Unicycive: FDA to Review Lead Drug Candidate for Hyperphosphatemia

Dow Jones
2024-11-11
 

By Colin Kellaher

 

Unicycive Therapeutics said the Food and Drug Administration accepted its application seeking approval of its lead drug candidate as a treatment for an electrolyte disorder related to kidney disease.

Unicycive, which is seeking an FDA green light for oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease who are on dialysis, Monday said the agency set a target action date of June 28, 2025 for the application.

The Los Altos, Calif., clinical-stage biotechnology company said oxylanthanum carbonate, if approved, would lower the pill burden in terms of the number and size per dose for patients with hyperphosphatemia, a condition involving too much phosphate in the blood that occurs in nearly all patients with end-stage renal disease.

Unicycive said it was preparing to commercialize and launch the drug in the second half of 2025.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

November 11, 2024 07:31 ET (12:31 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.

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