Kidney transplantation

Eledon Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Operating and Financial Results

Retrieved on: 
Thursday, March 28, 2024

IRVINE, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its fourth quarter and full year 2023 operating and financial results and reviewed recent business highlights.

Key Points: 
  • In addition to our clinical development progress, tegoprubart was used for immunosuppression in historical kidney and heart pig-to-human xenotransplant procedures.
  • The procedure was completed on March 16, 2024, at Massachusetts General Hospital on a 62-year-old man with end-stage kidney disease.
  • Results were presented at the American Society of Nephrology Kidney Week 2023 Annual Meeting held in Philadelphia, PA in November 2023.
  • General and administrative expenses were $12.7 million for the year ended December 31, 2023, compared to $12.7 million for the year ended December 31, 2022.

Unicycive Therapeutics Announces Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 28, 2024

LOS ALTOS, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the year ended December 31, 2023, and provided a business update.

Key Points: 
  • LOS ALTOS, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the year ended December 31, 2023, and provided a business update.
  • Completed a private placement with new and existing healthcare institutional investors that generated $50 million in gross proceeds to Unicycive.
  • Cash Position: As of December 31, 2023, cash and cash equivalents totaled $9.7 million.
  • Subsequent to year end, in March 2024, Unicycive completed a private placement of preferred stock which generated $50 million in gross proceeds.

Eledon Pharmaceuticals Announces 12th Participant Enrolled in Phase 2 BESTOW Trial Evaluating Tegoprubart for the Prevention of Organ Rejection

Retrieved on: 
Monday, March 25, 2024

IRVINE, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the enrollment of the 12th participant on March 23, 2024, in the Company’s ongoing Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation.

Key Points: 
  • IRVINE, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the enrollment of the 12th participant on March 23, 2024, in the Company’s ongoing Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation.
  • In transplantation procedures, organ rejection is a major cause of graft failure, which can be a life-threatening condition.
  • Rejection occurs due to allorecognition, wherein the recipient's immune system identifies the transplanted organ as foreign tissue, triggering an immune response against the transplanted organ.
  • Calcineurin inhibitors (“CNIs”) are a critical component of most immunosuppressive regimens to prevent acute and long-term organ transplant rejection.

Eledon Pharmaceuticals Announces Use of Tegoprubart in First-ever Transplant of Genetically Modified Kidney from a Pig to a Human

Retrieved on: 
Thursday, March 21, 2024

IRVINE, Calif., March 21, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that tegoprubart, the company’s investigational anti-CD40L antibody, was used as a component of the immunosuppressive treatment regimen following the first-ever transplant of a kidney from a genetically modified pig to a human. The procedure was completed on March 16, 2024, at Massachusetts General Hospital on a 62-year-old man living with end-stage kidney disease.

Key Points: 
  • The procedure was completed on March 16, 2024, at Massachusetts General Hospital on a 62-year-old man living with end-stage kidney disease.
  • “Eledon has now participated in both heart and kidney xenotransplant procedures, further demonstrating tegoprubart’s broad potential in transplant.
  • Tegoprubart has been observed to be safe and well-tolerated in multiple studies and in multiple indications, including for the prevention of rejection following kidney transplantation.
  • In parallel, Eledon is running two global clinical studies evaluating tegoprubart for the prevention of organ rejection in persons receiving a de novo kidney transplant.

Unicycive Therapeutics Delivers Both an Oral and Poster Presentation on UNI-494 at the AKI and CRRT Conference

Retrieved on: 
Wednesday, March 13, 2024

LOS ALTOS, Calif., March 13, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced that two presentations related to UNI-494 were presented on March 12, 2024 at the 29th International Conference on Advances in Critical Care Nephrology AKI and CRRT 2024.

Key Points: 
  • “We are excited about the tremendous progress we have made with our second clinical development asset, UNI-494,” said, Shalabh Gupta, MD, Chief Executive Officer of Unicycive.
  • The oral presentation, entitled, “Intravenous Administration of UNI-494 Ameliorates Acute Kidney Injury in Rat Model of Delayed Graft Function” was delivered by Satya Medicherla, Ph.D., Vice President, Preclinical Pharmacology, Unicycive Therapeutics.
  • The study concluded that UNI-494 is a potential candidate for prevention of DGF and other AKI clinical conditions.
  • The poster, entitled, “UNI-494 Phase 1 Safety, Tolerability and Pharmacokinetics: Trial in Progress” was presented by Guru Reddy, PH.D., Vice President of Preclinical R&D, Unicycive Therapeutics.

Renowned Transplant Surgeon and Medical Innovator, Dr. Robert Mendez, Remembered for Lifelong Dedication to Advancing Organ Donation and Transplantation

Retrieved on: 
Tuesday, April 2, 2024

Along with his twin brother, Dr. Rafael Mendez, Dr. Robert Mendez was a worldwide pioneer in kidney transplantation and organ donation, who revolutionized the field with his expertise and dedication.

Key Points: 
  • Along with his twin brother, Dr. Rafael Mendez, Dr. Robert Mendez was a worldwide pioneer in kidney transplantation and organ donation, who revolutionized the field with his expertise and dedication.
  • View the full release here: https://www.businesswire.com/news/home/20240401597673/en/
    From Left to Right: Dr. Rafael Mendez and Dr. Robert Mendez, organ donation and transplantation pioneers.
  • (Photo: Business Wire)
    Born on March 2, 1937, Dr. Robert Mendez embarked on a remarkable career that spanned over four decades.
  • Dr. Robert Mendez’s impact on the world of organ transplantation, organ donation and medicine at large are immeasurable.

Vertex Announces FDA Clearance of Investigational New Drug Application for VX-407 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Retrieved on: 
Thursday, March 21, 2024

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for VX-407, an investigational first-in-class small molecule corrector that targets the underlying cause of autosomal dominant polycystic kidney disease (ADPKD) in patients with a subset of PKD1 genetic variants.

Key Points: 
  • Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for VX-407, an investigational first-in-class small molecule corrector that targets the underlying cause of autosomal dominant polycystic kidney disease (ADPKD) in patients with a subset of PKD1 genetic variants.
  • ADPKD is the most common inherited kidney disease, with an estimated 250,000 people in the U.S. and Europe living with ADPKD; however, there are no treatments currently available that address the underlying causal biology of the disease.
  • ADPKD is a life-shortening genetic kidney disease characterized by the growth of numerous kidney-enlarging cysts that impair kidney function and can ultimately lead to kidney failure, requiring dialysis or kidney transplantation, and premature death.
  • The majority of ADPKD cases are caused by variants in the PKD1 gene, which encodes the polycystin 1 (PC1) protein.

eGenesis Announces World’s First Successful Transplant of Genetically Engineered Porcine Kidney in a Living Patient

Retrieved on: 
Thursday, March 21, 2024

eGenesis , a biotechnology company developing human-compatible engineered organs to address the global organ shortage, today announced the first ever transplantation of a genetically engineered porcine kidney into a living human recipient.

Key Points: 
  • eGenesis , a biotechnology company developing human-compatible engineered organs to address the global organ shortage, today announced the first ever transplantation of a genetically engineered porcine kidney into a living human recipient.
  • Following the procedure, the patient is in good condition and recovering well at MGH.
  • Yet the demand for organs far outpaces supply, with more than 90,000 individuals on the kidney waitlist and approximately 25,000 kidney transplants performed each year.
  • Decades of progress in cross-species transplantation, accelerated by the advancement of modern genome editing tools and next-generation sequencing, have enabled eGenesis to progress genetically engineered organs to the clinical setting.

Hansa Biopharma publishes 2023 Annual and Sustainability Reports

Retrieved on: 
Thursday, March 21, 2024

LUND, Sweden, March 21, 2024 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" or the "Company" (Nasdaq Stockholm: HNSA), today announced the publication of its 2023 Annual and Sustainability Reports. In 2023, the company made solid progress in both Commercial and R&D priorities and continued its journey to become a default sustainable organization.

Key Points: 
  • LUND, Sweden, March 21, 2024 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" or the "Company" (Nasdaq Stockholm: HNSA), today announced the publication of its 2023 Annual and Sustainability Reports.
  • Peter Nicklin, Chairman of the Board, Hansa Biopharma, said: "2023 was another important year for Hansa Biopharma.
  • Søren Tulstrup, President and CEO, Hansa Biopharma, said: "In 2023, the Company's focus remained firmly on advancing cutting-edge science and delivering new treatments in areas of high unmet need.
  • This is information that Hansa Biopharma AB is obliged to make public pursuant to the Securities Markets Act.

Hansa Biopharma publishes 2023 Annual and Sustainability Reports

Retrieved on: 
Thursday, March 21, 2024

LUND, Sweden, March 21, 2024 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" or the "Company" (Nasdaq Stockholm: HNSA), today announced the publication of its 2023 Annual and Sustainability Reports. In 2023, the company made solid progress in both Commercial and R&D priorities and continued its journey to become a default sustainable organization.

Key Points: 
  • LUND, Sweden, March 21, 2024 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" or the "Company" (Nasdaq Stockholm: HNSA), today announced the publication of its 2023 Annual and Sustainability Reports.
  • Peter Nicklin, Chairman of the Board, Hansa Biopharma, said: "2023 was another important year for Hansa Biopharma.
  • Søren Tulstrup, President and CEO, Hansa Biopharma, said: "In 2023, the Company's focus remained firmly on advancing cutting-edge science and delivering new treatments in areas of high unmet need.
  • This is information that Hansa Biopharma AB is obliged to make public pursuant to the Securities Markets Act.