07 Apr 2022
First patient has been dosed in Guard Therapeutics' Phase 2 clinical trial of ROSgard
Guard Therapeutics today announces that the first patient has been dosed in the company's global phase 2 clinical trial of ROSgard. The study is conducted in patients who undergo open heart surgery and thus are at risk of developing acute kidney injury. The results are expected to provide conclusive information on the treatment effect of the investigational drug in this patient group and to guide the design of a subsequent pivotal study.
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12 Jan 2022
Guard Therapeutics receives approval to expand the global phase 2 study of ROSgard to Canada
Guard Therapeutics today announces that the Canadian health authority (Health Canada) has approved the company’s application to conduct and include patients in Canada in the comprehensive phase 2 study of ROSgard, an investigational drug being developed for the prevention and treatment of acute kidney injury. This global study is planned to be conducted in Europe and North America and has since earlier been approved by the German medicines regulator.
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05 Jan 2022
Guard Therapeutics’ application to conduct a phase 2 clinical trial of ROSgard is approved by the German medicines regulator
Guard Therapeutics announces today that the German medicines regulator, the Federal Institute for Drugs and Medical Devices (BfArM), has approved the company’s application to conduct a comprehensive clinical phase 2 study of ROSgard, an investigational drug being developed for the prevention and treatment of acute kidney injury. The global study is planned to be conducted in Europe and North America under the guidance of Prof. Dr. Alexander Zarbock at Münster University Hospital, Germany.
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15 Dec 2021
· Regulatory information
Guard Therapeutics appoints Michael Reusch as Chief Medical Officer
Guard Therapeutics announces today that the company has appointed Dr. Michael Reusch as Chief Medical Officer. Dr. Reusch has over 30 years’ experience in global clinical development and regulatory processes from leading positions in the pharmaceutical industry, most recently in the role of Senior Medical Director at Astellas Pharma. He will take up his new position on 1 January 2022.
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03 Dec 2021
· Regulatory information
Guard Therapeutics announces final result of rights issue
The final result of the rights issue that was announced on 20 October 2021 and where the subscription period ended on 29 November 2021 (the “Rights Issue”) in Guard Therapeutics International AB (publ) (“Guard Therapeutics” or the “Company”), shows that the Rights Issue was subscribed to approximately 41 percent. The remaining approximately 59 percent of the Rights Issue was subscribed for by Rutger Arnhult, through M2 Asset Management AB, and Jan Ståhlberg in accordance with given declarations of intention to subscribe. As a result of the Rights Issue, Guard Therapeutics will receive proceeds amounting to approximately SEK 128 million before issue costs.
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02 Dec 2021
· Regulatory information
Guard Therapeutics announces preliminary result of rights issue
The preliminary result of the rights issue that was announced on 20 October 2021 and where the subscription period ended on 29 November 2021 (the “Rights Issue”) in Guard Therapeutics International AB (publ) (“Guard Therapeutics” or the “Company”), shows that the Rights Issue was subscribed to approximately 41 percent. The remaining approximately 59 percent of the Rights Issue is subscribed for by Rutger Arnhult, through M2 Asset Management AB, and Jan Ståhlberg in accordance with given declarations of intention to subscribe. As a result of the Rights Issue, Guard Therapeutics will receive proceeds amounting to approximately SEK 128 million before issue costs.
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24 Nov 2021
· Regulatory information
Guard Therapeutics publishes supplementary prospectus
Guard Therapeutics International AB (publ) (“Guard Therapeutics” or the “Company”) has prepared a supplementary prospectus (the “Supplementary Prospectus”) to the prospectus that was approved and registered by the Swedish Financial Supervisory Authority (the “SFSA”), and published on 10 November 2021 (the “Prospectus”).
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22 Nov 2021
· Regulatory information
Guard Therapeutics reports positive results from preclinical studies
Guard Therapeutics today reports positive results from preclinical studies of the company’s investigational drug ROSgard in experimental animal models of sepsis. Two independent studies conducted at the Karolinska Institute show that ROSgard reduces the harmful effects that occur in both the liver and kidneys when these organs are exposed to a general inflammation and oxidative stress.
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10 Nov 2021
· Regulatory information
Guard Therapeutics publishes prospectus due to upcoming rights issue
The Board of Directors of Guard Therapeutics International AB (publ) (“Guard Therapeutics” or the “Company”) has, in connection with the Company's upcoming rights issue that was announced on 20 October 2021 (the “Rights Issue”), prepared an EU Growth Prospectus (the “Prospectus”), which today has been approved and registered by the Swedish Financial Supervisory Authority.
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20 Oct 2021
· Regulatory information
Guard Therapeutics carries out, subject to approval from the Extraordinary General Meeting, a directed new issue of approximately SEK 54 million and a rights issue of approximately SEK 128 million
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