Companies
Orchard Therapeutics
OTL-200/Libmeldy EMA-approved for MLD; OTL-203 (MPS-I Hurler) completed registrational enrolment 1 year ahead of schedule; OTL-201 (MPS-IIIA) awarded Innovation Passport (UK ILAP) April 2026.
- Country
- United Kingdom
EMA approved (MLD)
Coverage
| CN | EU | US | |
|---|---|---|---|
| regenerative-personalized | ✓ | ✓ | ✓ |
Regulatorsfdaemanmpa
Verifiable facts
| Fact | Value | Source |
|---|---|---|
| Regulatory approval | Libmeldy/OTL-200 is approved by the European Commission, UK MHRA, Swissmedic, and U.S. FDA (as Lenmeldy) | ir.orchard-tx.com · orchard-tx.eu · orchard-tx.com |
| Regulatory approval | OTL-203 has received EMA PRIME designation and FDA RPD designation | ir.orchard-tx.com |
| Revenue | $19.8M (2023) | globaldata.com |
| Headcount | 163 employees (2023) | globaldata.com |
| Headquarters | London, United Kingdom | ir.orchard-tx.com · globaldata.com |
Independent sources: globaldata.com · ir.orchard-tx.com · orchard-tx.com · orchard-tx.eu
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| Personalized & regenerative medicine | regenerative-personalized | Medium | → |
Compiled by BIOECON from primary sources.
Compliance
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