Pentixapharm wins FDA clearance to start Phase III PANDA trial of Ga-PentixaFor in primary aldosteronism

  • Pentixapharm received FDA clearance to begin the Phase III PANDA study of [68Ga]Ga-PentixaFor in primary aldosteronism; no trial results have been presented yet.
  • The trial is designed to support use of a non-invasive PET/CT scan to localize aldosterone overproduction, potentially reducing reliance on invasive adrenal vein sampling.
  • The company targets about 270 patients, with study start planned for the second half of the year.
  • US launch is planned for 2030 if development stays on track.
  • Management forecasts annual revenue potential above USD 1 billion several years post-approval, citing a large underdiagnosed hypertension-related market.


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