Press releases


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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01 Jun 2022  ·  Regulatory information

Guard Therapeutics receives approval from the Swedish Medical Products Agency to conduct a clinical study of RMC-035 in kidney transplantation

Guard Therapeutics today announces that the company has received approval from the Swedish Medical Products Agency (MPA) to start a clinical phase 1b study with the investigational drug RMC-035 (ROSgard) in patients undergoing kidney transplantation. Through the planned study, the company is thus expanding the clinical development program of RMC-035 into a second indication with significant need for kidney protective treatments. The study will include up to 12 individuals with the primary objective to evaluate the pharmacokinetic properties of RMC-035 in this patient population. The company is expected to present full study results in the first half of 2023.

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26 Apr 2022  ·  Regulatory information

Guard Therapeutics recruits new Head of CMC

Guard Therapeutics announces that the company has appointed Torbjörn Larsson as Head of CMC (Chemistry, Manufacturing and Controls). Torbjörn Larsson will join the management team and will report directly to the CEO.

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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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20 Oct 2021  ·  Regulatory information

Guard Therapeutics intends to carry out a capital raise of approximately SEK 180 million

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15 Sep 2021  ·  Regulatory information

Guard Therapeutics reports positive results from phase 1b study

Guard Therapeutics today presents positive results from a clinical phase 1b study of the potentially kidney-protecting biological investigational drug ROSgard in connection with open heart surgery. The study fulfilled its primary objective – to confirm ROSgard’s favourable safety and tolerability profile in the patient population for which treatment is initially intended. In addition, explorative analyses of several well-established biomarkers indicate that ROSgard potentially has the ability to protect kidney cells from injury associated with heart surgery. The company is now continuing its preparations for a comprehensive clinical phase 2 study.

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09 Apr 2021  ·  Regulatory information

Guard Therapeutics receives an Intention to Grant notice in Europe for ROSgard

Guard Therapeutics AB (publ.) today announces that the company has received an Intention to Grant notice from the European Patent Office (EPO) for a patent application concerning its biological investigational drug ROSgard as a product, including its medical use. The next step in the process is a formal EPO approval, which provides a patent protection until 2037.

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15 Feb 2021  ·  Regulatory information

Guard Therapeutics appoints Sara Thuresson as Head of Clinical Operations

Guard Therapeutics today announces that Sara Thuresson has been recruited to a newly created position as Head of Clinical Operations. She held a similar position at Oncopeptides before joining Guard Therapeutics and will take up her new post on 24 May 2021.

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29 Dec 2020  ·  Regulatory information

Guard Therapeutics completes successful pre-IND meeting with FDA

Guard Therapeutics today announces that the company has completed a pre-IND meeting with the US Food and Drug Administration and has received positive feedback on its planned clinical development programme for its investigational drug ROSgard. This is an important validation of the quality of the project and is a significant step towards an application to include American study centres in future clinical studies (Investigational New Drug Application, IND).

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28 Dec 2020  ·  Regulatory information

Guard Therapeutics appoints Ann-Kristin Myde as Head of Global Project Management

Guard Therapeutics today announces that Ann-Kristin Myde has been appointed new Head of Global Project Management for the company. She will take up her post on 1 April 2021.

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11 Dec 2020  ·  Regulatory information

Guard Therapeutics receives Notice of Allowance from USPTO for ROSgard

Guard Therapeutics AB (publ.) today announces that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for company’s patent application 16/085,500 directed to the biological investigational drug ROSgard as product (composition of matter). A formal approval is expected shortly, and if granted the patent is valid until 2037. The Notice of Allowance further strengthens Guard Therapeutics' patent portfolio and improves market exclusivity for ROSgard in one of the company’s key markets.

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28 Sep 2020  ·  Regulatory information

Guard Therapeutics reports positive top-line results from phase 1 study of ROSgard in individuals with renal impairment

Guard Therapeutics today announced positive top-line results from a phase 1 study of its investigational drug ROSgard in individuals with renal impairment. The main aim of the study was to characterize the pharmacokinetic properties and safety profile of ROSgard in patients with renal impairment. The company believes that these results, together with previously reported positive results from a clinical phase 1 programme in healthy subjects, provide an excellent foundation for continued development of ROSgard in the area of acute kidney injury.

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06 Aug 2020  ·  Regulatory information

Guard Therapeutics announces positive top line results from the concluding study in the clinical phase 1 programme of ROSgard in healthy subjects

Guard Therapeutics today announced positive top line results from the concluding study in the clinical phase 1 programme in healthy subjects where the investigational drug ROSgard was administered in multiple ascending doses (MAD). ROSgard demonstrated good pharmacokinetic properties and a favourable safety profile. The company considers that this provides excellent conditions for continued development of the investigational drug within the field of acute kidney damage and is thus intensifying preparations in advance of forthcoming global patient studies.

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08 Jul 2020  ·  Regulatory information

Guard Therapeutics presents positive follow-up analysis from phase 1 study of ROSgard

Guard Therapeutics (Nasdaq First North Growth Market: GUARD) has today presented follow-up results from a previously completed phase 1 study of ROSgard in single ascending doses (SAD). In particular, the results show that the investigational drug has a favourable effect on a well established biomarker that is used to predict onset of acute kidney injury after cardiac surgery. The study was conducted in healthy subjects.

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06 Jul 2020  ·  Regulatory information

Guard Therapeutics appoints Peter Gilmour as Head of Preclinical Science

Guard Therapeutics has today announced that Peter Gilmour has been appointed Head of Preclinical Science. He has extensive experience in drug discovery and clinical drug development from leading positions at global pharmaceutical companies. Peter Gilmour will be part of the company’s management team and will take up his post on 1 August 2020.

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19 Sep 2019  ·  Regulatory information

A1M Pharma announces positive top-line results from a phase 1a study of ROSgard

A1M Pharma today announced that the results from the initial part of a phase 1a study show that the investigational drug ROSgard™ has a good safety profile and that plasma concentrations that are expected to have a therapeutic effect were achieved. ROSgard is being developed as a potential new treatment for prevention of acute kidney injury in cardiac surgery.

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Guard Therapeutics is a Swedish biotech company that identifies and develops new therapies for diseases with a great medical need for more effective treatments. The company’s investigational drug RMC-035 is being developed as a kidney protective treatment in connection with open heart surgery and kidney transplantation. Guard Therapeutics is listed on Nasdaq First North Growth Market Stockholm.

Mail Address

Guard Therapeutics AB
Box 5216
102 45 Stockholm, Sweden

Visiting Address

Guard Therapeutics
Nybrogatan 34, 2 tr
114 39 Stockholm, Sweden

Telephone

+46 (0)8 670 65 51

E-mail

info@guardtherapeutics.com