05 Oct 2025
· Regulatory information
Guard Therapeutics Announces New Positive Efficacy Results from Secondary Analyses of the Phase 2a AKITA Study
Guard Therapeutics (publ) today announced favorable efficacy results from additional analyses of the Phase 2a AKITA study with the investigational drug candidate RMC-035. The previously reported primary results demonstrated a robust improvement in kidney function following open-heart surgery. The new analyses strengthen these findings and show that RMC-035 provides kidney-protective benefits both in patients with and without acute kidney injury, and additionally reduces key biomarkers of kidney damage, including albuminuria, further supporting its kidney-protective potential. Selected results will be presented at the leading U.S. scientific conference ASN Kidney Week 2025.
Read more
11 Sep 2025
Guard Therapeutics announces completion of data collection in Phase 2b POINTER study
Guard Therapeutics (publ) today announced that the last patient in its ongoing Phase 2b clinical trial, POINTER, has successfully completed the final scheduled follow-up visit 90 days after surgery (last patient last visit). The study is evaluating the company’s drug candidate, RMC-035, as a kidney-protective treatment for patients undergoing open-heart surgery.
Read more
28 Aug 2025
Guard Therapeutics presents additional AKITA results at leading U.S. nephrology conference
Guard Therapeutics (publ) today announced that additional results from the Phase 2 AKITA study with the company’s drug candidate RMC-035 will be presented at the scientific conference Kidney Week 2025 organized by the American Society of Nephrology (ASN), in Houston, TX, USA. The new results are based on post hoc analyses of the previously completed and reported study and provide deeper insights into the potential of RMC-035 to preserve kidney function after open-heart surgery.
Read more
22 Aug 2025
Guard Therapeutics to present at upcoming investor conferences
Guard Therapeutics (publ) today announced that the company will present at the following investor conferences ahead of the upcoming readout of the Phase 2b POINTER study:
Read more
21 Aug 2025
· Regulatory information
Guard Therapeutics publishes interim report January–June 2025
The quarter marked a key milestone with the completion of patient recruitment for our Phase 2b POINTER study – ahead of schedule. The positive final safety review reinforces confidence in the trial, underscoring strong momentum and positioning us well for future value creation.
Read more
05 Jun 2025
Guard Therapeutics announces completion of patient enrollment in Phase 2b POINTER study
Guard Therapeutics (publ) today announced that the last patient has been successfully enrolled in the company’s ongoing Phase 2b clinical trial, POINTER, evaluating the drug candidate RMC-035 as a kidney-protective therapy in patients undergoing open-heart surgery.
Read more
27 May 2025
· Regulatory information
Guard Therapeutics reports positive outcome from second planned safety review in the Phase 2b POINTER study
Guard Therapeutics today announced that an independent Data Safety Monitoring Committee (DSMC) has completed the second and final planned review of safety data from the ongoing Phase 2b clinical trial, POINTER, which is evaluating the kidney-protective effects of the drug candidate RMC-035 in connection with open-heart surgery. The company has received a favourable and unanimous recommendation from the DSMC to proceed with the study as planned, as no safety concerns have been identified.
Read more
21 May 2025
Guard Therapeutics to present Phase 2b POINTER study design at scientific conference
Guard Therapeutics (publ) today announced that the design of its ongoing Phase 2b clinical trial, POINTER, will be presented at the annual congress of the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) in Vienna, Austria.
Read more
11 Apr 2025
· Regulatory information
Guard Therapeutics announces changes in number of shares and votes
Guard Therapeutics International AB (publ) (“Guard Therapeutics” or the “Company”) today announced that the number of shares and votes in the Company has changed due to the recently completed Rights Issue (for further information, see the Company’s press release on April 4, 2025).
Read more
04 Apr 2025
· Regulatory information
Guard Therapeutics announces outcome of the rights issue
Guard Therapeutics International AB (publ) (“Guard Therapeutics” or the “Company”), (Nasdaq First North Growth Market: GUARD) announced on 10 March 2025 that the Board of Directors had resolved, by virtue of the authorization granted by the extraordinary general meeting held on 6 March 2025, on a rights issue of shares of approximately SEK 150 million (the “Rights Issue”). The subscription period ended on 3 April 2025. Guard Therapeutics hereby announces that the final result of the Rights Issue shows that 6,852,654 shares, corresponding to approximately 69.7 percent of the Rights Issue, were subscribed for with and without exercise of subscription rights. Accordingly, 1,020,099 shares, corresponding to approximately 10.4 percent of the Rights Issue, will be allotted to the guarantors, whereby the Rights Issue is subscribed to in aggregate approximately 80.0 percent. Guard Therapeutics will receive proceeds amounting to approximately SEK 120 million before deduction of costs attributable to the Rights Issue.
Read more