25 Mar 2025
Two-thirds of patients enrolled in Guard Therapeutics' Phase 2b POINTER study
Guard Therapeutics announced today that it has reached another key milestone in its ongoing clinical development program. Two-thirds of the approximately 160 planned patients have now been enrolled in the Phase 2b POINTER study, which is evaluating the drug candidate RMC-035 as a kidney-protective treatment for patients undergoing open-heart surgery. This patient cohort serves as the basis for the study’s next major milestone – the second of two independent, company-blinded safety reviews. The outcome of this analysis is expected in the second quarter of 2025.
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19 Mar 2025
· Regulatory information
Guard Therapeutics publishes information document regarding rights issue
Guard Therapeutics International AB (publ) ("Guard Therapeutics" or the "Company") (Nasdaq First North Growth Market: GUARD) publishes information document relating to the rights issue of shares of approximately SEK 150.0 million before deduction of issue costs, which was resolved by the Board of Directors on 10 March 2025, by virtue of the authorization granted by the extraordinary general meeting held on 6 March 2025 (the “Rights Issue”). Due to the Rights Issue, the Board of Directors has decided to postpone the annual general meeting to 15 May 2025.
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10 Mar 2025
· Regulatory information
The Board of Directors of Guard Therapeutics has resolved on a previously announced rights issue of approximately SEK 150 million
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27 Feb 2025
· Regulatory information
Guard Therapeutics announces positive outcome from first independent safety data review in Phase 2b POINTER study
Guard Therapeutics announced today that an independent Data Safety Monitoring Committee (DSMC) has completed its first planned review of safety data and has recommended that the Phase 2b clinical study POINTER continue as planned. The committee reviewed safety data from 67 patients, corresponding to more than one-third of the planned number of patients in the study, which evaluates the drug candidate RMC-035 as a kidney protective treatment in open-heart surgery.
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17 Feb 2025
· Regulatory information
Guard Therapeutics intends to resolve on a rights issue of approximately SEK 150 million
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22 Jan 2025
Guard Therapeutics establishes scientific advisory committee to support Phase 3 development of RMC-035
Guard Therapeutics today announced the formation of a new Scientific Advisory Committee comprising seven globally recognized experts in nephrology and drug development. The committee will play a pivotal role in advising on the company’s late-phase development strategy and the design of the upcoming Phase 3 trial for RMC-035, a kidney protective therapy intended for use in open-heart surgery.
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08 Jan 2025
25% of patients recruited in Guard Therapeutics phase 2b POINTER study
Guard Therapeutics today announced that it has reached the important milestone of enrolling 25% of its target in the phase 2b POINTER study. This trial is evaluating the kidney-protective effects of the investigational drug RMC-035 in patients undergoing open-heart surgery. The next major milestone will be the result of the first of two independent, blinded safety analyses, expected in the first quarter of 2025.
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04 Dec 2024
· Regulatory information
Guard Therapeutics presents the Nomination Committee for 2025
Guard Therapeutics International AB (publ) today announced that a Nomination Committee has been appointed in accordance with previous AGM resolutions.
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16 Oct 2024
First patient in Europe dosed in the clinical phase 2b POINTER study
Guard Therapeutics today announced that the first patient in Europe was dosed in the phase 2b POINTER study with the drug candidate RMC-035 as a kidney-protective treatment in open-heart surgery.
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24 Sep 2024
· Regulatory information
Guard Therapeutics announces outcome in rights issue
The board of directors of Guard Therapeutics International AB (publ) (“Guard Therapeutics” or the “Company”) today announces the outcome in the rights issue of shares (repair issue) announced on 27 August 2024 (the “Rights Issue”). The outcome shows that, in total, 227,922 shares were subscribed for by exercise of subscription rights, corresponding to approximately 8.5 per cent of the Rights Issue, and 10,968 shares were subscribed for without subscription rights, corresponding to approximately 0.4 per cent of the Rights Issue. The Rights Issue was thus subscribed to a total of approximately 8.9 per cent, and through the Rights Issue, the Company will receive approximately SEK 7.2 million before transaction costs.
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