Nephrology

Lipella Pharmaceuticals Announces FDA Type C Meeting for LP-10 for Hemorrhagic Cystitis

Retrieved on: 
Wednesday, April 3, 2024
Urinalysis, Type, HC, Patient, History, Tacrolimus, Urine, Ifosfamide, Nephrology, Breast cancer, Hemorrhagic cystitis, Safety, FDA, Cyclophosphamide, Food, Pharmaceutical industry

Lipella expects to meet with the FDA on May 21, 2024.

Key Points: 
  • Lipella expects to meet with the FDA on May 21, 2024.
  • HC is a serious, life-threatening form of gross hematuria (i.e.
  • Lipella published these results in the peer-reviewed journal, International Urology and Nephrology , in September 2023, and received preliminary guidance from the FDA regarding potential registration endpoints.
  • The company’s anticipated Type C meeting with the FDA will focus on reaching an agreement for the proposed Phase-2b trial design, which Lipella expects to be a 36-subject, prospective, double-blind, placebo-controlled study with a primary efficacy assessment derived from the reduction in patient-reported frequency of gross hematuria episodes over a seven-day period.

Spectral Medical Announces Fourth Quarter and Fiscal 2023 Results and Provides Corporate Update

Retrieved on: 
Thursday, March 28, 2024
Emory Healthcare, Sepsis, Conference, SAMI, Motivation, Clinical professor, Partnership, Patient, EAA, Mayo Clinic, Mortality, Septic shock, EDEN, University, Spectral, Intensive care unit, Critical care, PMX, AME Publishing Company, TSX, Clinical trial, Nephrology, ICU, FDA, UCLA, Baxter, Marketing, Economics, Hemoperfusion, Pharmaceutical industry

TORONTO, March 28, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced its financial results for the fourth quarter and for the year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • TORONTO, March 28, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced its financial results for the fourth quarter and for the year ended December 31, 2023 and provided a corporate update.
  • Dr. John Kellum, Chief Medical Officer of Spectral Medical, stated, “We have witnessed robust enrollment activity to start 2024.
  • addition of two new trial sites in the fourth quarter – the Mayo Clinic and Emory Healthcare.
  • The Company concluded the 2023 year with cash of $2,952,000 compared to $8,414,000 cash on hand as of December 31, 2022.

Unicycive Therapeutics to be Featured in Multiple Presentations at the Upcoming European Renal Association Congress

Retrieved on: 
Monday, March 25, 2024
MD, LOS, ERA, European Renal Association, Patient, Kidney disease, Congress, Nephrology, Therapy

LOS ALTOS, Calif., March 25, 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 multiple presentations will be delivered on the Company’s product candidates, oxylanthanum carbonate (OLC) and UNI-494, at the 61st European Renal Association (ERA) Congress taking place May 23-26, 2024, in Stockholm, Sweden.

Key Points: 
  • LOS ALTOS, Calif., March 25, 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 multiple presentations will be delivered on the Company’s product candidates, oxylanthanum carbonate (OLC) and UNI-494, at the 61st European Renal Association (ERA) Congress taking place May 23-26, 2024, in Stockholm, Sweden.
  • Shalabh Gupta, MD, Chief Executive Officer of Unicycive, commented, “The ERA Congress is one of the most prominent nephrology meetings of the year, and we are excited to deliver presentations on both OLC and UNI-494.
  • In addition to presenting preclinical data supporting both of our programs, we will also be reporting on our two clinical trials in progress.
  • We look forward to participating in this important event.”

Checkpoint Therapeutics Reports Full-Year 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Friday, March 22, 2024
Research, CKPT, FASN, Exercise, Biologics license application, Patent, Safety, Immunotherapy, Patient, FACP, Journal, CRL, Society, Nephrology, JITC, File, Marketing, FDA, Hematology, BLA, Alexion

WALTHAM, Mass., March 22, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the full-year ended December 31, 2023, and recent corporate highlights.

Key Points: 
  • WALTHAM, Mass., March 22, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the full-year ended December 31, 2023, and recent corporate highlights.
  • We look forward to providing additional updates in the second quarter.”
    2023 and Recent Corporate Highlights:
    Checkpoint submitted a BLA to the FDA seeking approval of cosibelimab in January 2023 and the FDA accepted the BLA for filing in March 2023.
  • In December 2023, Checkpoint announced that the U.S. Patent and Trademark Office (“USPTO”) issued a new patent (U.S. Patent No.
  • In July 2023, Checkpoint announced new, longer-term data for cosibelimab from its pivotal studies in locally advanced and metastatic cSCC.

XORTX Highlights Achievements of 2023 and Preparation for Registration Clinical Trial

Retrieved on: 
Tuesday, March 19, 2024
Consultant, Nephrology, Provisional application, XRX, Partnership, Chemistry, Kidney disease, Tablet, Orphan, Bryant University, University, EMA, Polycystic kidney disease, Trial of the century, Oxipurinol, MBA, GMP, Diet, PKD, Treatment, Society, Therapy, Patent, Rensselaer Polytechnic Institute, FDA, Marketing, Diagnosis, American Society of Nephrology, Uric acid, Pharmaceutical industry

Dr. Allen Davidoff, CEO of XORTX, stated, “2023 marked a year of substantial clinical, technological and regulatory progress, establishing the foundation for the Company’s 2024 goals.

Key Points: 
  • Dr. Allen Davidoff, CEO of XORTX, stated, “2023 marked a year of substantial clinical, technological and regulatory progress, establishing the foundation for the Company’s 2024 goals.
  • Each of these milestones permit the next step in the Company’s clinical development plan, being a “registration” clinical trial – XRX-OXY-201 in pursuit of accelerated approval and support of the Company’s lead program XRx-008 program for ADPKD.
  • Chemistry and Manufacturing, Clinical and Pre-Clinical Highlights – Produced drug substance for oxypurinol production and produced GMP drug substance; confirmed XORLO™ formulation, produced enhanced bioavailability and produced clinical supply of tablets for clinical trials.
  • August 29, 2023 – XORTX submitted an Orphan Drug Designation application to the EMA for the treatment of ADPKD.

American Kidney Fund Convenes Nation’s Kidney Community for 2024 Kidney Action Week™ March 18-22

Retrieved on: 
Monday, March 18, 2024
American Kidney Fund, Patient, Nephrology, Kidney disease, AKF, Caregiver

ROCKVILLE, Md., March 18, 2024 (GLOBE NEWSWIRE) -- Today, the American Kidney Fund (AKF) kicks off its fifth annual Kidney Action Week ™, the nation’s only free online conference that draws patients, caregivers, nephrologists, researchers and other experts to participate in a weeklong series of sessions related to kidney disease.

Key Points: 
  • ROCKVILLE, Md., March 18, 2024 (GLOBE NEWSWIRE) -- Today, the American Kidney Fund (AKF) kicks off its fifth annual Kidney Action Week ™, the nation’s only free online conference that draws patients, caregivers, nephrologists, researchers and other experts to participate in a weeklong series of sessions related to kidney disease.
  • More than 5,000 people are expected to participate in 2024 Kidney Action Week.
  • The event is part of AKF’s Kidney Month observance, which is focused on equipping and empowering people with the tools they need to prioritize their kidney health and fight kidney disease.

Checkpoint Therapeutics Announces Appointment of Accomplished Life Sciences Executive Amit Sharma, M.D. to Board of Directors

Retrieved on: 
Monday, March 18, 2024
Internal medicine, Circulatory system, Certification, CKPT, FASN, Biotechnology, FACP, Research, University, Nephrology, Society, Marketing, Hematology, Alexion, Bayer, Health, Hypertension, Pharmaceutical industry

WALTHAM, Mass., March 18, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced the appointment of Amit Sharma, M.D., FACP, FASN, FNKF, to its Board as an independent, non-executive director, effective immediately.

Key Points: 
  • WALTHAM, Mass., March 18, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced the appointment of Amit Sharma, M.D., FACP, FASN, FNKF, to its Board as an independent, non-executive director, effective immediately.
  • Prior to joining Alexion, he served as Vice President of Medical Affairs for the Cardiovascular and Renal Division of Bayer Pharmaceuticals.
  • “We are pleased to welcome Dr. Sharma to our Board of Directors,” said James F. Oliviero, President and Chief Executive Officer of Checkpoint.
  • “He is a highly accomplished life sciences executive, with leadership experience in many facets of both patient care and the research, development, approval and commercialization of pharmaceutical products.

IgA Nephropathy Pipeline Dynamics Signal Further Treatment Evolution on the Horizon

Retrieved on: 
Thursday, March 14, 2024
Nephrology, Indoor Living, Novartis, Patient, Alnylam Pharmaceuticals, Perception, SGLT2, Immunoglobulin A, Budesonide, NDA, Record, Breakthrough therapy, UPCR, Atrasentan, Kidney, EGFR, Alexion, FDA, CHMP, Physician, Health, Pharmaceutical industry

For several years, Spherix Global Insights has been closely tracking the IgAN market and recently released its fourth annual US patient chart audit study.

Key Points: 
  • For several years, Spherix Global Insights has been closely tracking the IgAN market and recently released its fourth annual US patient chart audit study.
  • Spherix is the leading authority on IgAN market dynamics and will continue to provide insight into how nephrologists are treating and approaching care for their IgAN patients.
  • Patient Chart Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits.
  • Insights reveal the “why” behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists’ attitudinal & demographic data to highlight differences between stated and actual treatment patterns.

Revolutionizing Chronic Kidney Disease Management on World Kidney Day

Retrieved on: 
Thursday, March 14, 2024
Kidney, Failure, Nephrology, Chronic kidney disease, Disease, Partnership, Business, CKD, Risk, Patient, Evaluation, SVP, Kidney failure, Commercial, Science, Guideline, EGFR, Consumer, Medical device

Toronto, March 14, 2024 (GLOBE NEWSWIRE) -- Today, as the world marks World Kidney Day, LifeLabs, in exclusive partnership with Klinrisk, proudly announces a groundbreaking advancement in chronic kidney disease (CKD) screening and management: the inclusion of the Klinrisk Score as a validated equation in the prestigious Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease , which was released yesterday.

Key Points: 
  • Toronto, March 14, 2024 (GLOBE NEWSWIRE) -- Today, as the world marks World Kidney Day, LifeLabs, in exclusive partnership with Klinrisk, proudly announces a groundbreaking advancement in chronic kidney disease (CKD) screening and management: the inclusion of the Klinrisk Score as a validated equation in the prestigious Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease , which was released yesterday.
  • They will provide an accurate assessment of kidney health for millions affected by this disease, which can, in turn, help guide treatments, medical decisions, or referrals to nephrologists.
  • Together with LifeLabs, Klinrisk is poised to transform CKD management and improve outcomes for the millions affected by this debilitating disease."
  • LifeLabs will promote the Klinrisk test throughout March to raise awareness about the importance of regular testing in managing kidney health.

Alpine Immune Sciences to Present Updated Clinical Data for Povetacicept in IgA Nephropathy at the World Congress of Nephrology 2024

Retrieved on: 
Monday, April 1, 2024
Health, Hospitals, Other Health, General Health, Clinical Trials, Pharmaceutical, Biotechnology, IgA nephropathy, Congress, Immunoglobulin A, Inflammation, Nephrology, Exhibition, Autoimmunity, ALPN, Pharmaceutical industry

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, has announced that the Company will present updated clinical data for povetacicept from RUBY-3, a phase 1b/2a study of povetacicept in autoimmune glomerulonephritis, including IgA nephropathy, in a late breaking poster presentation at the World Congress of Nephrology April 13-16, 2024 in Buenos Aires, Argentina.

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, has announced that the Company will present updated clinical data for povetacicept from RUBY-3, a phase 1b/2a study of povetacicept in autoimmune glomerulonephritis, including IgA nephropathy, in a late breaking poster presentation at the World Congress of Nephrology April 13-16, 2024 in Buenos Aires, Argentina.
  • Concurrently with the poster presentation, the Company will host an investor event on Monday, April 15th.
  • Poster Title: Updated Results from the RUBY-3 study of Povetacicept, an Enhanced Dual BAFF/APRIL Antagonist in IgA Nephropathy
    Presenter: James Tumlin, M.D., Professor of Medicine at Emory University School of Medicine, Founder and CEO of NephroNet Clinical Trials Consortium
    Location: Exhibition Hall and Main Foyer, Buenos Aires Convention Center, Buenos Aires, Argentina