Chronic kidney disease

SeaStar Medical-Sponsored Symposium Featuring Experts Discussing Pediatric Acute Kidney Injury and the Selective Cytopheretic Device to be Webcast Live at AKI & CRRT 2024

Retrieved on: 
Monday, March 11, 2024
Chronic kidney disease, FAAP, Multiple organ dysfunction syndrome, Medical director, Critical care, FDA, CKRT, SCD, Hospital, Risk, Conference, University, SeaStar, Acute kidney injury, AKI, CRRT, Nephrology, Pharmaceutical industry

DENVER, March 11, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces its sponsorship of an Industry Symposium titled “New Therapies in Pediatric Acute Kidney Injury” on March 13, 2024 at the 29th International Conference on Advances in Critical Care Nephrology – Updates in ICU Medicine: Controversies, Challenges and Solutions (AKI & CRRT 2024). The hybrid in-person and virtual conference is being held March 12-15 in San Diego.

Key Points: 
  • The hybrid in-person and virtual conference is being held March 12-15 in San Diego.
  • “Despite advancements in kidney replacement therapy, mortality rates in children with acute kidney injury (AKI) and multi-organ failure requiring continuous kidney replacement therapy (CKRT) remain at about 50%, and children who survive an AKI episode are at elevated risk of chronic kidney disease.
  • “It’s exciting to have recognized leaders in AKI and nephrology who serve on the SeaStar Medical Scientific Advisory Board participate in this symposium.
  • The discussion will highlight our technology, clinical data and the recent FDA approval of the SCD-PED, the first therapeutic device in our Quelimmune product family,” said Kevin Chung, MD, SeaStar Medical’s Chief Medical Officer.

Lexicon Preparing to Resubmit Sotagliflozin NDA for Type 1 Diabetes Following Feedback From FDA

Retrieved on: 
Monday, March 11, 2024
Chronic kidney disease, Lexicon, CRL, New Drug Application, FDA, CKD, Diabetes, Patient, Hearing, NDA, Pharmaceutical industry

THE WOODLANDS, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that, following the receipt of recent feedback from FDA, it is preparing to resubmit its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in patients with type 1 diabetes and chronic kidney disease (CKD). The resubmission is planned for mid-year, with an anticipated six-month regulatory review period.

Key Points: 
  • THE WOODLANDS, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that, following the receipt of recent feedback from FDA, it is preparing to resubmit its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in patients with type 1 diabetes and chronic kidney disease (CKD).
  • The resubmission is planned for mid-year, with an anticipated six-month regulatory review period.
  • “We have remained steadfast in our support of sotagliflozin in type 1 diabetes and have worked diligently to identify a regulatory path forward for what we believe will be an important new therapy,” said Lonnel Coats, Director and Chief Executive Officer.
  • Lexicon and FDA subsequently agreed in late 2023 to hold the NOOH proceedings in abeyance in order to engage in discussions regarding a path forward for resubmission and potential approval of the NDA.

Lexicon Pharmaceuticals Reports Fourth Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, March 11, 2024
Research, New Drug Application, American Heart Association, Investment, Obesity, Growth, EASD, Arrowhead Conference, Patient, Chronic kidney disease, Post hoc, Neuropathic pain, Marketing, Heart failure, Hypertension, Hypertrophic cardiomyopathy, Left ventricular hypertrophy, NDA, Express, PROGRESS, AAK1, Risk, Conference, HCM, Clinical trial, Neuroscience, Lexicon, FDA, Research and development, Cardiology, U.S. FDA, Medicare, Administration, Travel, Pharmaceutical industry

ET

Key Points: 
  • ET
    THE WOODLANDS, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended December 31, 2023 and provided an update on key corporate milestones.
  • “2023 was a pivotal year for Lexicon,” said Lonnel Coats, Lexicon’s chief executive officer.
  • Unless otherwise stated, all comparisons are for the fourth quarter and full year of 2023 compared to the fourth quarter and full year of 2022.
  • Revenues: Revenues for the fourth quarter and full year of 2023 were $0.7 million and $1.2 million, respectively, primarily from the commercialization of INPEFA.

Unicycive Therapeutics Completes Enrollment in Pivotal Clinical Trial for Oxylanthanum Carbonate (OLC)

Retrieved on: 
Thursday, March 7, 2024
Chronic kidney disease, LOS, MD, Physician, FDA, Dialysis, Food, CKD, Hyperphosphatemia, Safety, Therapy, Pharmacokinetics, Patient, Clinical trial, Kidney disease, NDA, Pharmaceutical industry

LOS ALTOS, Calif., March 07, 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 enrollment has been completed in the open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC).

Key Points: 
  • LOS ALTOS, Calif., March 07, 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 enrollment has been completed in the open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC).
  • OLC is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
  • “The completion of enrollment in our pivotal OLC clinical trial is a critical achievement for Unicycive as we strive to bring an improved therapy to chronic kidney disease patients struggling with hyperphosphatemia,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive.
  • “Positive results from the trial will provide the basis to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA).

Scilex Holding Company Sets Launch Price of $595 per 150ml bottle of Gloperba®, its First and Only Liquid Oral Version of the Anti-Gout Medicine Colchicine Indicated for the Prophylaxis of Painful Gout Flares in Adults; Expected Plans to Launch in the Fir

Retrieved on: 
Tuesday, March 5, 2024
PALO, Chronic kidney disease, Rheumatology, Toxicity, ACR, Diarrhea, FDA, Colchicine, Gout, Pharmacy, Risk, Migraine, Health care, Chronic pain, American College, Patient, Pharmaceutical industry

Gloperba® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.

Key Points: 
  • Gloperba® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.
  • Gout is a painful arthritic disorder affecting an estimated 9.2 million people in the United States1.
  • These patients may benefit from flexible dosing offered by Gloperba®4
    Scilex plans to launch Gloperba® in the first half of 2024 with a launch price of $595 per 150ml bottle of liquid colchicine formulation.
  • Gloperba is the only FDA approved liquid formulation of colchicine for the prophylaxis of acute gout flares.

ProKidney to Participate in Jefferies Biotech on the Bay Summit

Retrieved on: 
Thursday, February 29, 2024
Jefferies, CKD, Chronic kidney disease

WINSTON-SALEM, N.C., Feb. 29, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney”), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced that senior members of the management team will be participating in the Jefferies Biotech on the Bay Summit being held in Miami on March 12 – 13, 2024.

Key Points: 
  • WINSTON-SALEM, N.C., Feb. 29, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney”), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced that senior members of the management team will be participating in the Jefferies Biotech on the Bay Summit being held in Miami on March 12 – 13, 2024.
  • The ProKidney management team will host one-on-one meetings during the event.
  • Interested investors should contact their Jefferies representative to schedule meetings.

FibroGen Regains All Rights to Roxadustat from AstraZeneca in the United States and Other AstraZeneca Territories, Except China and South Korea

Retrieved on: 
Monday, February 26, 2024
SAN, Chronic kidney disease, AstraZeneca, Anemia, ASH, CKD, MDS, Patient, Disease, Pharmaceutical industry

SAN FRANCISCO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) announced today that FibroGen and AstraZeneca have agreed to terminate the U.S./RoW roxadustat collaboration agreement entered into on July 30, 2013, under which AstraZeneca held development and commercialization rights in the United States and other territories outside of China not licensed to Astellas Pharma Inc. Pursuant to a termination and transition agreement entered into between the parties, AstraZeneca is returning all U.S./RoW roxadustat rights to FibroGen (with the exception of South Korea) and providing certain assistance during a transition period. FibroGen’s collaboration agreement with AstraZeneca for roxadustat in China remains in place and roxadustat remains the leader in China by brand value share in the chronic kidney disease (CKD) anemia category. In the event FibroGen subsequently monetizes or commercializes roxadustat in the territories formerly licensed under the U.S./RoW collaboration agreement, FibroGen will have certain financial obligations to AstraZeneca.

Key Points: 
  • SAN FRANCISCO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) announced today that FibroGen and AstraZeneca have agreed to terminate the U.S./RoW roxadustat collaboration agreement entered into on July 30, 2013, under which AstraZeneca held development and commercialization rights in the United States and other territories outside of China not licensed to Astellas Pharma Inc. Pursuant to a termination and transition agreement entered into between the parties, AstraZeneca is returning all U.S./RoW roxadustat rights to FibroGen (with the exception of South Korea) and providing certain assistance during a transition period.
  • FibroGen’s collaboration agreement with AstraZeneca for roxadustat in China remains in place and roxadustat remains the leader in China by brand value share in the chronic kidney disease (CKD) anemia category.
  • In the event FibroGen subsequently monetizes or commercializes roxadustat in the territories formerly licensed under the U.S./RoW collaboration agreement, FibroGen will have certain financial obligations to AstraZeneca.
  • “We continue to believe that roxadustat represents an important potential therapy for patients in the U.S. and other territories where it has not yet been approved,” said Thane Wettig, FibroGen Chief Executive Officer.

Simple HealthKit Launches Expanded Kidney Health Evaluation for Patients with Diabetes (KED) Program to Help Payers Improve Patient Health, Boost STAR Ratings & Meet HEDIS Measures

Retrieved on: 
Monday, February 26, 2024
Chronic kidney disease, HEDIS, Social, Dialysis, Simple, KED, DIY, Government, STAR, Conference, University, Risk, CKD, Medicare, ViVe, Patient, Health (Apple), Kidney, Kidney failure

At the heart of the program is Simple HealthKit’s new Expanded Kidney Health Test, which evaluates kidney function and kidney damage, and is available via in-clinic or at-home settings.

Key Points: 
  • At the heart of the program is Simple HealthKit’s new Expanded Kidney Health Test, which evaluates kidney function and kidney damage, and is available via in-clinic or at-home settings.
  • Diabetes is the leading cause of chronic kidney disease (CKD)—about 1 in 3 adults with diabetes have CKD.
  • At-home kidney health tests could drastically reduce Medicare expenditures associated with CKD, while boosting Star Ratings, and satisfying KED HEDIS® measures for MY2024.
  • Simple HealthKit already works with multiple payers across the U.S. including government agencies, universities and private healthcare plans like Imperial Health.

Ardelyx Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, February 22, 2024
Fosun Pharma, Kyowa Kirin, Research, New Drug Application, Investment, Dialysis, Growth, Sale, Death, Diarrhea, Webcast, Abdominal distension, Orphan, XBR, Chronic kidney disease, Incidence, Peritoneal dialysis, Rat, Record, Calendar, ESG, CKD, Hyperphosphatemia, Safety, Human, Nephrology, IBS-C, Master of Science, Gastroenterology, FDA, Food, Social, Emeritus, Dehydration, Risk, Constipation, Society, Patient, Pharmaceutical industry

WALTHAM, Mass., Feb. 22, 2024 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a business update.

Key Points: 
  • During the fourth quarter of 2023, IBSRELA U.S. net product sales revenue was $28.1 million, reflecting 26% growth compared to the third quarter of 2023.
  • Ardelyx currently expects full-year 2024 U.S. net product sales revenue for IBSRELA to be between $140.0 and $150.0 million.
  • U.S. net product sales revenue in the fourth quarter of 2023 were $2.5 million.
  • U.S. net product sales revenue in 2023 for XPHOZAH was $2.5 million following its commercial launch in November 2023.

Where You Live Impacts Your Ability to Save a Life Through Living Organ Donation, According to the 2024 American Kidney Fund Report Card

Retrieved on: 
Thursday, February 22, 2024
Ambassador, Chronic kidney disease, Health insurance, American Kidney Fund, Latino, AKF, Dialysis, News, Report card, Transplant, Skin, Life, HIPP, CKD, Disability, House, FMLA, Telephone numbers in Hungary, Policy, Family, Legislation, Louisiana House of Representatives, Patient, Kidney disease, Insurance, Kidney, Representative, Child, Health equity, The Report Card, Mortality, Research, Senate, Kidney failure

Receiving a kidney from a living donor is the best option for someone in need of a new kidney.

Key Points: 
  • Receiving a kidney from a living donor is the best option for someone in need of a new kidney.
  • However, six states – Alabama, Montana, New Hampshire, Tennessee, South Dakota and Vermont – have zero policy protections (F grade) for living organ donors.
  • How All 50 States + DC Fared on the 2024 State of the States: American Kidney Fund Report Card
    Currently, chronic kidney disease (CKD) affects more than 1 in 7 adults in the U.S.
  • “Where you live should not impact whether you are able to save a life through kidney donation, but our 2024 Report Card suggests that this may be the case.