INMUNEBIO INC.

INmune Bio has filed with the EMA for orphan-drug designation and submitted materials for scientific advice ahead of an EU marketing-authorization application for Ebstrocel. Ebstrocel is a pooled, allogeneic mesenchymal stromal cell therapy derived from umbilical cord for the treatment of recessive dystrophic epidermolysis bullosa. The filings are intended to support an EU MAA planned for Q1 2027; parallel plans include a UK application in Q4 2026 and a US BLA in Q1 2027. If orphan designation is granted, regulatory incentives and up to ten years of market exclusivity could follow in the EU; Ebstrocel already has orphan status in the US. » Más en de.investing.com

INmune Bio has received government research and development grants totaling about $4.6 million (approximately $4.2 million from Australia and about $0.4 million from the UK). The non-dilutive funds exceed the net cash used for operating activities in the second quarter and extend the company’s cash runway. The grants relate to eligible expenditures for clinical development, manufacturing and regulatory activities. INmune Bio is advancing its CORDStrom and XPro1595 platforms; regulatory filings for CORDStrom are planned in the UK (2026), the EU (2027) and the US, while XPro1595 has received FDA fast-track status and is intended for a phase 2b/3 program in early Alzheimer’s disease. » Más en de.investing.com

INmune Bio released imaging data from its phase 2 study of XPro/XPro1595 in early‑stage Alzheimer’s that showed a significant improvement in white‑matter myelin integrity after 24 weeks (p < 0.01). Stronger effects were observed in patients selected using the company’s proprietary biomarker enrichment. The analysis includes Chi‑Separation and Cortical Disarray Measurement, two advanced MRI techniques, and supports the idea that XPro shows relevant biological effects early. XPro1595 has FDA Fast Track status; INmune Bio is advancing a registrational phase 2b/3 program and has a market capitalization of about $45.7 million with analyst targets between $4 and $9. » Más en de.investing.com