INMUNEBIO INC.

INmune Bio reported progress with CORDStrom (marketed as Ebstrocel) and plans an MAA in the UK in Q4 2026 as well as BLA/MAAs in the US and Europe in Q1 2027. Clinical data show strong signals, with around 70% reduction in itch severity and more than 200 administrations without serious adverse events; manufacturing has been validated on a scalable, closed bioreactor system. An open phase III study is planned to start in Q1 2027, while the Alzheimer program XPro is provisionally paused to focus resources on CORDStrom. » Mais em de.investing.com

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. » Mais em 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. » Mais em de.investing.com