Record mula sa primary source
MateryalIba pa
INmune Bio tumanggap ng pagkakahanay mula sa MHRA para sa 2026 UK MAA ng Ebstrocel sa RDEB
Ang mga nakasulat na minuto ng MHRA mula sa pulong bago ang MAA noong Mayo 12 ay nagpapatunay ng pagkakahanay sa mga pakete ng CMC, non-clinical at clinical, na nagbubukas ng daan para sa 2026 UK Conditional Marketing Authorization Application. Kinilala ng ahensya ang datos ng MissionEB Phase 2 bilang nagpapakita ng klinikal na makabuluhang symptomatic benefit at sinang-ayunan ang pagpoposisyon ng Ebstrocel bilang chronic o intermittent supportive therapy. Isasama ng INmune Bio ang patnubay ng MHRA sa endpoint sa kanilang confirmatory Phase 3 program at plano nilang gamitin ang feedback para sa mga susunod na filing sa EMA at FDA.
Mahahalagang fact
- Na-file
- Hun 23, 2026, 08:05 PM
- Kaganapan
- Iba pa
- Direksyon
- Positibo
- Kumpanya
INMBINmune Bio Inc.- Asset
- Ebstrocel
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
Sipi mula sa source
EX-99.1 2 ea029563501ex99-1.htm PRESS RELEASE DATED JUNE 23, 2026 Exhibit 99.1 INmune Bio Receives MHRA Written Alignment Supporting Planned 2026 UK Conditional Marketing Authorization Application for CORDStrom™ in RDEB ● MHRA minutes from May 12 pre-MAA Scientific Advice meeting confirm agreement across all questions covering CMC, non-clinical and clinical evidence packages ● MHRA pediatric feedback recognizes MissionEB Phase 2 data as demonstrating clinically meaningful symptomatic benefit, particularity pain and pruritis, and states the data could support positioning as chronic or intermittent supportive therapy for RDEB BOCA RATON, Fla, June 23, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a late-stage biotechnology company focused on inflammation and i
Higit pa tungkol sa asset na ito
Materyal
Hun 25, 2026
11:00 AM
INMBINmune Bio Inc.Materyal
Ene 27, 2026
09:00 PM
INMBINmune Bio Inc.