Sernova Biotherapeutics Receives FDA Orphan Drug Designation for Autologous Islet Transplantation for Prevention of Diabetes Due to Total Pancreatectomy
Rhea-AI Summary
Sernova Biotherapeutics (OTC:SEOVF) received FDA Orphan Drug Designation for autologous islet transplantation to prevent diabetes following total pancreatectomy. The approach uses Sernova’s Cell Pouch Bio-hybrid Organ to support engraftment and long-term function of a patient’s own insulin-producing islet cells.
The designation, for a rare condition affecting fewer than 200,000 people in the US, provides potential seven years of market exclusivity upon approval, tax credits for qualified clinical testing, and possible FDA user-fee waivers. Sernova is preparing a clinical trial and plans to advance both type 1 and type 3c diabetes programs.
Positive
- FDA Orphan Drug Designation for autologous islet transplantation program
- Potential seven years of US market exclusivity upon regulatory approval
- Access to tax credits for qualified clinical testing activities
- Potential waiver of certain FDA user fees if criteria are met
- Pipeline expansion into prevention of type 3c diabetes after pancreatectomy
Negative
- None.
News Market Reaction – SEOVF
In the Jun 17 session, SEOVF gained 23.22%, reflecting a significant positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
AI-generated analysis. How Rhea-AI works. Not financial advice.
TORONTO and BOSTON, June 17, 2026 (GLOBE NEWSWIRE) -- Sernova Biotherapeutics Inc. (“Sernova” or the “Company”) (TSX: SVA) (OTC: SEOVF) (FSE/XETRA: PSHO), a leading regenerative medicine company focused on developing its Cell Pouch Bio-hybrid Organ as a functional cure for type 1 diabetes, today announced that the U.S. Food and Drug Administration (“FDA”) has granted orphan drug designation for autologous islet transplantation (“AIT”) for the prevention of diabetes due to total pancreatectomy.
Sernova’s proprietary Cell Pouch Bio-hybrid Organ is designed to support the engraftment and long-term function of transplanted therapeutic cells. Chronic Pancreatitis causes debilitating pain and can lead to a total pancreatectomy, resulting in the patient developing type 3c diabetes (T3cD) that is treated in the same way as type 1 diabetes with the same long-term co-morbidities. Sernova is preparing to initiate a clinical trial with autologous islet transplantation that involves isolating the patient’s own insulin-producing islet cells from the removed pancreas, placing them in Sernova’s Cell Pouch and transplanting them back into the patient, negating the need for immune suppression. The goal is preservation of insulin production and prevention of post-surgical diabetes and its associated complex management and co-morbidities.
“Patients who require total pancreatectomy face a life-changing outcome: the immediate loss of pancreatic endocrine function and the risk of complex, insulin-dependent diabetes,” said Melena Bellin, MD, Co-Director of the Total Pancreatectomy and Islet Autotransplant Program at the University of Minnesota and a member of Sernova’s Clinical Advisory Board. “Autologous islet transplantation in Sernova’s Cell Pouch has the potential to preserve a patient’s own insulin-producing cells following pancreatic surgery, without the use of immune suppressing therapies.”
Subject to successful review of detailed applications, Orphan Drug Designation is granted by the FDA to support the development of drugs and biologics, intended to treat, diagnose, or prevent rare diseases or conditions affecting fewer than 200,000 people in the United States. The designation provides Sernova the potential for seven years of market exclusivity in the United States upon regulatory approval, plus other development incentives, including tax credits for qualified clinical testing, waiver of certain FDA user fees, if applicable criteria are met.
“Receiving Orphan Drug Designation from the FDA is an important milestone for Sernova,” said Jonathan Rigby, Chief Executive Officer of Sernova. “Our primary focus remains advancing a functional cure for type 1 diabetes. At the same time, this designation provides Sernova a potential exclusive lead position in preventing type 3c diabetes. T3cD is a natural extension of our primary focus on T1D and we are planning to advance both of these programs in the coming months.”
ABOUT T3c Diabetes
Type 3c diabetes, also known as pancreatogenic diabetes, occurs when damage to the pancreas impairs its ability to produce insulin and regulate blood glucose. This form of diabetes can result from conditions such as chronic pancreatitis, cystic fibrosis, pancreatic cancer, or other diseases affecting pancreatic function. Surgical removal of all or part of the pancreas, including total pancreatectomy performed to treat serious pancreatic conditions, can also result in Type 3c diabetes due to the loss of insulin-producing pancreatic tissue.
ABOUT SERNOVA BIOTHERAPEUTICS
Sernova Biotherapeutics is a clinical-stage company developing regenerative medicine therapeutics combining its Cell Pouch with human donor cells or stem-cell derived islet-like clusters in collaboration with Evotec to create bio-hybrid organs to treat T1D. A Bio-hybrid Organ is comprised of non-biomaterials, such as the Cell Pouch, integrated with living tissues and blood vessels to provide oxygen and nutrients to contained cells to restore or enhance the function of a compromised or explanted organ.
FOR FURTHER INFORMATION PLEASE CONTACT:
David Burke
VP, Investor Relations
(917) 751-5713
Email: David.Burke@sernova.com
Website: https://sernova.com/
Gloria Gasaatura
LifeSci Communications
ggasaatura@lifescicomms.com
The TSX has not reviewed this news release and does not accept responsibility for the accuracy or adequacy of this news release.
FORWARD-LOOKING INFORMATION
This press release contains forward-looking statements within the meaning of applicable Canadian securities laws. Forward-looking statements in this press release include our expectation of advancing both our T1D and T3C diabetes programs in the coming months. With respect to the forward-looking statements contained in this press release, Sernova has made numerous assumptions regarding, among other things: the company’s ability to secure additional financing on reasonable terms, or at all; and the ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch, including the timing and results of those trials. A more complete discussion of the risks and uncertainties facing Sernova appears in Sernova’s Annual Information Form for the year ended October 31, 2025, filed with Canadian securities authorities and available at www.sedarplus.ca, as updated by Sernova’s continuous disclosure filings, which are available at www.sedarplus.ca. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Sernova disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.
Orphan drug designation does not constitute FDA approval and does not guarantee that the product candidate will receive marketing approval or orphan drug exclusivity.
