Veloxis plans to develop FR104 in order to provide a new therapeutic option in the prophylaxis of organ rejection in patients who have received a solid organ transplant.
Less than three weeks after the green light from the American health authority FDA to launch a clinical study on FR104, Veloxis Pharmaceuticals announces that it has obtained “Fast track” designation for this product. FR104 is an immunosuppressant developed against transplant rejection following kidney transplantation. This status, reserved for therapies with the potential to meet a strong unmet medical need, opens the way to an accelerated regulatory procedure for placing on the market. For the French biotech Ose Immuno, which has entered into a worldwide licensing agreement with Veloxis, this announcement has no financial impact, since it does not trigger a milestone. ” The fast track status could allow to contract the clinical schedule of FR104 as well as that of the associated milestone payments “, nuance the analyst of the cabinet Portzamparc. As part of its partnership with Veloxis, the company has already received 12 million euros, divided between 7 million initial payment and 5 million milestone.
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