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Starpharma Holdings Limited (ASX:SPL)

ALERT: Price-sensitive ASX Announcement for SPL
Current share price for SPL : $0.735 0.055 (8.09%)+
Announcement
Release
21 Apr 2026 9:40AM
Price at Release
$0.680
Full Release
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Summary
Starpharma Holdings Limited, an innovative biotechnology company, announced the confirmation from the FDA regarding the clinical pathway for its DEP® HER2 program. The FDA has provided positive feedback on the proposed first-in-human (FIH) phase 1 clinical study design for the dendrimer-based radioligand therapy, targeting advanced HER2-expressing cancers. The FDA acknowledged the significant unmet medical needs in patients who have exhausted available HER2 therapies, and supported Starpharma’s strategy, which could eventually lead to Fast Track designation. Starpharma plans to commence the initial phase 1 study in Europe in H2 CY 2026, involving up to 15 patients, to evaluate safety and pharmacokinetic profiles. The feedback received gives Starpharma confidence in leveraging its dendrimer technology for broader therapeutic applications, especially in radiotherapy.
Key Points
  • FDA confirms path for DEP® HER2 first-in-human study.
  • Study targets unmet needs in advanced HER2-expressing cancers.
  • FIH phase 1 study to begin in Europe in H2 CY 2026.
  • Starpharma's dendrimer platform aims to enhance radiotherapy applications.
  • Positive FDA feedback suggests potential for Fast Track designation.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.