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Patrys Limited (ASX:PAB)

ALERT: Price-sensitive ASX Announcement for PAB
Current share price for PAB : $0.043 0.009 (26.47%)+
Announcement
Release
11 Mar 2026 8:23AM
Price at Release
$0.034
Full Release
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Summary
Patrys Limited has initiated key manufacturing and regulatory activities to advance RLS-2201, an injectable formulation of Quetiapine for treating delirium, towards clinical trials. The engineering batch manufacturing has started at BioCina, which will support process reproducibility, stability testing, and early material for clinical trials. US regulatory engagement with Facet Life Sciences has commenced to support the FDA investigational new drug application process. The company is also in discussions with Contract Research Organisations for Phase 0 clinical trial planning. These steps aim to address a significant unmet medical need for rapid-delirium treatment, with clinical trials expected to begin in the second half of 2026.
Key Points
  • Engineering batch manufacturing initiated at BioCina.
  • US regulatory advisor engagement begun ahead of FDA pre-IND submission.
  • CRO selection process for Phase 0 trial is underway.
  • First-in-human Phase 0 clinical trial planned for H2 2026.
  • RLS-2201 targets a significant unmet need in delirium treatment.
  • Engagement with Facet Life Sciences for regulatory strategy.
  • Plans to leverage existing Quetiapine data for RLS-2201 development.
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.