Telix Receives FDA Complete Response Letter for Biologics License Application for Investigational PET Agent, Shares Fall 19%

MT Newswires Live
08/28

Telix Pharmaceuticals (ASX:TLX) received a complete response letter from the US Food and Drug Administration (FDA) for the biologics license application for TLX250-CDx, an investigational positron emission tomography (PET) agent used to diagnose and characterize renal masses as clear cell renal cell carcinoma, according to a Thursday Australian bourse filing.

The letter said that the regulator identified deficiencies relating to the chemistry, manufacturing, and controls package of the agent. The FDA documented notices of deficiency issued to two third-party manufacturing and supply chain partners.

The regulator requested additional data to establish comparability between the drug product used in the ZIRCON phase three clinical trial and the scaled-up manufacturing process intended for commercial use.

The firm said that the submission remediation will begin immediately, and it will request a Type A meeting with the FDA to address the highlighted deficiencies. It plans to continue to provide patient access to TLX250-CDx through an FDA-approved expanded access program, subject to consultation with the regulator.

Its shares fell 19% in recent trading on Thursday, reaching the lowest point in over 52 weeks.

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