Investors
Capturing Opportunity in a Market Growing at 23% Annually
$25–30B
CAGR 23.0%
$100–250M
Early Deployment
2 of 2
FDA ODD · EMA COMP positive opinion
Nasal Spray to Tumor Targeting
Market Opportunity
Investment highlights
Regulatory Progress
FDA Orphan Drug Designation positive EMA COMP opinion supporting the lead malignant glioma program.
Expanded Access Readiness
Development of a framework to evaluate physician-initiated Expanded Access requests, subject to regulatory authorization and product availability.
Two revenue layers
Therapeutic development alongside CMO/CDMO services for exosome-based manufacturing.
Latest News
Regulatory
FDA grants Orphan Drug Designation for malignant glioma
The U.S. Food and Drug Administration has granted Orphan Drug Designation for shRNA targeting NANOG mRNA for the treatment of malignant glioma, including Glioblastoma Multiforme. Exousia Bio is developing an exosome-based delivery approach for this therapeutic strategy.
Europe
EMA COMP issues a positive opinion
A positive opinion from the Committee for Orphan Medicinal Products extends the regulatory frame to the EU.
Access
A framework for physician-initiated expanded access
Exousia Bio is developing a review pathway for compassionate use requests in malignant glioma.