CHRONIC KIDNEY DISEASE


Associated tags: Kidney disease, Diabetes, Chronic kidney disease, Type 2 diabetes, Heart failure, Kidney, CKD, Blood, Pharmaceutical industry, Patient, LSE, Hypertension, SALT, EGFR, FDA

Mineralys Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, May 9, 2024

RADNOR, Pa., May 09, 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 dysregulated aldosterone, today announced financial results for the first quarter ending March 31, 2024, and provided a corporate update.

Key Points: 
  • ET –
    RADNOR, Pa., May 09, 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 dysregulated aldosterone, today announced financial results for the first quarter ending March 31, 2024, and provided a corporate update.
  • General and Administrative (G&A) expenses were $4.6 million for the quarter ended March 31, 2024, compared to $2.6 million for the quarter ended March 31, 2023.
  • Total other income, net was $3.9 million for the quarter ended March 31, 2024, compared to $2.3 million for the quarter ended March 31, 2023.
  • Net loss was $31.5 million for the quarter ended March 31, 2024, compared to $12.6 million for the quarter ended March 31, 2023.

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

Retrieved on: 
Thursday, March 21, 2024

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.

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

Retrieved on: 
Thursday, March 14, 2024

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.

New published data demonstrates KidneyIntelX™ has broad implications for winning war on chronic kidney disease

Retrieved on: 
Wednesday, January 10, 2024

LONDON and SALT LAKE CITY, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Renalytix plc (NASDAQ: RNLX) (LSE: RENX) announces publication of Real World Evidence (“RWE”) after 12 months of follow-up in 2,569 patients with Type 2 diabetes and diabetic kidney disease (“DKD”) at a major U.S. health system in Primary Care and Community Health. Results in the diverse cohort, including 27% black patients, demonstrate that electronic health record deployment of KidneyIntelX in vitro prognostic testing was associated with clinical actions that led to a significant slowing of chronic kidney disease progression and improved Type 2 diabetes control most notably in the highest risk patients.

Key Points: 
  • Improved kidney health was evidenced by reduction in the rate of kidney function decline (eGFR slope) and diabetes control was evidenced by improved A1C levels.
  • KidneyIntelX testing achieved scale through electronic health record integration, deploying directly to large treating groups of primary care physicians.
  • KidneyIntelX has received broad insurance payment coverage including through Medicare, Medicaid, and Blue Cross Blue Shield programs.
  • “The demonstrated benefits of KidneyIntelX early risk assessment at one year are significant and go to the core of chronic disease preventative medicine.

Mineralys Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, November 7, 2023

RADNOR, Pa., Nov. 07, 2023 (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 quarter ending September 30, 2023, and provided a corporate update.

Key Points: 
  • ET –
    RADNOR, Pa., Nov. 07, 2023 (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 quarter ending September 30, 2023, and provided a corporate update.
  • Research and Development (R&D) expenses were $22.5 million for the quarter ended September 30, 2023, compared to $6.1 million for the quarter ended September 30, 2022.
  • General and Administrative (G&A) expenses were $3.8 million for the quarter ended September 30, 2023, compared to $1.4 million for the quarter ended September 30, 2022.
  • Net loss was $22.8 million for the quarter ended September 30, 2023, compared to $6.7 million for the quarter ended September 30, 2022.

Hip-Hop Classic "It Takes Two" Takes on New Meaning in Remix to Elevate Importance of Testing for Kidney Disease

Retrieved on: 
Wednesday, November 1, 2023

More than three decades later, the sentiment still rings true, especially when it comes to managing kidney health.

Key Points: 
  • More than three decades later, the sentiment still rings true, especially when it comes to managing kidney health.
  • By turning "It Takes Two" into "It Takes 2 – The Remix," he is helping Boehringer Ingelheim and Lilly reach key audiences to spotlight the significance of complete testing.
  • It Takes 2 encourages healthcare professionals to add UACR testing to screen for CKD, as eGFR testing only tells half the story.
  • By tapping into a powerful combination of nostalgia and memorability, It Takes 2 is helping bring greater recognition to kidney disease."

US Patent Office Allows Patent Claims for Intellectual Property Exclusively Licensed to Renalytix

Retrieved on: 
Friday, October 6, 2023

These claims were filed under US Patent Application No.

Key Points: 
  • These claims were filed under US Patent Application No.
  • 16/671.256 by the Joslin Diabetes Center and this patent is exclusively licensed to Renalytix.
  • KidneyintelX.dkd received Food and Drug Administration de Novo marketing authorization on June 29, 2023.
  • A similar strategy to protect Renalytix’s intellectual property is being pursued in Europe, which also presents a large opportunity for KidneyIntelX expansion.

Renalytix Appoints Senior Executive Howard Doran as Chief Business Officer

Retrieved on: 
Thursday, September 7, 2023

He is a senior executive with over 30 years of diversified general management, strategic planning, and marketing/sales experience in the diagnostics and pharmaceutical industries in domestic and international markets.

Key Points: 
  • He is a senior executive with over 30 years of diversified general management, strategic planning, and marketing/sales experience in the diagnostics and pharmaceutical industries in domestic and international markets.
  • Mr. Doran served as LipoScience, Inc's President and Chief Executive Officer until successful completion of LabCorp’s acquisition of the company in November 2014.
  • Prior to Constitution Medical, Mr. Doran was a member of the senior executive team of Hologic, Inc. and served as President of Hologic's Global Diagnostics business.
  • Earlier intervention and treatment can dramatically alter the trajectory of unsustainable costs associated with this disease,” said Howard Doran.

Mineralys Therapeutics Reports Second Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, August 7, 2023

RADNOR, Pa., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone, today announced financial results for the quarter ending June 30, 2023, and provided a corporate update.

Key Points: 
  • ET –
    RADNOR, Pa., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone, today announced financial results for the quarter ending June 30, 2023, and provided a corporate update.
  • Research and Development (R&D) expenses were $11.9 million for the quarter ended June 30, 2023, compared to $5.6 million for the quarter ended June 30, 2022.
  • General and Administrative (G&A) expenses were $3.9 million for the quarter ended June 30, 2023, compared to $0.9 million for the quarter ended June 30, 2022.
  • Net loss was $12.1 million for the quarter ended June 30, 2023, compared to $6.5 million for the quarter ended June 30, 2022.

Renalytix Clinical Advisory Board Formed to Support Broadening Use of KidneyintelX.dkd

Retrieved on: 
Thursday, August 3, 2023

The confluence of new diagnostic technology, such as kidneyintelX.dkd, and new effective drug therapies, including SGLT2 inhibitors, has swung the door wide open to prevent millions of people from experiencing the life changing effects of uncontrolled kidney disease.

Key Points: 
  • The confluence of new diagnostic technology, such as kidneyintelX.dkd, and new effective drug therapies, including SGLT2 inhibitors, has swung the door wide open to prevent millions of people from experiencing the life changing effects of uncontrolled kidney disease.
  • Clinical actions are most effective for preserving kidney and cardiovascular health in DKD stages 1-3 before significant and irreversible kidney function loss has occurred.
  • Renalytix will engage with the Clinical Advisory Board to provide an urgent call to action for primary care clinicians to diagnose, risk assess and treat their patients with stage 1-3 CKD, specifically in type 2 diabetics.
  • The board will also advise the Company on education and outreach activities to promote adoption of best practices in kidney disease management, appropriate coordination with specialists including nephrologists and endocrinologists, and guideline recommendations.