Bioceltix SA
GGPW:BCX62.50
PLN
-2.30
(-3.55%)
Bioceltix SA
GPW:BCX
(Warsaw Stock Exchange)
Recent
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62.50
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yld
- -
ROIC.AI
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- Business
- Bioceltix S.A. (BCX.WA) develops stem cell-based biopharmaceuticals for veterinary applications, focusing on mesenchymal stem cell (MSC) therapies for companion animals including dogs and horses; its core products comprise BCX-CM-J, a biological drug for treating degenerative joint lesions and osteoarthritis in dogs via intra-articular injections; BCX-CM-AD, a candidate for atopic dermatitis in dogs using allogeneic stem cells to reduce inflammation and skin lesions; and BCX-EM, a therapy for arthritis in horses administered through parenteral injections. The company operates from its cGMP-certified facility in Wroclaw, Poland, where it was founded in 2018, targeting high-demand markets in Europe for innovative treatments addressing unmet needs in animal health such as pain management and autoimmune conditions beyond symptomatic care. Bioceltix employs approximately 36 staff and pursues geographic expansion through regulatory approvals and partnerships in the EU veterinary sector. In recent developments, the company submitted a marketing authorization dossier to the European Medicines Agency for BCX-CM-J on May 17, 2024, with evaluation underway and potential approval expected in 2025; it completed a secondary public offering in June 2024 raising PLN 43 million net to fund manufacturing upgrades including a new stem cell facility set for launch in 2025-2026; pivotal studies for BCX-CM-AD and BCX-EM advanced with results anticipated in late 2024, alongside interim analysis confirming efficacy in canine atopic dermatitis; and Bioceltix secured a PLN 10.6 million PARP grant for BCX-CM-AD while negotiating distribution partnerships with large animal health firms for commercialization starting 2025.