatitis C virus infection. There were no drug-related serious adverse events, no AE-related discontinuations, no thromboembolic events and no laboratory evidence of pathologic clot formation through the cut-off date.
    • A Phase 3 study should commence in early 2017. The product candidate is being co-developed and will be co-commercialized with Sanofi Genzyme (NYSE:SNY).
    • Fitusiran is an investigational small interfering RNA therapeutic targeting antithrombin (AT), a naturally occurring protein that interferes with certain enzymes involved in blood clotting. Lowering AT promotes the generation of an enzyme called thrombin which plays an essential role in clotting.
    | Sun, Dec. 4, 1:58 PM | 2 Comments
  • 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