CKD

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

Retrieved on: 
Thursday, March 28, 2024
ODD, Research, Hyperphosphatemia, DGF, CRRT, ERA, Administration, Congress, Conference, OLC, CKD, Patient, AKI, National Kidney Foundation, Mitochondrion, NDA, Kidney transplantation, Insurance, Kidney disease, Critical care, Acute kidney injury, Clinical trial, Therapy, Drug development, Safety, Chronic kidney disease, Dialysis, LOS, Research and development, SAD, FDA, KATP, Food, Pharmaceutical industry

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.

Galera Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Thursday, March 28, 2024
Research, HNC, Symantec Endpoint Protection, Head, Type, Manganese, Chronic kidney disease, Incidence, ASN, CKD, New Drug Application, LAPC, Patient, Layoff, CRL, NDA, Cancer, Galera, Workforce, Pancreatic cancer, Clinical trial, Cisplatin, Society, Therapy, GRECO, File, Food, SOM, FDA, PDUFA, Pharmaceutical industry

We are continuing to explore strategic options to maximize value to our shareholders, including a potential development path for avasopasem.

Key Points: 
  • We are continuing to explore strategic options to maximize value to our shareholders, including a potential development path for avasopasem.
  • The Prescription Drug User Fee Act (PDUFA) target date assigned by the FDA for the NDA was August 9, 2023.
  • Research and development expenses were $3.2 million in the fourth quarter of 2023, compared to $8.1 million for the same period in 2022.
  • General and administrative expenses were $2.0 million in the fourth quarter of 2023, compared to $5.0 million for the same period in 2022.

Clinical Data on the Impact of Sotagliflozin on Stroke and Heart Attack Risk Among Four Lexicon-Sponsored Presentations at the American College of Cardiology 73rd Annual Scientific Session & Expo

Retrieved on: 
Monday, March 25, 2024
Shift, Protein kinase B, Cardiology, Stroke, Health, Myocardial infarction, SGLT1, Chronic kidney disease, CKD, Risk, Theatre, Endothelium, Inflammation, Knowledge, SGLT2, Diabetes, HF, University of Colorado, Vessel, University of Michigan, Inhibitor, University, Coagulation, Protein, GDMT, Heart failure, American College, Type 2 diabetes, Vasodilation, Food, Hospital, Pharmaceutical industry

In a post-hoc analysis of data from the 10,584 patients in the SCORED Phase 3 clinical trial, 213 all-cause stroke events occurred, including 29 (13.6%) fatal events.

Key Points: 
  • In a post-hoc analysis of data from the 10,584 patients in the SCORED Phase 3 clinical trial, 213 all-cause stroke events occurred, including 29 (13.6%) fatal events.
  • Sotagliflozin reduced the risk of all-cause stroke by 34%, with 1.2 events per 100 patient-years in the sotagliflozin group and 1.8 events per 100 patient-years in the placebo group.
  • Similarly, sotagliflozin reduced the risk of ischemic stroke by 32%, with 0.8 events per 100 patient-years in the sotagliflozin group and 1.2 events per 100 patient-years in the placebo group.
  • Candidate, University of Michigan, Ann Arbor, Michigan
    Study researchers found that sotagliflozin inhibits platelet activation through simultaneously targeting SGLT1 and SGLT2.

ProKidney Announces Key Leadership Appointments Strengthening Clinical and Technical Operations

Retrieved on: 
Monday, March 25, 2024
Iovance Biotherapeutics, Protagonist, CKD, Patient, Doctor of Philosophy, Senior, Kidney disease, Clinical trial, Manufacturing operations, Therapy, Chemical engineering, Chronic kidney disease, Summit, Lehigh University, BLA, Medical device

WINSTON-SALEM, N.C., March 25, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company”), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced two recent strategic appointments enhancing the leadership team’s expertise in clinical operations and technical operations, positioning the Company for completion of its Phase 3 program and future commercialization. Dr. Ulrich Ernst, PhD joins the Company today as Executive Vice President of Technical Operations, and Mr. Lucio Tozzi was appointed Senior Vice President of Global Clinical Operations on January 22, 2024. Both Dr. Ernst and Mr. Tozzi and will be joining the ProKidney Executive Leadership Team.

Key Points: 
  • Dr. Ulrich Ernst, PhD joins the Company today as Executive Vice President of Technical Operations, and Mr. Lucio Tozzi was appointed Senior Vice President of Global Clinical Operations on January 22, 2024.
  • Both Dr. Ernst and Mr. Tozzi and will be joining the ProKidney Executive Leadership Team.
  • Dr. Ernst was Senior Vice President of Technical Operations at Iovance Biotherapeutics, Chief Operating Officer at Amunix Operating Inc., and Senior Vice President of Manufacturing Operations at Cytovance Biologics.
  • Prior to ProKidney, Mr. Tozzi was Senior Vice President and Head of Clinical Operations at Summit Therapeutics and Rain Oncology, and, prior to that, Vice President of Clinical Operations at Protagonist Therapeutics.

ProKidney Reports Full Year 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Thursday, March 21, 2024
Research, Health, Commercialization, Transplant, CKD, Risk, Patient, AHN, Kidney failure, Biostatistics, CBO, Business development, Overalls, Quality of life, Trial of the century, Kidney disease, CVS Health, Clinical trial, EGFR, Chronic kidney disease, Dialysis, Baxter International, Type, Pharmaceutical industry

WINSTON-SALEM, N.C., March 21, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced financial results for the year ended December 31, 2023.

Key Points: 
  • WINSTON-SALEM, N.C., March 21, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced financial results for the year ended December 31, 2023.
  • In November, the Company announced Dr. Bruce Culleton assumed the role of the CEO and joined the ProKidney board of directors.
  • Dr. Culleton joined ProKidney in July 2023 as Executive Vice President of Clinical Development and Commercialization.
  • Mr. Periera-Kamath had previously joined ProKidney in July 2023 as Vice President of Business Development & Innovative Solutions.

Mineralys Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 21, 2024
Research, American Heart Association, Administration, Conference call, Conference, Target, Obesity, Prevalence, CKD, Part, Patient, SGLT2, G&A, Pivotal, Insurance, Investment, Research and development, AHA, Therapy, EGFR, Senior management, Safety, Chronic kidney disease, Hypertension, Leptin, BMI, Aldosterone, Pharmaceutical industry

RADNOR, Pa., March 21, 2024 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today announced financial results for the fourth quarter and full year ending December 31, 2023, and provided a corporate update.

Key Points: 
  • R&D expenses for the quarter ended December 31, 2023 were $23.7 million, compared to $7.8 million for the quarter ended December 31, 2022.
  • G&A expenses were $4.0 million for the quarter ended December 31, 2023, compared to $2.2 million for the quarter ended December 31, 2022.
  • Total other income, net was $3.3 million for the quarter ended December 31, 2023, compared to $0.9 million for the quarter ended December 31, 2022.
  • Net loss was $24.4 million for the quarter ended December 31, 2023, compared to $9.1 million for the quarter ended December 31, 2022.

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.

KidneyIntelX™ included in Final KDIGO 2024 Clinical Guideline for Chronic Kidney Disease (CKD)

Retrieved on: 
Thursday, March 14, 2024
Chronic kidney disease, Type 2 diabetes, Disease, CKD, GFR, Risk, Kidney disease, Patient, Evaluation, Doctor of Philosophy, MD, Risk assessment, EGFR, World Kidney Day, Prognosis, FDA, Guideline, Nursing

LONDON and SALT LAKE CITY, March 14, 2024 (GLOBE NEWSWIRE) -- Renalytix plc (NASDAQ: RNLX) (LSE: RENX) (Renalytix) announces that the KidneyIntelX In-Vitro Diagnostic test has been included in the final KDIGO (Kidney Disease Improving Global Outcomes) 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (CKD), published on March 13, 2024.

Key Points: 
  • LONDON and SALT LAKE CITY, March 14, 2024 (GLOBE NEWSWIRE) -- Renalytix plc (NASDAQ: RNLX) (LSE: RENX) (Renalytix) announces that the KidneyIntelX In-Vitro Diagnostic test has been included in the final KDIGO (Kidney Disease Improving Global Outcomes) 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (CKD), published on March 13, 2024.
  • In the release of the new guideline, timed to coincide with World Kidney Day on March 14, the KDIGO committee highlighted the role of risk prediction in guiding care for patients.
  • In this context, KidneyIntelX is recommended for use as an externally validated tool for predicting disease progression in people with CKD stages G1-G3.
  • In the KDIGO announcement of the publication of the 2024 CKD guideline, Adeera Levin MD, one of the Guideline Committee Co-Chairs said, “Recent advancements in GFR evaluation, risk prediction, and the arrival of novel treatments are poised to enhance CKD prognosis and management.

Mineralys Therapeutics to Announce Fourth Quarter and Full Year 2023 Financial Results and Host Conference Call on Thursday, March 21, 2024

Retrieved on: 
Wednesday, March 13, 2024
Chronic kidney disease, CKD, Therapy, Hypertension

RADNOR, Pa., March 13, 2024 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today announced it will report its financial results from the fourth quarter and full year ended December 31, 2023, before the financial markets open on Thursday, March 21, 2024.

Key Points: 
  • RADNOR, Pa., March 13, 2024 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today announced it will report its financial results from the fourth quarter and full year ended December 31, 2023, before the financial markets open on Thursday, March 21, 2024.
  • Thursday, March 21st @ 8:30 a.m.
  • ET

New Post Hoc Analysis of inTandem3 Study Demonstrates Improvements In Glycemic Control With Sotagliflozin Treatment in Patients With Type 1 Diabetes and Chronic Kidney Disease

Retrieved on: 
Tuesday, March 12, 2024
Human, Conference, ATTD, CKD, Patient, Diabetes, EGFR, Safety, Chronic kidney disease, DKA, Hypoglycemia, Pharmaceutical industry

In this important patient population, treatment with sotagliflozin successfully lowered A1C, body weight, and systolic blood pressure with safety similar to the total study cohort.

Key Points: 
  • In this important patient population, treatment with sotagliflozin successfully lowered A1C, body weight, and systolic blood pressure with safety similar to the total study cohort.
  • The efficacy and safety data were presented last week at ATTD 2024 - 17th International Conference on Advanced Technologies and Treatments for Diabetes in Florence, Italy.
  • Relative to placebo, treatment with sotagliflozin led to similar reductions in A1C, body weight and systolic blood pressure in the CKD and total cohorts.
  • “We are optimistic that sotagliflozin may become an important new treatment option for this important population.”