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Study Demonstrates Ability to Predict Early Rejection in Kidney Transplant with FractalDx Portfolio Technology

NEW YORK, June 7, 2019 /PRNewswire/ — Renalytix AI plc (AIM: RENX), a developer of artificial intelligence-enabled clinical diagnostics for kidney disease, announced today that positive study results have been published in the Journal of Clinical Investigation (JCI) Insight1.  These results show FractalDx portfolio technology can accurately predict early acute …

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Novartis Presents Histology Data with Iscalimab Suggesting the Extended Survival of Transplanted Organs May Be Possible

Basel, June 6, 2019 – Novartis announced today new early stage histology data in kidney transplantation, suggesting that with investigational compound iscalimab (CFZ533) it may be possible to prolong the durability of transplanted kidneys as well as to potentially improve long-term outcomes for kidney transplant patients[1]. “Extending the life of transplanted kidneys …

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Takeda’s Ninlaro Fails to Meet Primary Endpoint in Phase 3 Trial in Patients with AL Amyloidosis

CAMBRIDGE, Mass. & OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) today announced that the Phase 3 TOURMALINE-AL1 clinical trial in patients with relapsed or refractory systemic light-chain (AL) amyloidosis did not meet the first of two primary endpoints. Treatment with NINLAROTM (ixazomib) in combination with dexamethasone did not demonstrate …

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FDA Approves Incyte’s Jakafi for the Treatment of Patients with Acute Graft-Versus-Host Disease

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte Corporation (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi® (ruxolitinib) for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older. Jakafi is the first and only FDA-approved treatment for this indication. “For the first time, patients …

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Mallinckrodt Reports Top-Line Results from Proof-of-Concept Study of Nitric Oxide Gas in Ex-Vivo System of Human Lung Transplants

STAINES-UPON-THAMES, United Kingdom, April 18, 2019 /PRNewswire/ — Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced top-line results from its company-sponsored, proof-of-concept study of nitric oxide gas (gNO) with ex-vivo lung perfusion compared to lung perfusion alone in human lung transplants. The study’s primary objectives were …

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Talaris Therapeutics Announces Promising Phase 2 Data of Novel, Allogeneic Cell Therapy in Living Donor Kidney Transplant Recipients

BOSTON & LOUISVILLE, Ky.–(BUSINESS WIRE)–Talaris Therapeutics, Inc., formerly Regenerex, a privately held biotechnology company developing transformative cell therapies that have the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients, today announced full results of its Phase 2 trial of FCR001 in living donor kidney transplant (LDKT) …

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Natera Announces Publication of Kidney Transplant Validation Study, Demonstrating Superior Data in Detecting Clinical and Subclinical Rejection

SAN CARLOS, Calif., Jan. 7, 2019 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a leader in cell-free DNA, today announced clinical validation study results published in the Journal of Clinical Medicine,1 demonstrating the highly accurate performance of its donor-derived cell-free DNA (dd-cfDNA) test for active allograft rejection in kidney transplant recipients, including higher sensitivity and nearly 18% …

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FDA Grants QIDP and Fast Track Designations to Cidara’s Rezafungin Prophylaxis Development Program

SAN DIEGO–(BUSINESS WIRE)–Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has granted both Qualified Infectious Disease Product (QIDP) and Fast Track designations for the company’s prophylaxis (prevention) development program for lead antifungal product candidate, rezafungin …

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Kalytera Provides Update on its Cannabis-Based Therapy for Prevention and Treatment of GVHD

SAN FRANCISCO and TEL AVIV, Israel, June 21, 2018 (GLOBE NEWSWIRE) — Kalytera Therapeutics, Inc. (TSX-V:KALY) and (OTCQB:KALTF) (the “Company” or “Kalytera”) today provided an update on its lead clinical development program evaluating cannabidiol (“CBD”) for the prevention and treatment of acute graft versus host disease (“GVHD”). GVHD is a …

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FDA Grants Breakthrough Therapy Designation to Omeros’ Therapy for High-Risk HSCT-Associated Thrombotic Microangiopathy

SEATTLE–(BUSINESS WIRE)–Omeros Corporation (NASDAQ: OMER) today announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to OMS721 for the treatment of patients with high-risk hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), specifically those patients who have persistent TMA despite modification of immunosuppressive therapy. This is …

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