Guard Therapeutics International AB (publ) (“Guard Therapeutics” or the “Company”) has, due to the Company’s upcoming rights issue of shares, that was announced on 27 August 2024 (the “Rights Issue”), prepared an EU Growth Prospectus (the “Prospectus”), which today has been approved and registered by the Swedish Financial Supervisory Authority (Sw. Finansinspektionen).
Guard Therapeutics today announced that the first patient has been dosed in the phase 2b clinical study POINTER with the drug candidate RMC-035 as a kidney-protective treatment in open-heart surgery.
The board of directors of Guard Therapeutics International AB (publ) (“Guard Therapeutics” or the “Company”), in accordance with the announcement of a non-guaranteed rights issue (repair issue) which was communicated through the Company’s press release on 17 June 2024, has today resolved to carry out a new issue of shares with preferential rights for the Company’s existing shareholders (the “Rights Issue”) based on the authorization granted by the extraordinary general meeting on 3 July 2024. The Rights Issue is mainly carried out to compensate the shareholders that did not participate in the directed share issue that the board of directors of the Company resolved upon on 17 June 2024 (the “Directed Share Issue”) by offering the Company’s shareholders the opportunity to defend their share ownership on the same terms as in the Directed Share Issue.
Guard Therapeutics announced today that, through the European application procedure, the company has received authorization from regulatory authorities and ethics committees in Spain, Germany, and the Czech Republic to include patients in the clinical Phase 2b study POINTER with the drug candidate RMC-035 as a kidney-protective treatment in open-heart surgery.
Guard Therapeutics today announced that the scientific journal American Journal of Physiology – Renal Physiology has published an article summarizing important preclinical results of the company's clinical drug candidate RMC-035. The results consistently demonstrate positive effects of RMC-035 in a large number of models for kidney injury and provide clear support for its continued clinical development as a renal protective treatment in open-heart surgery.
Guard Therapeutics today announced that Health Canada has approved the company's application to include patients in Canada in its phase 2b clinical study of RMC-035 as a kidney protective treatment in open heart surgery.
Guard Therapeutics [GUARD], a biotechnology company specializing in kidney diseases, announced today that the company conducted a digital R&D Update on January 30, 2024. The presentation included an update on next development steps for the drug candidate RMC-035 and progress within the preclinical development platform of new peptides intended for chronic treatment. A recording of the presentation is available on the company's website.
Guard Therapeutics [GUARD], a biotechnology company specialized in kidney diseases, announced today that the company is organizing a digital R&D Update on January 30, 2024, from 14:00 to 15:30. The company will discuss the results of the completed Phase 2 AKITA study and the continued development plan for the company’s lead candidate RMC-035. New preclinical results from the company's peptide platform will also be presented. In addition to Guard Therapeutics CEO Tobias Agervald and Chief Medical Officer Michael Reusch, Dr. David Goldsmith, Adjunct Professor of Nephrology, King's College, London, will also participate and provide an external perspective on the AKITA results.
Guard Therapeutics [GUARD], a biotechnology company specializing in kidney diseases, today announced that the United States Food and Drug Administration (FDA) has provided positive feedback regarding the continued development of the company's leading drug candidate RMC-035 in open-heart surgery. The next developmental step includes a phase 2b study with the aim of identifying an optimal dosage of RMC-035. The phase 2b study is also expected to enable the most efficient design of a subsequent pivotal phase 3 study.