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Renalytix AI plc (NASDAQ: RNLX) has submitted a clearance request for its KidneyIntelX™ diagnostics to the FDA. This follows the New York State Department of Health granting a clinical laboratory permit for commercial testing. KidneyIntelX aims to enhance kidney disease management, potentially reducing the $120 billion annual cost of kidney disease in the U.S. The FDA filing is based on a validation study involving over 1,100 patients, demonstrating the device's ability to predict progressive kidney function decline in patients over 21 with type 2 diabetes and chronic kidney disease.
Renalytix AI (NASDAQ: RNLX) announced a collaboration with AstraZeneca to enhance precision medicine strategies for chronic kidney disease (CKD). The initiative involves utilizing the KidneyIntelX platform in conjunction with Mount Sinai Health System to optimize treatment protocols and improve patient outcomes. Approximately 700 million individuals globally suffer from CKD, heightening the need for effective therapeutic strategies. The collaboration aims to boost adherence to potassium-binding agents and accelerate clinical trial recruitment, with results expected in early 2021.
On July 21, 2020, Renalytix AI plc (NASDAQ: RNLX) announced the closing of its global offering, raising approximately US$74.3 million through the sale of 11 million new ordinary shares, including 5.485 million American Depositary Shares at US$13.50 each. These shares will be traded on the Nasdaq and the AIM market in London, with trading expected to commence on July 22, 2020. The offering aims to enhance the Company’s financial position as it continues its focus on AI-driven diagnostics for kidney disease.
RenalytixAI has priced its global offering of 11 million new ordinary shares, targeting gross proceeds of approximately US$74.3 million (up to US$85.4 million with underwriter options). The funds will be allocated mainly towards advancing the KidneyIntelX platform and for general corporate purposes. Trading for American Depositary Shares (ADSs) is set to start on Nasdaq under the symbol 'RNLX' on July 17, 2020. The related party transaction involves Mount Sinai's interest to purchase 825,000 ADSs, representing a 15% stake in the enlarged issued capital.
Renalytix AI plc (LSE: RENX) has announced a Global Offering of 11,000,000 ordinary shares, including a public offering in the U.S. as American Depositary Shares ("ADSs") and a private placement in Europe. An option exists for underwriters to purchase an additional 15% of ADSs. The company aims to list ADSs on Nasdaq under the symbol "RNLX" while retaining its AIM listing. J.P. Morgan and Stifel are managing the offering. A registration statement is pending with the SEC, and shares can only be sold once effective.