20 Feb 2023
Results from Guard Therapeutics' Phase 1b study in cardiac surgery published in Kidney International Reports
Guard Therapeutics [GUARD] today announced that the results from its Phase 1b clinical trial of RMC-035 in patients undergoing open heart surgery have been published in the scientific journal Kidney International Reports. The Phase 1b study met its primary objective and has formed the basis for the company's ongoing Phase 2 clinical trial AKITA.
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16 Feb 2023
First US patient dosed in Guard Therapeutic’s Phase 2 AKITA study
Guard Therapeutics [GUARD] today announced that the first patient in the US has been dosed with study drug in the ongoing global Phase 2 clinical trial AKITA. The main study objective is to evaluate the kidney-protective effect of RMC-035 in patients who are at increased risk of developing acute kidney injury in connection with open heart surgery.
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10 Feb 2023
Half of the patients dosed in the Phase 2 AKITA study
Guard Therapeutics [GUARD] today announced that 134 of the planned 268 patients have been dosed in the global randomized, double-blinded and placebo-controlled Phase 2 clinical trial (AKITA). The AKITA study has been designed to evaluate the kidney-protective effects of the investigational drug RMC-035 in conjunction with open heart surgery. An interim analysis will be conducted by an independent Data Monitoring Committee (DMC) who will provide a recommendation in April regarding the continuation of the study.
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09 Jan 2023
· Regulatory information
Guard Therapeutics receives patent approval for RMC-035 in China
Guard Therapeutics today announces that the company has received a grant from the Chinese Patent Office (China National Intellectual Property Administration) for its patent application no. 201780018244.4 that protects the company's biological investigational drug RMC-035 as a product.
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20 Dec 2022
· Regulatory information
Guard Therapeutics presents the Nomination Committee for 2023
Guard Therapeutics International AB (publ) today announces that a Nomination Committee has been appointed in accordance with previous AGM resolutions.
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10 Nov 2022
· Regulatory information
Guard Therapeutics has decided to carry out a directed share issue of SEK 120 million, partly subject to subsequent approval by an extraordinary general meeting
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10 Nov 2022
· Regulatory information
Guard Therapeutics explores the conditions to carry out a directed share issue of approximately SEK 115 million
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08 Nov 2022
· Regulatory information
Guard Therapeutics granted FDA Fast Track designation for RMC-035
Guard Therapeutics today announces that the U.S. Food and Drug Administration (FDA) has granted RMC-035 (ROSgard) Fast Track designation for reducing the risk of an irreversible loss of kidney function, initiation of kidney replacement therapy or death following open-chest cardiac surgery in patients who are at increased risk for acute kidney injury. FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drugs aimed at treating serious conditions which have a large unmet medical need, with the goal to provide patients earlier access to such drugs.
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10 Oct 2022
· Regulatory information
Guard Therapeutics receives IND approval from the FDA for RMC-035
Guard Therapeutics today announces that the U.S. Food and Drug Administration (FDA) has granted the company's Investigational New Drug (IND) application for the investigational drug RMC-035 (ROSgard). The approval enables expansion of the clinical development program for RMC-035 to the US, including the ongoing global and placebo-controlled Phase 2 study AKITA in cardiac surgery.
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23 Sep 2022
Presentations from Guard Therapeutics' Capital Markets Day are now available on the company's website
On September 21, 2022, Guard Therapeutics hosted a Capital Markets Day at Erik Penser Bank in Stockholm to provide an update on the company's development projects and the clinical strategy for the investigational drug RMC-035 (ROSgard). The presentations were recorded and are now available on the company's website.
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