Exousia Pro is Excited to Announce that it has Received Orphan Drug Designation from the FDA
Rhea-AI Summary
Exousia Pro (OTCPINK: MAJI) announced that the FDA granted Orphan Drug Designation (ODD) for its exosome-based treatment for malignant glioma (Glioblastoma multiforme) on October 28, 2025. The ODD was filed by subsidiary Exousia AI with Dr. Marvin S. Hausman and is intended to advance the company's therapy into the next clinical phases.
The release notes that only 11% of ODDs are awarded at the preclinical stage and that the company plans to work with investment bankers to monetize the designation while continuing development. Management describes the technology as exosomes loaded with nucleic acids combined with standard anticancer therapy for GBM.
Positive
- FDA Orphan Drug Designation granted for GBM
- ODD supports advancement into next clinical phases
- Company plans to monetize ODD with investment bankers
Negative
- ODD is not an FDA approval and does not prove clinical efficacy
- Program remains largely at a preclinical stage (filed preclinical)
News Market Reaction
On the day this news was published, MAJI gained 9.09%, reflecting a notable positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Exousia Pro is in a unique position, as only
ORLANDO, FLORIDA / ACCESS Newswire / October 28, 2025 / Exousia Pro, Inc. (formerly Marijuana, Inc.) (OTCPINK:MAJI), a clinical-stage biotech company using exosomes in the treatment of cancer and other maladies, is pleased to announce it has received Orphan Drug Designation from the FDA, for malignant Glioma, aka Glioblastoma multiforme (GBM).
Exousia Pro's subsidiary, Exousia AI, along with Dr. Marvin S. Hausman, filed for Orphan Drug Designation last year for its exosome-based GBM treatment. The ODD approved by the FDA opens a world of opportunities for advancing the company's cancer therapy as it moves into the next clinical phases.
"GBM is the most common and highly malignant central nervous system (CNS) tumor that currently lacks adequate treatment," stated Marvin S. Hausman, MD, Chairman of the Scientific Advisory Board (SAB). "Our breakthrough exosomal technology has the ability to deliver a wide range of therapeutics, including genetic material, into cells afflicted with cancer, such as GBM. The therapeutic technology presented in this orphan drug application is a method for using exosomes loaded with desired nucleic acids, in the effective treatment of GBM when combined with currently available standard anticancer therapy."
To receive Orphan Drug Designation, a company, like Exousia AI, must submit a request to the FDA with a scientific rationale demonstrating a medically plausible basis for expecting the drug to be effective in treating the rare disease. Preclinical or clinical data often support this rationale. The FDA reviews these requests and, if the criteria are met, grants the orphan drug designation.
"The Company is very excited to have been granted this designation," stated Matthew Dwyer, President of Exousia Pro. "It is hard for us to quantify the value of ODD as it is likely in the 10's of millions of dollars. We will soon begin working with investment bankers to monetize the ODD as we advance our therapy. GBM is a terrible disease and pretty much a death sentence for most. We believe our combination therapy has the potential to be disease-modifying and could make a huge difference for this patient population."
About Exousia Pro, Inc.
Exousia Pro, Inc. (EXO), a leader in exosome-based biotechnology, develops and manufactures mammalian and plant-derived exosomes using proprietary technologies for nucleic acid loading and targeted delivery to tissues and cells. EXO's breakthrough platform enables the custom production of exosomes with enhanced genetic functionality, capable of selectively targeting specific cells to address diseases with significant unmet medical needs. These engineered exosomes have demonstrated the potential to target cancer stem cells, the primary drivers of recurrence and metastasis in various cancers, including Glioblastoma and Pancreatic cancer, thereby improving patient responsiveness to anticancer therapies. The same platform technology also holds promise for treating a broad spectrum of viral infections.
For more information, please visit: www.exousiapro.com
SAFE HARBOR
Forward-looking statements in this release are made under the "safe harbor" provision of the Private Securities Litigation Reform Act of 1995. Ludwig Enterprises Inc.'s forward-looking statements do not guarantee future performance. This news release includes forward-looking statements concerning the future level of business for the parties. These statements are necessarily subject to risk and uncertainty. Actual results could differ materially from those projected in these forward-looking statements due to certain risk factors that could cause results to differ materially from estimated results. Management cautions that all statements as to future results of operations are necessarily subject to risks, uncertainties, and events that may be beyond the control of Ludwig Enterprises, Inc., and no assurance can be given that such results will be achieved. Potential risks and uncertainties include, but are not limited to, the ability to procure, appropriately price, retain, and complete projects and changes in products and competition.
CONTACT:
Marijuana, Inc.
www.Exousiapro.com
Twitter: @Exousia_Pro
Investor Relations
ir@exousiapro.com
SOURCE: Exousia Pro, Inc.
View the original press release on ACCESS Newswire
FAQ
What did Exousia Pro (MAJI) announce on October 28, 2025 about GBM?
Does the FDA Orphan Drug Designation for MAJI mean the GBM treatment is approved?
What stage is Exousia Pro's GBM program after the ODD granted to MAJI?
How might the Orphan Drug Designation affect MAJI's finances or valuation?
Who filed the orphan drug request for Exousia Pro's GBM therapy (MAJI)?
What therapeutic approach does MAJI's GBM candidate use?
