Drug Profile

Lenzumestrocel - Corestemchemon

Alternative Names: Autologous BM-MSC - Corestemchemon; HYNR-CS; NEURONATA-R

Latest Information Update: 10 Jun 2025

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At a glance

Originator CORESTEM
Developer Corestemchemon
Class Mesenchymal stem cell therapies; Neuroprotectants
Mechanism of Action Cell replacements

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Amyotrophic lateral sclerosis
New Molecular Entity No
Available For Licensing Yes - Amyotrophic lateral sclerosis

Highest Development Phases

Marketed Amyotrophic lateral sclerosis

Most Recent Events

29 May 2025 CORESTEM anticipates accelerated regulatory approval by mid-2026 in the US
29 May 2025 CORESTEM plans to request a Pre-BLA or Type C meeting with the US FDA in Q3 2025
29 May 2025 CORESTEM plans to submit a biologics license application to the US FDA by Q4 2025

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