Starpharma Wins FDA Backing for DEP HER2 Trial as Partnerships and Product Sales Advance

Starpharma Holdings Limited ( (AU:SPL) ) has provided an update.

Starpharma reported strong operational momentum in the March quarter, highlighted by U.S. FDA alignment on the first-in-human phase 1 trial design for its DEP® HER2 radiotherapeutic, a targeted lutetium-177 dendrimer conjugate for advanced HER2-expressing cancers with significant unmet need. The company has completed European site selection and is advancing trial-enabling activities to start the study in the second half of 2026, while also exploring additional DEP®-based modalities to expand its internal pipeline.

Strategic partnerships progressed in line with development plans, with the Star Navigator program used to engage prospective partners at major industry conferences and new Genentech collaboration data demonstrating DEP®’s ability to improve efficacy and tolerability of SMARCA2-targeting PROTACs in non-small cell lung cancer models. Starpharma also reported growing revenue contribution from Viraleze™ and continued global interest in VivaGel® BV, alongside active investor outreach to highlight its clinically validated DEP® platform and multiple routes to long-term value creation, supported by a cash balance of $14.1 million at 31 March 2026.

More about Starpharma Holdings Limited

Starpharma Holdings Limited is an Australian biotechnology company specialising in dendrimer-based drug delivery and novel therapeutics, with a core focus on oncology and infectious diseases. Its key platforms include the DEP® dendrimer drug conjugate technology and marketed products Viraleze™ and VivaGel® BV, with a strategic emphasis on radiopharmaceuticals and global partnering to expand clinical and commercial reach.

Average Trading Volume: 1,827,258

Technical Sentiment Signal: Buy

Current Market Cap: A$303.1M

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