1차 출처 기록
중대신청 제출
INmune Bio, 2026년 말 FDA에 CORDStrom BLA 제출 계획
The company states it will submit a BLA to the U.S. FDA for CORDStrom in RDEB toward the end of 2026, following an MAA filing to the UK MHRA planned for mid-summer 2026. The timelines are subject to regulatory feedback and manufacturing readiness. No filing has occurred yet; the letter only outlines the intended submission schedule.
핵심 사실
- 제출
- 2026년 1월 27일 PM 09:00
- 이벤트
- 신청 제출
- 방향
- 중립
- 출처
- SEC 8-K
- 신뢰도
- 출처 확인
출처 발췌
EX-99.1 2 ea027431701ex99-1_inmune.htm PRESS RELEASE DATED JANUARY 27, 2026 Exhibit 99.1 INmune Bio Inc Issues Shareholder Letter Reviewing 2025 Milestones and Outlining 2026 Strategic Initiatives Boca Raton, FL, Jan. 27, 2026 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage inflammation and immunology company, presents the following letter to investors from David Moss, CEO: Dear Fellow Shareholders, As we reflect on 2025, I want to thank you for your continued support of INmune Bio. This past year marked an important period of execution, discipline, and focus as we advanced our mission to develop innovative therapies that address serious neuroinflammatory and immunologic diseases with high unmet needs. 2025 was a pivotal year for our company, highlighted by compe
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중대
2026년 6월 23일
PM 08:05
INMBINmune Bio Inc.