INmune Bio Inc. Achieves MHRA Approval of PIP for CORDStrom™
Rhea-AI Summary
INmune Bio (NASDAQ: INMB) received UK MHRA approval of the Pediatric Investigation Plan (PIP) for Ebstrocel, part of the CORDStrom platform, in Recessive Dystrophic Epidermolysis Bullosa (RDEB). This is the first required step toward a 2026 UK Marketing Authorization Application and an early 2027 US Accelerated Approval filing.
The MHRA completed review in under three months, raised no objections to the clinical data or claims, and aligned with the company’s CMC, non-clinical, clinical and post-marketing trial strategy, which INmune Bio views as significantly reducing regulatory uncertainty.
Positive
- MHRA approval of PIP for Ebstrocel in RDEB in the UK
- PIP review completed in under three months vs expected ten
- MHRA raised no objections to clinical data or claims submitted
- Regulatory strategy aligned for planned 2026 UK Marketing Authorization Application
- PIP approval described as de-risking for the broader CORDStrom platform
Negative
- Ebstrocel still requires Marketing Authorization and US approval before potential commercialization
News Market Reaction – INMB
In the Jun 25 session, INMB gained 10.37%, reflecting a significant positive market reaction. Argus tracked a peak move of +13.3% during that session. Argus tracked a trough of -20.7% from its starting point during tracking. Our momentum scanner triggered 12 alerts that day, indicating notable trading interest and price volatility. Trading volume was exceptionally heavy at 10.7x the daily average, suggesting very strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 23 | MHRA alignment | Positive | -0.7% | MHRA written alignment supporting 2026 UK conditional MAA for CORDStrom in RDEB. |
| Jun 02 | Alzheimer’s biomarker data | Positive | +2.2% | Statistically significant white matter MRI biomarker effect in Phase 2 MINDFuL trial. |
| May 15 | Alzheimer’s results paper | Positive | -7.7% | Publication of Phase 2 MINDFuL XPro results in NPJ Dementia with supportive signals. |
| May 14 | FDA Fast Track | Positive | +15.1% | FDA Fast Track designation for XPro1595 in early Alzheimer’s disease. |
| May 07 | Q1 2026 earnings | Neutral | +0.0% | Quarterly results and business update with no immediate share price reaction. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
INMB often shows sharp moves on major regulatory or Alzheimer’s milestones, but can also sell off on otherwise positive clinical updates.
Key Terms
pediatric investigation plan regulatory
marketing authorization application regulatory
accelerated approval regulatory
conditional marketing authorization regulatory
cmc technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Approval of pediatric strategy validates clinical data package and accelerates the regulatory path for CORDStrom™ in the United Kingdom
BOCA RATON, Fla, June 25, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved the Pediatric Investigation Plan (PIP) for Ebstrocel™ for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB).
The approval of the PIP is the first required stage toward a Marketing Authorization Application (MAA) submission in the United Kingdom. This regulatory milestone remains strictly aligned with the Company’s established timetable for an MAA filing in 2026 and a US filing for Accelerated Approval in early 2027.
"We submitted the PIP for Ebstrocel expecting a ten-month review cycle, but requested an accelerated review based on the critical unmet need in RDEB," said Dr. Mark Lowdell, Chief Scientific Officer of INmune Bio. "The MHRA’s turnaround in under three months represents a clear endorsement of the clinical data package. Their constructive advice on minor adjustments to the phase 3 open-label trial protocol has already been integrated. This allows us to maintain our twin-track regulatory strategy: filing for conditional marketing authorization this year to enable early market access, while running the open-label registration trial in 2027 to satisfy post-marketing commitments for full marketing authorization."
In the UK, EU, and U.S., all medicinal products seeking marketing approval must include an agreed-upon plan for pediatric delivery. The Ebstrocel™ PIP submission establishes the scientific justification for treating children with RDEB, characterized not merely as a skin condition but as a devastating systemic disease. The submission highlighted Ebstrocel’s potential to address the most debilitating symptoms reported by the patient community, specifically chronic wounds, intractable itch, and severe pain, which are the primary drivers of poor quality of life. With approximately 300 children affected by RDEB in the United Kingdom, part of a broader epidermolysis bullosa (EB) community of at least 5,000 individuals supported by DEBRA UK, this approval addresses a critical unmet medical need in a well-defined patient population facing substantial care burdens. The MHRA raised no objections to the clinical data or the claims presented in the submission.
"Securing PIP approval ahead of schedule, together with the MHRA's written alignment across our CMC, non-clinical and clinical strategy, represents a significant regulatory de-risking milestone for Ebstrocel™ and the broader CORDStrom™ platform," said David Moss, CEO of INmune Bio. "Importantly, the MHRA has now reviewed and provided guidance across the key elements required for our planned 2026 Marketing Authorization Application, substantially reducing regulatory uncertainty as we move toward submission. The accepted meeting minutes from our face-to-face Scientific Advice meeting provide a clear roadmap for Conditional Marketing Authorization and establishes alignment on the evidence package, manufacturing transition strategy, and confirmatory trial design needed to support review. With these milestones achieved, we believe Ebstrocel is now positioned on a well-defined path to potential approval, bringing us closer to delivering the first systemic therapy designed to address the underlying disease burden of RDEB while creating a significant value inflection opportunity for shareholders as we move from late-stage development toward potential commercialization."
The Company is now focused on its final preparations for the MAA submission and completing the final commercial manufacturing steps necessary for Ebstrocel™ authorization.
About CORDStrom™
CORDStrom™ is a patent-pending cell medicine platform comprising aseptic, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) in suspension for injection or infusion. The CORDStrom™ platform leverages, among other things, proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled hucMSCs as medicines to treat complex inflammatory and autoimmune diseases. CORDStrom™ products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP manufactured, potent cellular medicines that can be produced affordably and with repeatable specification. Pooling allows tuning of different CORDStrom™ products with different effector functions dependent upon selected donor characteristics. The platform enables creation of indication-specific products, which can be tuned for optimization of anti-inflammatory, immunomodulatory, wound healing, and other characteristics. The first of these is Ebstrocel™.
About INmune Bio Inc.
INmune Bio Inc. is a publicly traded (NASDAQ: INMB), late-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. Moving beyond early-stage exploration, the Company’s clinical-development strategy centers on advanced precision medicine, matching drug mechanisms directly to patient biology to optimize clinical outcomes.
INmune Bio is actively advancing two late-stage product platforms toward registrational milestones:
1. CORDStrom™: A proprietary, pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cell platform engineered to address the historical clinical challenges of donor variability and manufacturing inconsistency. Following successful clinical readouts in RDEB, the platform is transitioning to regulatory filing phases, with an MAA planned for the UK MHRA and EU EMA in 2026, alongside a planned U.S. Biologics License Application (BLA) submission.
2. XPro1595™: A Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform that selectively neutralizes soluble TNF (sTNF) to eliminate neuroinflammation without compromising protective immune function. Backed by recently granted FDA Fast Track designation and successful regulatory alignment from an End-of-Phase 2 meeting, XPro1595™ is positioned for an integrated Phase 2b/3 seamless adaptive registrational program in neuroinflammation-enriched early Alzheimer’s disease.
To learn more about INmune Bio’s pipeline and its approach to harnessing the innate immune system, please visit www.inmunebio.com.
Forward Looking Statements
Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, including trial results, timing of key milestones, future plans or expectations, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to several risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements because of these risks and uncertainties. CORDStrom™, XPro1595™ (XPro™, pegipanermin), and INKmune™ have either finished clinical trials, are still in clinical trials or are preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA), the UK MHRA or any regulatory body and there cannot be any assurance that they will be approved by the FDA, the UK MHRA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date of this release.
INmune Bio Contacts:
David Moss
Chief Executive Officer
(561) 710-0512
info@inmunebio.com
Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com
