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Renalytix plc American Depositary Shares - RNLX STOCK NEWS

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Renalytix plc (NASDAQ: RNLX) is a pioneering company focused on the development of artificial intelligence (AI)-enabled clinical diagnostic solutions for kidney disease, one of the most widespread and costly chronic medical conditions worldwide. The company's flagship product, KidneyIntelX™, is designed to improve the diagnosis, prognosis, and clinical management of kidney diseases, particularly in patients with type II diabetes and those of African ancestry who are at risk of fast-progressing kidney disease. By leveraging advanced AI algorithms, KidneyIntelX aims to enhance patient stratification for drug clinical trials, facilitate drug target discovery, and ultimately reduce the estimated $114 billion annual cost of chronic and end-stage kidney disease to the U.S. healthcare system.

Renalytix plc has achieved significant milestones, including the commercial launch of KidneyIntelX as a laboratory-developed test in its CLIA-certified laboratory facilities. The company's diagnostic solutions are designed to be integrated into health systems and utilized by drug developers for better patient outcomes. Recently, KidneyIntelX received FDA De Novo authorization, marking a significant step towards widespread clinical adoption.

Recent Achievements:

  • Inclusion of KidneyIntelX in clinical guidelines
  • Issuance of a Medicare coverage draft
  • Launch of a direct-to-physician sales force
  • Release of new real-world outcomes evidence
  • Significant year-over-year expense reductions
  • Completion of equity financing
  • Initiation of a strategic sale process

Renalytix plc has also formed strategic partnerships with prominent research institutions such as Mount Sinai, Wake Forest, and Joslin, to advance its research and development efforts. The company's financial strategy includes a plan to further reduce payroll expenses and total general and administrative costs while preserving its sales capacity.

With an unwavering commitment to innovation and patient care, Renalytix plc continues to lead the way in transforming kidney disease diagnosis and treatment, thereby creating substantial value for patients, healthcare providers, and investors alike.

Rhea-AI Summary
Renalytix plc (RNLX) announces positive real-world evidence for KidneyIntelX in slowing chronic kidney disease progression and improving Type 2 diabetes control. The study, including 2,569 patients with Type 2 diabetes and diabetic kidney disease, showed a 61% increase in preventative drug prescriptions among high-risk patients and improved specialist referrals, leading to reduced cost of care and improved patient outcomes. The FDA has issued a de Novo Marketing Authorization for the KidneyIntelX.dkd version of the test, with an addressable market of approximately 14 million patients with adult diabetes and kidney disease.
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Renalytix plc (NASDAQ: RNLX) (LSE: RENX) reported financial results for fiscal Q1 ended September 30, 2023. Recent highlights include ongoing financing discussions, cost-cutting initiatives, FDA authorization of kidneyintelX.dkd, Medicare reimbursement process advancements, senior executive appointment, and distribution agreement execution. The company also revealed first quarter 2024 financial results, with a $0.5 million revenue and a net loss of $10.2 million.
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Renalytix plc (NASDAQ: RNLX) (LSE: RENX) will report its Q1 fiscal year 2024 financial results on November 14, 2023, before market open. A conference call and webcast to discuss the results, business strategy, partnerships, and regulatory processes will follow at 8:30 a.m. (ET) / 1:30 p.m. (GMT).
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Renalytix receives new notice of allowance for patent claims related to kidneyintelX.dkd test
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Renalytix reports financial results for fiscal year 2023, achieving FDA authorization for KidneyIntelX.dkd and securing additional insurance coverage contracts. Maintaining contracted pricing at $950 per test result. Executed over 40 commercial payor contracts and enrolled in 35 state Medicaid programs. Reduction in test volumes at Mount Sinai during commercial insurance billing transition. Appointed Howard Doran as senior diagnostics executive. Full Epic EHR integration with Atrium/Wake Forest underway. Agreement with Veterans Affairs. Milestone achievement in insurance payment availability. Multiple clinical and validation studies presented. KidneyIntelX associated with improved patient outcomes and increased SGLT2-inhibitor drug therapy usage. Completed $20.3 million equity financing. Reduced annual operating expenses by over $11 million. Over 5,000 KidneyIntelX tests performed in FY 2023. Expanded board of directors. Conference call scheduled to discuss financial results and key topics.
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Renalytix plc to report Q4 and full year fiscal 2023 financial results on September 28, 2023
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Renalytix appoints Howard Doran as Chief Business Officer to lead KidneyIntelX global sales effort.
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Renalytix plc (NASDAQ: RNLX) (LSE: RENX) announced clinical data demonstrating that KidneyIntelX in vitro prognostic testing led to improvements in both type 2 diabetes and chronic kidney disease health through 12 months. The results are from a real-world evidence study in New York City, with 2,317 patients. Median A1C levels improved by 0.7% in high-risk patients, and median eGFR slope improved from -7.1 to 4.5ml/min/1.73m2 in high-risk patients.
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FAQ

What is the current stock price of Renalytix plc American Depositary Shares (RNLX)?

The current stock price of Renalytix plc American Depositary Shares (RNLX) is $0.2071 as of October 8, 2024.

What is the market cap of Renalytix plc American Depositary Shares (RNLX)?

The market cap of Renalytix plc American Depositary Shares (RNLX) is approximately 17.2M.

What does Renalytix plc specialize in?

Renalytix plc specializes in developing AI-enabled clinical diagnostic solutions for kidney disease.

What is KidneyIntelX™?

KidneyIntelX™ is a diagnostic product designed to improve the diagnosis, prognosis, and clinical management of kidney diseases.

What are some recent achievements of Renalytix plc?

Recent achievements include FDA De Novo authorization for KidneyIntelX, inclusion in clinical guidelines, and significant expense reductions.

How does Renalytix plc aim to reduce healthcare costs?

By improving the diagnosis and management of kidney diseases, Renalytix plc aims to reduce the estimated $114 billion annual cost of chronic and end-stage kidney disease in the U.S.

Who are some of Renalytix plc's research partners?

Research partners include Mount Sinai, Wake Forest, and Joslin.

What is the significance of FDA De Novo authorization for KidneyIntelX?

FDA De Novo authorization validates the clinical utility of KidneyIntelX, facilitating its widespread clinical adoption.

What strategic measures has Renalytix plc implemented recently?

Measures include expense reductions, equity financing, and initiation of a strategic sale process.

What is the market focus of KidneyIntelX?

KidneyIntelX focuses on patients with type II diabetes and those of African ancestry with fast-progressing kidney disease.

Where is KidneyIntelX commercially available?

KidneyIntelX is available as a laboratory-developed test in Renalytix plc's CLIA-certified laboratory facilities.

How does Renalytix plc contribute to drug development?

Renalytix plc aids drug development by enhancing patient stratification for clinical trials and facilitating drug target discovery through its AI-enabled diagnostic solutions.

Renalytix plc American Depositary Shares

Nasdaq:RNLX

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17.18M
165.93M
4.51%
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0.46%
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