INmune Bio Sets Mid-2026 Timeline for BLA and MAA Filings Amid CEO Transition

INmune Bio has outlined its plans to submit a Biologics License Application (BLA) and Marketing Authorization Application (MAA) for its lead asset, CORDStrom, in mid-2026. The company has also announced the appointment of David J. Moss as Chief Executive Officer, following the retirement of co-founder RJ Tesi. Moss highlighted the strategic shift towards developing CORDStrom for the treatment of autoimmune diseases.

INmune Bio Inc. (NASDAQ: INMB), a biotechnology company specializing in immunomodulatory therapies, has outlined plans to submit a Biologics License Application (BLA) and Marketing Authorization Application (MAA) for its lead asset, CORDStrom™, in mid-2026. The company also announced the appointment of David J. Moss as its new Chief Executive Officer, following the retirement of co-founder RJ Tesi.

Moss emphasized the strategic shift towards developing CORDStrom™ for the treatment of autoimmune diseases, particularly recessive dystrophic epidermolysis bullosa (RDEB). The Mission EB Phase 2 trial, completed at Great Ormond Street Hospital, demonstrated that CORDStrom™ was well-tolerated and showed beneficial effects on multiple endpoints, including the Itch Man Scale, a clinically meaningful measure in RDEB patients [1].

The company expects to file the BLA in the US and the MAA in the UK/EU by mid-2026. With an estimated 4,000 RDEB patients in these regions, INmune Bio sees a potential peak sales opportunity exceeding $1 billion. The appointment of Moss comes as the company seeks to accelerate its clinical development and commercialization efforts, particularly for CORDStrom™.

The new CEO highlighted the importance of strategic partnerships and the company's focus on rare disease pathways for faster market access. Moss also confirmed that the company has made the decision to not pursue treatment-resistant depression at this time for XPro™, shifting focus to more efficient indications. Regarding INKmune™, the company's off-the-shelf NK cell therapeutic candidate, Moss stated that the Phase I/II program is near completion and the data demonstrate that INKmune™ is safe and delivers immunologic benefits, with plans to explore earlier-stage disease trials.

The appointment of Moss and the strategic shift towards CORDStrom™ reflect the company's commitment to advancing its three-platform strategy, which includes XPro™ for Alzheimer's disease, CORDStrom™ for RDEB, and INKmune™ in oncology. Despite the promising clinical data presented across all three platforms, INmune Bio's stock has experienced significant volatility, with shares closing at $2.79 on August 7, 2025, well below analyst targets of $20-30 [2].

Investors will be closely watching upcoming regulatory interactions, particularly the End of Phase 2 meeting for XPro™, which could provide clarity on the path to potential approval for the company's lead asset in Alzheimer's disease. The company's anticipated milestones for 2025-2026 include the End of Phase 2 FDA meeting for XPro™, the BLA/MAA submission for CORDStrom™, and the completion of Phase 2 mCRPC enrollment and reporting of open-label Phase 2 data for INKmune™.

References:
[1] https://www.investing.com/news/company-news/inmune-bio-august-2025-slides-threeplatform-strategy-shows-clinical-progress-93CH-4179058
[2] https://seekingalpha.com/news/4482843-inmune-bio-outlines-cordstrom-bla-and-maa-filings-targeted-for-midminus-2026-as-ceo