Sanofi SA

NASDAQ:SNYUnited States

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• Sanofi, Regeneron's Dupixent Receives Recommendation for Approval From European Medicines Agency Committee, from 4 hours ago by MT Newswires

  4 hours ago by MT Newswires
  Companies Mentioned: REGN, SNY
  07:32 AM EDT, 05/31/2024 (MT Newswires) -- The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of dupilumab, known as Dupixent, in the European Union as an add-on maintenance treatment for adul...

• Press Release: Sanofi launches 2024 global Employee Stock Purchase Plan, from 5 hours ago by Dow Jones

  5 hours ago by Dow Jones
  Companies Mentioned: SNY
  
  Press Release: Sanofi launches 2024 global Employee Stock Purchase Plan
  
  Sanofi launches 2024 global Employee Stock Purchase Plan
  
  Paris, May 31, 2024. Sanofi's global employee shareholder plan, Action 2024, opens on June 4, 2024, to around 80,000 employees in 56 countries. Now in its 10(th) year, the program demonstrates the ongoing commitment of Sanofi and its Board of Directors to secure that employees benefit from the company growth and success.
  

• Regeneron Pharmaceuticals, Sanofi Say Dupixent FDA Application Decision Delayed by 3 Months, from 6 hours ago by MT Newswires

  6 hours ago by MT Newswires
  Companies Mentioned: REGN, SNY
  04:49 AM EDT, 05/31/2024 (MT Newswires) -- Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) said Friday the US Food and Drug Administration has extended until Sept. 27 the action date on the biologics license application for Dupixent as a supplemen...

• DJ Sanofi's Dupixent Drug Review Date Extended by Three Months in the U.S., from 10 hours ago by Dow Jones

  10 hours ago by Dow Jones
  Companies Mentioned: REGN, SNY
  By Ian Walker French pharmaceutical company Sanofi said that the priority review date in the U.S. for its chronic obstructive pulmonary disease treatment, Dupixent has been extended, but stressed that there weren't any concerns over the drug. The U.S. Food and Drug Administration asked for more information from recent trials of Dupixent, and said that the extra data constitutes a major amendment to the supplemental biologics license application. It has therefore extended the date for its review to Sept. 27. "Sanofi and Regeneron are confident that the additional analyses strongly support the approval of Dupixent in COPD with evidence of type 2 inflammation, and are committed to working with the FDA to bring Dupixent to patients living with uncontrolled COPD as quickly as possible," the companies said. Sanofi and Regeneron are jointly developing Dupixent under a global collaboration agreement. Separately, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended Dupixent for European Union approval. The EU is expected to announce a final decision on the Dupixent application in the coming months. Write to Ian Walker at ian.walker@wsj.com (END) Dow Jones Newswires May 31, 2024 01:34 ET (05:34 GMT)

• Dupixent(R) (dupilumab) Recommended for EU Approval by the CHMP to Treat Patients with COPD, from 10 hours ago by Dow Jones

  10 hours ago by Dow Jones
  Companies Mentioned: REGN, SNY
  
  effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron's Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron's business; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA(R) (aflibercept) Injection), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2023 and its Form 10-Q for the quarterly period ended March 31, 2024. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.