MHRA Approves INmune Bio's CORDStrom™ Pediatric Plan Ahead of Schedule, Accelerating UK Market Path
INMB sits 37% above its 52-week low of $1.09.
Summary
INmune Bio received MHRA approval for its Pediatric Investigation Plan (PIP) for Ebstrocel™ (CORDStrom™) in the UK, a critical step towards market authorization for Recessive Dystrophic Epidermolysis Bullosa (RDEB). This approval was granted in under three months, significantly faster than anticipated, and provides a clear roadmap for a planned 2026 Marketing Authorization Application. This regulatory de-risking event is highly positive for the small-cap biotech, especially given its recent "going concern" warning. The company aims for a UK MAA filing in 2026 and a US Accelerated Approval filing in early 2027.
At the time of this announcement, INMB was trading at $1.49 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $35.9M. The 52-week trading range was $1.09 to $11.64. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.