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2024-05-30

Veloxis Pharmaceuticals Selected to Present at the 2024 American Transplant Congress in Philadelphia

Veloxis Pharmaceuticals, Inc. (Veloxis), a fully integrated specialty pharmaceutical company, is pleased to announce the presentation of VEL-101 research at the 2024 American Transplant Congress (ATC).

2024-03-28

Veloxis Pharmaceuticals Chief Scientific Officer to Receive National Kidney Foundation’s Market Innovation Award

Ulf Meier-Kriesche, MD, FAST, Chief Scientific Officer of Veloxis Pharmaceuticals, will receive the Market Innovation Award at the National Kidney Foundation’s 1st Annual North Carolina Honors Reception.

2023-04-18

Veloxis Pharmaceuticals Partners with Donate Life NC on Gift of Life Gala

Veloxis Pharmaceuticals, a fully integrated specialty pharmaceutical company, is pleased to announce its support of Donate Life North Carolina as the premier sponsor of the 2023 Gift of Life Gala: heART of the Matter on Thursday, April 20th at the Prestonwood Country Club in Cary, N.C.

2022-10-17

Veloxis Pharmaceuticals and Lyfebulb Announce Winners of the 2022 Innovation Challenge in Organ Transplantation

Veloxis Pharmaceuticals, a fully integrated specialty pharmaceutical company, and Lyfebulb, a patient-empowerment platform that connects patients with industry experts to support user-driven innovation, are pleased to announce that Isabel Portero, M.D., Ph.D., founder and CEO at Biohope Scientific Solutions, and Chet Bennett, founder at the C. Alan Foundation, have been selected as the winners of the 2022 Lyfebulb – Veloxis Innovation Challenge.

2022-10-14

C-Path's Transplant Therapeutics Consortium receives EMA Draft Qualification Opinion for the iBox Scoring System

Critical Path Institute (C-Path) announced October 13, 2022 that its Transplant Therapeutic Consortium (TTC), of which Veloxis Pharmaceuticals is a member, received a draft qualification opinion for the iBox Scoring System through the European Medicines Agency's (EMA) qualification of novel methodologies for drug development. This significant qualification means that the iBox Scoring System, which supports the evaluation of novel immunosuppressive therapy (IST) applications with EMA, will soon be available to be used as a secondary efficacy endpoint in kidney transplant clinical trials.

2022-09-19

Lyfebulb and Veloxis Pharmaceuticals Announce Finalists for 2022 Innovation Challenge in Organ Transplantation

New York and North Carolina, September 19, 2022 — Lyfebulb, a patient-empowerment platform that connects patients with industry experts to support user-driven innovation, and Veloxis Pharmaceuticals, a fully integrated specialty pharmaceutical company, are pleased to announce 10 finalists for the 2022 “Transforming Organ Transplantation Through Innovation” Challenge.

2022-07-26

Lyfebulb and Veloxis Pharmaceuticals Seek Applicants for the Global 2022 Innovation Challenge in Organ Transplantation

New York and North Carolina, July 26, 2022 — Lyfebulb, a patient-empowerment platform that connects patients with industry experts to support user-driven innovation, and Veloxis Pharmaceuticals, an Asahi Kasei, fully integrated specialty pharmaceutical company, invite entrepreneurs to apply to their “Transforming Organ Transplantation Through Innovation” Challenge.

2022-06-28

Veloxis Pharmaceuticals Announces Dosing of the First Patient by partner Xenikos in the Global Phase 3 Study Evaluating T-Guard®

Cary, North Carolina, United States – June 28, 2022 – Veloxis Pharmaceuticals, an Ashai Kasei company, today announced dosing of the first patient in a global pivotal Phase 3 clinical study [NCT04934670] designed to evaluate T-Guard® versus ruxolitinib for the treatment of patients with Grade III or IV steroid-refractory acute graft-versus-host disease (SR-aGVHD) following allogeneic hematopoietic stem cell transplant (allo-HSCT). T-Guard is currently being developed by Xenikos B.V., a privately-held biotechnology company that develops innovative immunotherapies for treating patients with severe immune disease and post-transplant rejection.

2022-05-18

Veloxis Pharmaceuticals Announces Dosing of the First Participant in a Phase I Study of VEL-101

CARY, N.C., U.S.A. (May 18, 2022) – Veloxis Pharmaceuticals, Inc., an Asahi Kasei company, today announced that the first participant has been dosed in a Phase 1 Study of VEL-101 [NCT05238493]. VEL-101 is a novel investigational maintenance immunosuppressive agent being developed for prevention of acute rejection in kidney transplant recipients.

2022-03-28

Veloxis Pharmaceuticals, Inc. Initiates Phase 1 Study of ART-123 in the U.S. and Japan

CARY, N.C., U.S.A. (March 28, 2022) – Veloxis Pharmaceuticals, Inc., an Asahi Kasei company, today announced initiation of study drug dosing in ART-123.PN101, a phase 1 study designed primarily to assess the safety and tolerability of ART-123 (thrombomodulin alfa) in metastatic colorectal cancer patients receiving chemotherapy that includes Oxaliplatin. The ART-123.PN101 study is being conducted jointly with Asahi Kasei Pharma Corp. in the United States and Japan.

2022-02-17

Veloxis Pharmaceuticals’ VEL-101, A Novel Investigational Maintenance Immunosuppressant, Granted FDA Fast-Track Designation

Cary, North Carolina, USA, February 17, 2022 – Veloxis Pharmaceuticals, Inc., an Asahi Kasei company, today announced that VEL-101, a novel investigational maintenance immunosuppressive agent being developed for prophylaxis of renal allograft rejection in patients receiving a kidney transplant, was granted fast track designation by the U.S. Food & Drug Administration (FDA). Fast track designation is granted by the FDA to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need.

2021-09-08

Xenikos Secures €40 Million in Convertible Debt Financing, Veloxis Pharmaceuticals Joins as Strategic Investor

NIJMEGEN, the Netherlands, Sept. 8, 2021 /PRNewswire/ — Xenikos B.V., a clinical-stage biopharmaceutical company currently developing a novel therapy for treating immune related disorders, announced today the closing of €40 million in convertible debt consisting of two equal tranches of €20 million. The financing was led by Veloxis Pharmaceuticals, with participation from existing investors, Medicxi, RA

2021-04-26

OSE Immunotherapeutics and Veloxis Pharmaceuticals Enter Into Global License Agreement to Develop, Manufacture, and Commercialize FR104, a CD28 Antagonist, in the Organ Transplantation Market

Agreement expands Veloxis’s product portfolio and the continued commitment to improving the lives of transplant patients. OSE Immunotherapeutics to receive up to €315 million in potential milestones, including a €7 million upfront, and tiered royalties on sales. PDF Version Nantes, France – Cary, NC, United States, April 26, 2021 – 6:00PM CET — OSE Immunotherapeutics (ISIN:

2020-06-18

Transplant Therapeutics Consortium Receives Acceptance of Letter-of-Intent for iBox Scoring System as a Reasonably Likely Surrogate Endpoint from the Biomarker Qualification Program

Collaboration between the transplant community, industry, and regulatory agencies develops biomarker aimed to streamline the development of novel therapies intended to improve long-term outcomes for kidney transplant recipients. PDF Version Cary, NC, June 18, 2020 — Critical Path Institute (C-Path) announced Wednesday, June 17, that its Transplant Therapeutics Consortium (TTC), of which Veloxis Pharmaceuticals is a member,