(BFM Bourse) – The French biotech partner has received orphan drug designation from the American health authority for pegrizeprument, a treatment in preventing organ rejection in patients receiving a heart transplant.
OSE Immunotherapeutics starts this new week in great shape. The Nantes biotechnology company sees its stock soar on Monday, April 27, with a 20% increase around 12:20, after having surged nearly 30% at the beginning of the session.
This stock surge is associated with the announcement by its partner Veloxis Pharmaceuticals. It indicated on Monday that it had obtained orphan drug designation from the Food and Drug Administration (FDA), the American health authority, for its treatment in preventing organ rejection in patients receiving a heart transplant.
An important regulatory milestone
The FDA’s orphan drug designation grants orphan status to drugs and experimental biological products aimed at preventing, diagnosing, or treating rare diseases and medical conditions affecting fewer than 200,000 people in the United States. This law encourages the development of treatments for patients with rare diseases, whose conditions are traditionally under-treated.
This designation from the American health authority concerns pegrizeprument (VEL-101), an innovative monovalent immunomodulatory monoclonal antibody fragment in development, initially discovered and developed by OSE Immunotherapeutics and licensed to Veloxis in 2021 for all transplantation-related indications.
As part of this licensing agreement, Veloxis is responsible for global development, manufacturing, and future commercialization of the product. In return, OSE Immunotherapeutics is entitled to an initial payment of 7 million euros and milestone payments based on predetermined development stages, totaling up to 315 million euros, as well as royalties on sales if the molecule receives regulatory approval for commercialization.
“The important point is that pegrizeprument, initially discovered by OSE and then licensed to Veloxis in 2021 for all transplantation-related indications, continues to advance in a favorable regulatory framework in rare markets with a strong medical need,” appreciate analysts from Allinvest Securities.
They add that the FDA’s decision “strengthens the regulatory credibility of the asset in transplantation,” after an initial orphan drug grant in January 2026 for preventing organ rejection in patients receiving a liver transplant.
“That said, the announcement remains primarily incremental at this stage: an orphan drug grant brings development benefits and potential exclusivity but is not a clinical catalyst in itself,” however, the research office cautions.
Nevertheless, this new regulatory success for OSE Immunotherapeutics reinforces, according to Allinvest Securities, the visibility of the transplantation program without significantly altering the trajectory or dynamics of the collaboration with Veloxis.
A “more streamlined” strategy
Last month, OSE Immunotherapeutics indicated that it had implemented its 2026-2028 plan, unveiled at the end of 2025. The biotech has thus made decisions within its portfolio by pausing or discontinuing certain programs deemed non-priority.
OSE Immunotherapeutics’ new roadmap revolves around its high-potential assets in advanced phases, such as Lusvertikimab (OSE-127), its potential treatment for ulcerative colitis in development with Servier, Tedopi, its vaccine candidate for a type of lung cancer, and in ovarian cancer.
Meanwhile, its partner Boehringer Ingelheim decided to halt the development of BI 770371 in patients with liver cirrhosis due to NASH, following a Phase II exploratory trial showing no efficacy in this indication. The company also paused the development of OSE-230, a monoclonal antibody designed to resolve chronic inflammation, which was part of a partnership with AbbVie.
“The value creation primarily relies on completing Phase III (advanced clinical trial phases, prior to potential commercialization, editor’s note) of Tedopi and the selective redeployment of Lusvertikimab in a partnership logic, in an increasingly favorable environment for oral and subcutaneous administrations,” detailed Allinvest Securities in a previous market comment.
Kepler Chevreux analysts estimated in a note published late March that OSE Immunotherapeutics had begun 2026 with a more streamlined strategy and, in their opinion, clearer than at any other moment in its recent history.
“The company has spent much of the last four years dealing with a common paradox among clinically rich biotechs but resource-limited: a product portfolio large enough to generate a steady flow of news but not concentrated enough to instill in investors the deep conviction that leads to sustainable valuation premiums,” the research office also noted.
To implement this new plan, OSE Immunotherapeutics recently updated its executive team, with the appointment of Thomas Gidoin as Deputy General Manager and Aurore Morello as Chief Scientific Officer.
Kepler Chevreux anticipates the announcement of positive news over the next three years, even as the research office reminds investors that the company faces short-term financing constraints, with cash expected until the beginning of the fourth quarter.
Sabrina Sadgui – ©2026 BFM Bourse
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