RegulatoryJun 25, 2026, 07:02 AM
INmune Bio's Ebstrocel PIP Approved by UK MHRA for RDEB
AI Summary
INmune Bio announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved the Pediatric Investigation Plan (PIP) for Ebstrocel™ for Recessive Dystrophic Epidermolysis Bullosa (RDEB). This approval is the first required stage toward a Marketing Authorization Application (MAA) submission in the United Kingdom, aligning with the company's 2026 MAA filing timeline and early 2027 US filing for Accelerated Approval. The MHRA's expedited review, completed in under three months, validates the clinical data package and significantly de-risks the regulatory pathway for Ebstrocel™.
Key Highlights
- UK MHRA approved Pediatric Investigation Plan (PIP) for Ebstrocel™ for RDEB.
- Approval accelerates regulatory path for Ebstrocel™ in the United Kingdom.
- PIP is the first required stage for Marketing Authorization Application (MAA) in UK.
- Company maintains 2026 MAA filing timeline for UK and early 2027 for US.
- MHRA completed review in under three months, faster than expected ten-month cycle.
- Approval addresses critical unmet medical need for approximately 300 children with RDEB in UK.
- Represents significant regulatory de-risking for Ebstrocel™ and CORDStrom™ platform.
Price Impact
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