INmune Bio Submits Two Regulatory Packages To EMA For Ebstrocel: Application For Orphan Drug Designation And Scientific Advice Package To Streamline Upcoming MAA In Europe
Orphan Drug Designation application and pre-MAA Scientific Advice package submitted for Ebstrocel™ in RDEBFilings support a planned EU MAA in Q1 2027; orphan designation, if granted and maintained through approval, may
INmune Bio asked European health officials to review their medicine Ebstrocel and help them prepare for final approval next year. This is like getting feedback before taking a big test, which usually means the company is organized and serious about selling there.
Last session drawn · prints held ~15 minutes · licensed exchange data
Source: Benzinga · Read the original report at the publisher. Headline and figures shown for context; data may be delayed.
Disclosure: Educational and informational purposes only — not financial advice. We educate, not advise. Market data may be delayed up to 15 minutes unless marked real-time. Past performance is not indicative of future results.