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Cynata Therapeutics Limited (ASX:CYP)

ALERT: Price-sensitive ASX Announcement for CYP
Current share price for CYP : $0.012 -0.263 (-95.64%)+
Announcement
Release
3 Jun 2026 8:48AM
Price at Release
$0.275
Full Release
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Summary
Cynata Therapeutics Limited has received a Positive Opinion from the European Medicines Agency's Paediatric Committee (PDCO) for their Paediatric Investigation Plan (PIP) concerning CYP-001, their Cymerus™ iPSC-derived mesenchymal stem cell product designed to treat acute graft versus host disease (aGvHD). CYP-001 has shown promising results in Phase 1 trials, and results from ongoing Phase 2 trials are anticipated soon. The development plan includes a Phase 3 trial in adults and a subsequent Phase 2/3 trial in children. The PDCO's support facilitates the submission of a Marketing Authorisation application for adults while paediatric trials are ongoing. EMA's approval of the PIP is a key milestone toward commercialisation in Europe, where aGvHD is particularly prevalent, with currently no approved cell-based treatments in the region.
Key Points
  • Positive Opinion from EMA's PDCO on CYP-001 Paediatric Investigation Plan
  • CYP-001 is for treatment of acute graft versus host disease (aGvHD)
  • Cynata's Cymerus™ iPSC-derived MSC product, CYP-001, showed success in Phase 1 trials
  • Upcoming results from Phase 2 trial in adults expected in mid-2026
  • Plan for a single Phase 3 trial in adults followed by a Phase 2/3 trial in children
  • PDCO supports timing of paediatric trial with Marketing Authorisation application possible during trial
  • EMA approval of PIP is crucial for commercialisation in the EU
  • aGvHD is more prevalent in Europe than the USA
  • No EMA-approved cell-based therapies currently exist for aGvHD
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.