Sanofi(SNY)- NYSE
  • Today, 12:52 PM
    • Singapore authorities have identified 41 Zika cases that were transmitted locally, and warned that they expect to find more.
    • The cases appear to be the largest single beachhead the virus has made in Asia in the current epidemic, which has also been detected in countries like Bangladesh, Malaysia and the Philippines.
    • On Thursday, China added the U.S. to a list of Zika-infected countries, worrying U.S. exporters, who fear they will be required to fumigate containers destined for Chinese ports.
    • Related tickers: SNY, ABT, INO, AEMD, XON, CEMI, BCRX, TMO, OTCQB:GOVX, OSUR
    | Today, 12:52 PM | 5 Comments
  • Fri, Aug. 26, 11:01 AM
    • The FDA revises its guidance on screening whole blood and blood components for the Zika virus. It now recommends all U.S. states and territories implement testing to ensure the safety of the blood supply. Collection/processing centers can use either an investigational test authorized by the FDA under an IND or a licensed test when available.
    • In February, the agency recommended the safety measure only in areas with active Zika virus transmission. All such areas (i.e., FL and Puerto Rico) are now in compliance with the guidance.
    | Fri, Aug. 26, 11:01 AM | 1 Comment
  • Mon, Aug. 22, 3:27 PM
    • At the FDA's request, Sanofi (SNY -0.7%) submits additional information to the agency pertaining to the pen delivery device for its investigational once-daily fixed-dose combination of basal insulin glargine 100 Units/ml and GLP-1 receptor agonist lixisenatide, branded as iGlarLixi, for the treatment of adults with type 2 diabetes. The action constitutes a major amendment to the New Drug Application (NDA) so the FDA's action date (PDUFA) is automatically extended three months to November.
    • On May 25, the FDA's Advisory Committee voted 12 - 2 backing approval.
    • Read now Sanofi Should Be Thinking Longer Duration In GLP-1s
    | Mon, Aug. 22, 3:27 PM | 10 Comments
  • 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, 9:49 AM | 10 Comments
  • 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.
    | Mon, Aug. 22, 9:04 AM | 1 Comment
  • Sun, Aug. 21, 6:39 PM
    • Pfizer (NYSE:PFE) is close to a $14B deal to acquire cancer drugmaker Medivation (NASDAQ:MDVN), FT says.
    • The price is about 1/3 higher than Medivation's closing price on Friday.
    • Pfizer would be beating out rivals including Celgene (NASDAQ:CELG), Gilead (NASDAQ:GILD), Sanofi (NYSE:SNY), Merck (NYSE:MRK) and AstraZeneca (NYSE:AZN), who have been pursuing Medivation for months.
    • Medivation has already rejected two "inadequate" bids from Sanofi, the last for $11B ($58/share).
    • Shares of Medivation have more than doubled in the last six months.
    • Medivation makes the leading prostate cancer drug, Xtandi, which is expected to generate $5.7B in annual revenue by 2020.It is also developing an experimental drug called Talazoparib, which is designed to stop tumor cells from multiplying by damaging their DNA.
    • Update: It's official. Pfizer will acquire Medivation for $81.50 a share (~$14B). The deal will be immediately accretive to Pfizer's non-GAAP EPS, adding ~$0.05 in the first full year after the transaction closes, expected by Q4. Its 2016 guidance will be unaffected. The deal will be financed with existing cash. Pfizer will host a conference call this morning at 9:00 am ET to discuss the acquisition.
    | Sun, Aug. 21, 6:39 PM | 92 Comments
  • Sun, Aug. 21, 8:56 AM
    • Federal health officials are warning pregnant women and their partners not to travel to Miami Beach after Florida confirmed that the mosquito-borne Zika virus was active in the popular tourist destination.
    • The CDC also suggested that pregnant women who are especially worried about Zika exposure might consider avoiding all of Miami-Dade County.
    • Other fears? In addition to causing the birth defect microcephaly, a new study from Rockefeller University and La Jolla Institute for Allergy and Immunology suggests the virus may cause brain damage in adults as well.
    • Related tickers: SNY, INO, AEMD, XON, CEMI, BCRX, TMO, OTCQB:GOVX
    | Sun, Aug. 21, 8:56 AM | 44 Comments
  • Thu, Aug. 18, 6:43 AM
    • Portola Pharmaceuticals (NASDAQ:PTLA) plummets 18% premarket on increased volume in response to its announcement that it received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) seeking approval of anticoagulant reversal agent AndexXa (andexanet alfa).
    • The company says most of the requested information relates to manufacturing although the agency also wants more data to support inclusion of edoxaban [Daiichi Sankyo's (OTCPK:DSKYF)(OTCPK:DSNKY) Savaysa] and enoxaparin [Sanofi's (NYSE:SNY) LOVENOX] in the label. It also stated that it needs more time to complete its review of the clinical amendments to Portola's post-marketing commitments that were submitted recently.
    • Andexanet alfa is a modified human Factor Xa molecule that acts as a decoy to target and sequester, with high specificity, Factor Xa inhibitors in the blood. Once bound, the Factor Xa inhibitors are unable to inhibit Factor Xa and normal hemostatic processes are restored.
    • Management will host a conference call this morning at 8:30 am ET to discuss the situation.
    • Previously: Portola down 10% ahead of FDA action on AndexXa (Aug. 17)
    | Thu, Aug. 18, 6:43 AM | 55 Comments
  • Wed, Aug. 17, 1:30 PM
    • In-play Medivation (MDVN +2.1%) perks up on modestly higher volume on the news that Merck (MRK -0.3%) has joined Sanofi (SNY -0.5%), Celgene (CELG +0.3%), Gilead Sciences (GILD +1.7%), Pfizer (PFE +0.6%) and AstraZeneca (AZN -0.2%) as potential acquirers.
    • Medivation has already rejected two "inadequate" bids from Sanofi, the last for $11B ($58/share).
    | Wed, Aug. 17, 1:30 PM | 36 Comments
  • Sun, Aug. 14, 1:03 PM
    • Three new non-travel cases of the Zika virus have been found in Florida, including another person who doesn't live in the one-square-mile area believed to be the hub of local transmission, bringing the number of cases confirmed there so far to 28.
    • The U.S. Centers for Disease Control and Prevention issued a warning two weeks ago for pregnant women to avoid this area of Miami. Zika has been shown to cause birth defects, including microcephaly, which causes severe developmental problems.
    • Related tickers: SNY, INO, AEMD, XON, CEMI, BCRX, TMO, OTCQB:GOVX
    | Sun, Aug. 14, 1:03 PM | 24 Comments
  • Fri, Aug. 12, 4:38 AM
    • The Obama administration will transfer a total of $81M within the Department of Health and Human Services to work on Zika vaccines amid an increase in cases in the United States.
    • The money is intended to keep research going despite the lack of funding from U.S. lawmakers, who left for summer recess before allocating funds to halt the spread of the virus.
    • Related tickers: SNY, INO, AEMD, XON, CEMI, BCRX, TMO, OTCQB:GOVX
    | Fri, Aug. 12, 4:38 AM | 23 Comments
  • Sun, Aug. 7, 12:40 PM
    • As fears mount about the impacts of Zika, Canaccord's Tony Dwyer is warning that the health crisis (compounded with Italian bank issues, a more hawkish Fed and energy price weakness) could morph into the Ebola scare that enveloped the market two years ago.
    • The S&P 500 slipped 1.7% off its peak once the first U.S. Ebola case was reported in September 2014, and by the time the third American case was diagnosed, the market was already down 7%.
    • "Obviously, no two situations are exactly alike, but this is pretty close," concluded Dwyer. "I'm not looking for anything like a 10% decline... but this could be the catalyst we've been looking for."
    • Related tickers: SNY, INO, AEMD, XON, CEMI, BCRX, TMO, OTCQB:GOVX
    | Sun, Aug. 7, 12:40 PM | 58 Comments
  • Thu, Aug. 4, 5:01 AM
    • U.S. government researchers have begun their first clinical trial of a Zika vaccine while the Obama administration told lawmakers funds to fight the virus would run out in the coming weeks due to congressional inaction.
    • The number of locally spread Zika cases has jumped to 15 in Florida and the amount of U.S. states affected has reached 45. As of July 27, 1,658 travel associated cases of Zika were reported across the continental U.S. and Hawaii.
    • Related tickers: SNY, INO, AEMD, XON, CEMI, BCRX, TMO, OTCQB:GOVX
    | Thu, Aug. 4, 5:01 AM | 21 Comments
  • Tue, Aug. 2, 2:38 AM
    • Federal health officials have advised pregnant women to avoid a Miami neighborhood - marking the first time the CDC has warned against travel to any area within the continental U.S. - as a Zika outbreak led to 10 more local cases.
    • Other troubling news... Director Tom Frieden said that extensive spraying of insecticides in the area over the past several weeks has not reduced the local population of mosquitoes capable of transmitting the virus.
    • Related tickers: SNY, INO, AEMD, XON, CEMI, BCRX, TMO, OTCQB:GOVX
    | Tue, Aug. 2, 2:38 AM | 38 Comments
  • Fri, Jul. 29, 10:54 AM
    • Sanofi (SNY -0.1%) Q2 results (€M): Revenues: 8,868 (-4.3%); Operating Income: 1,436 (-25.9%); Net Income: 1,158 (-11.1%); Non-GAAP Net Income: 1,680 (-8.7%); EPS: €0.90 (-10.0%); Non-GAAP EPS: €1.31 (-7.1%); Quick Assets: 6,076 (-33.6%).
    • Sales by Global Business Units: Sanofi Genzyme (Specialty Care): 1,245; Diabetes & Cardiovascular: 1,603; General Medicines & Emerging Markets: 4,498; Sanofi Pasteur (Vaccines): 797; Merial (Animal Health): 725.
    • Key Product Sales: Lantus: 1,465; Lovenox: 414; Plavix: 392; Aubagio: 315; Renvela/Renagel: 208; Cerezyme: 199; Allegra: 39.
    • 2016 Guidance: EPS: to be stable at CER; currency impact: -4%.
    | Fri, Jul. 29, 10:54 AM
  • Fri, Jul. 29, 10:07 AM
    • Health officials in Florida confirm that the state is the first in the U.S. to have local cases of transmission of the Zika virus.
    • Four individuals with the illness had not traveled to Zika-infected areas or had any other direct exposure to the virus.
    • Related tickers: SNY, INO, AEMD, XON, CEMI, BCRX, TMO, OTCQB:GOVX.
    | Fri, Jul. 29, 10:07 AM | 32 Comments
Company Description
Sanofi engages in the research, production and distribution of pharmaceutical products. It operates through the following segments: Pharmaceuticals, Human Vaccines, and Animal Health. The Pharmaceuticals segment includes research, development, production and sales activities relating to... More
Sector: Healthcare
Industry: Drug Manufacturers - Major
Country: France