Companies
Cellenkos
received FDA clearance to initiate a Phase 2 clinical trial of CK0801, an allogeneic cord-blood-derived Treg, for aplastic anaemia, extending Treg therapy beyond oncology into autoimmune haematology.
- Country
- United States
Cord-blood Treg (CK0801)
Coverage
| CN | EU | US | |
|---|---|---|---|
| therapeutics-platforms | ✓ | ✓ | ✓ |
Regulatorsfdaemanmpa
Verifiable facts
| Fact | Value | Source |
|---|---|---|
| Funding | $15 million in total funding from a Series A round concluded on November 4, 2021 | cellenkosinc.com |
| Production site | Cellenkos Manufacturing Facility (CMF) in Houston, TX | cellenkosinc.com |
| Regulatory approval | FDA clearance to initiate Phase 2 clinical trial of CK0801 for aplastic anemia received April 27, 2026 | novapharmanews.com · prnewswire.com |
| Regulatory approval | FDA Orphan Drug Designation for CK0801 for aplastic anemia granted as of April 14, 2025 | synapse.patsnap.com |
| Revenue | Estimated annual revenue ranges from $1.28 million to $50 million depending on the source reporting, with one specific estimate of $6 million for 2025 medium confidence | prospeo.io · adapt.io |
Independent sources: adapt.io · novapharmanews.com · prnewswire.com · prospeo.io · synapse.patsnap.com
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| Stem cell therapy for autoimmune disease | therapeutics-platforms | Medium | → |
Compiled by BIOECON from primary sources.
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