NewAmsterdam Pharma and Menarini's Obicetrapib Receives EMA Validation for Marketing Authorization Applications in Europe

Reuters
2025/08/18
NewAmsterdam Pharma and Menarini's Obicetrapib Receives EMA Validation for Marketing Authorization Applications in Europe

NewAmsterdam Pharma Company N.V. has announced that the European Medicines Agency $(EMA)$ has validated the Marketing Authorization Applications $(MAA)$ for their drug obicetrapib. The applications cover both the 10 mg monotherapy and the 10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination, targeting patients with primary hypercholesterolemia, including both heterozygous familial and non-familial forms, as well as mixed dyslipidemia. These submissions, made by NewAmsterdam's partner A. Menarini International Licensing S.A., mark a significant step in the regulatory review process. Menarini is responsible for regulatory communications, commercialization, and local development within Europe, under an exclusive license agreement with NewAmsterdam. The company is entitled to tiered double-digit royalties on net sales in the Menarini Territory and stands to achieve additional financial milestones upon successful regulatory and commercial progress.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. NewAmsterdam Pharma Company NV published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9513723-en) on August 18, 2025, and is solely responsible for the information contained therein.

免責聲明:投資有風險,本文並非投資建議,以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請,作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考,不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證,投資者應自行研究並在投資前尋求專業建議。

熱議股票

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10