INmune Bio INMB
INmune Bio (Nasdaq: INMB) is a rare genetic drug developer. Its lead program, CORDStrom, is in Phase 3 for Recessive Dystrophic Epidermolysis Bullosa (RDEB). Its next catalyst on record is CORDStrom: MAA filing in United Kingdom (February 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: CORDStrom — MAA filing in United Kingdom (February 2027). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| CORDStrom | Recessive Dystrophic Epidermolysis Bullosa (RDEB) | cell therapy | Phase 3 |
| XPro1595 | Alzheimer's Disease | protein/peptide | Phase 2 |
| INKmune | Metastatic castrate-resistant prostate cancer (mCRPC) | cell therapy | Phase 2 |
Recent results and decisions
- Oct 29, 2026n/a XPro1595™ received FDA Fast Track designation and successful regulatory alignment from an End-of-Phase 2 meeting, positioning it for an integrated Phase 2b/3 seamless adaptive registrational program.
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.
Filing - Oct 20, 2026submitted INmune Bio submitted final pre-MAA package for Ebstrocel to UK MHRA on October 20, 2026, and plans full MAA submission in early February 2027.
The Company has submitted its final pre-Marketing Authorisation Application (pre-MAA) package to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Ebstrocel™ (CORDStrom™).
Filing - Jan 27, 2026missed Full mITT population (n=200) showed no treatment effect; biomarker-defined subgroup (n=100) showed EMACC effect size 0.27, NPI -0.24, pTau217 -0.18.
While the broader modified intent-to-treat population (n=200) did not show a treatment effect, we observed meaningful and biologically consistent signals in a predefined subpopulation of amyloid-positive early AD patients with two or more biomarkers of inflammation (n=100).
Filing
3 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 rare genetic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.