Exousia Pro is Excited to Announce that it has Received Orphan Drug Designation from the FDA
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.
Exousia Pro (OTCPINK: MAJI) ha annunciato che la FDA ha concesso Designazione di Farmaco Orfano (ODD) per il suo trattamento basato su esosomi per il glioma maligno (glioblastoma multiforme) il 28 ottobre 2025. L'ODD è stata presentata dalla controllata Exousia AI con il dottor Marvin S. Hausman ed è finalizzata ad accelerare la terapia dell'azienda nelle prossime fasi cliniche.
Il comunicato rileva che solo l'11% degli ODD sono assegnati nella fase preclinica e che l'azienda intende collaborare con banchieri d'investimento per monetizzare la designazione mantenendo lo sviluppo. La direzione descrive la tecnologia come esosomi carichi di acidi nucleici combinati con la terapia anticancro standard per GBM.
Exousia Pro (OTCPINK: MAJI) anunció que la FDA concedió Designación de Medicamento Huérfano (ODD) para su tratamiento basado en exosomas para el glioma maligno (glioblastoma multiforme) el 28 de octubre de 2025. La ODD fue presentada por la subsidiaria Exousia AI con el Dr. Marvin S. Hausman y tiene como objetivo llevar la terapia de la empresa a las próximas fases clínicas.
El comunicado señala que solo el 11% de las ODD se otorgan en la etapa preclínica y que la empresa planea trabajar con banqueros de inversión para monetizar la designación mientras continúa el desarrollo. La dirección describe la tecnología como exosomas cargados con ácido nucleico combinados con la terapia anticáncer estándar para GBM.
Exousia Pro (OTCPINK: MAJI)가 2025년 10월 28일 FDA로부터 악성 뇌종양(글리오블라스트종뇨모, GBM) 치료제에 대한 고아약 지정(ODD)를 부여받았다고 발표했다. ODD는 자회사 Exousia AI가 Dr. Marvin S. Hausman과 함께 신청했으며, 회사의 치료제를 다음 임상 단계로 진행시키기 위한 것이다.
발표는 ODD의 11%만이 전임상 단계에서 수여되며, 회사가 지정을 수익화하기 위해 투자은행가와 협력하는 한편 개발을 계속할 계획이라고 한다. 경영진은 이 기술을 뉴클레익산으로 로딩된 엑소좀과 표준 항암 치료를 GBM에 결합한 것으로 설명한다.
Exousia Pro (OTCPINK: MAJI) a annoncé que la FDA a accordé une Designation de médicament orphelin (ODD) pour son traitement à base d'exosomes contre le gliome malin (glioblastome multiforme) le 28 octobre 2025. L'ODD a été déposée par la filiale Exousia AI avec le Dr Marvin S. Hausman et vise à faire progresser la thérapie de l'entreprise vers les prochaines phases cliniques.
Le communiqué indique que seulement 11% des ODD sont attribués à l'étape préclinique et que l'entreprise prévoit de travailler avec des banques d'investissement pour monétiser la désignation tout en poursuivant le développement. La direction décrit la technologie comme des exosomes chargés d'acides nucléiques combinés à une thérapie anticancéreuse standard pour le GBM.
Exousia Pro (OTCPINK: MAJI) kündigte an, dass die FDA am 28. Oktober 2025 eine Orphan Drug Designation (ODD) für die exosomenbasierte Behandlung des malignen Glioms (Glioblastoma multiforme) gewährt hat. Die ODD wurde von der Tochtergesellschaft Exousia AI mit Dr. Marvin S. Hausman beantragt und soll die Therapie des Unternehmens in die nächsten klinischen Phasen vorantreiben.
Die Mitteilung verweist darauf, dass nur 11% der ODDs in der präklinischen Phase verliehen werden und dass das Unternehmen plant, mit Investmentbanken zusammenzuarbeiten, um die Bezeichnung zu monetarisieren, während die Entwicklung fortgesetzt wird. Das Management beschreibt die Technologie als Exosomen, die mit Nukleinsäuren beladen sind und mit der Standardkrebstherapie für GBM kombiniert werden.
Exousia Pro (OTCPINK: MAJI) أعلنت أن إدارة الغذاء والدواء الأمريكية منحت تصنيف دواء يتيم (ODD) لعلاجها المعتمد على الإخراج خارج الخلية (إكسوسومات) لورم الدماغ الخبيث (الورم الدبقي الخبيث المتعدد الأشكال) في 28 أكتوبر 2025. تمت فاعلية الـ ODD من قبل شركة Exousia AI التابعة مع الدكتور مارفين س. هاوسمان، ومن المفترض أن يدفع العلاج للشركة إلى المراحل الإكلينيكية التالية.
وتشير النشرة إلى أن 11% فقط من ODDs تُمنح في المرحلة قبل السريرية وأن الشركة تخطط للعمل مع مصرفيين استثماريين لاستغلال التصميم مع مواصلة التطوير. يصف الإدارة التقنية بأنها إكسوسومات محملة بأحماض نوكليكية ومزدوجة مع العلاج المناعي القياسي لـ GBM.
Exousia Pro (OTCPINK: MAJI) 宣布，美国食品药品监督管理局在2025年10月28日批准其基于外泌体的治疗用于恶性胶质母细胞瘤（GBM）的孤儿药指示（ODD）。ODD 由子公司 Exousia AI 及 Dr. Marvin S. Hausman 提出，旨在推动公司疗法进入下一阶段临床阶段。
公告指出，只有 11% 的 ODD 在临床前阶段授予，公司计划与投资银行合作，在继续开发的同时实现该指示的货币化。管理层将该技术描述为载有核酸的外泌体，与标准的 GBM 抗癌治疗相结合。
- FDA Orphan Drug Designation granted for GBM
- ODD supports advancement into next clinical phases
- Company plans to monetize ODD with investment bankers
- ODD is not an FDA approval and does not prove clinical efficacy
- Program remains largely at a preclinical stage (filed preclinical)
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.
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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?
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Who filed the orphan drug request for Exousia Pro's GBM therapy (MAJI)?
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