Latest Cardiac Safety News

Argenica has completed the last FDA-mandated cardiac safety assay for its stroke drug ARG-007, paving the way to lift the clinical hold and initiate Phase 2b trials in the US.

Argenica Therapeutics has passed a critical FDA genotoxicity test for its stroke drug ARG-007, advancing its IND application and edging closer to Phase 2b clinical trials in the US and Australia.

Argenica Therapeutics is progressing its ARG-007 drug toward a targeted Phase 2b trial for acute ischaemic stroke, leveraging AI for patient selection and securing key regulatory approvals, while maintaining a solid cash position of $8 million.

The FDA has removed the postmarketing cardiac repolarization study requirement for Clinuvel's SCENESSE®, reflecting confidence in its long-term safety profile. This marks a regulatory milestone for the only approved treatment for erythropoietic protoporphyria in the US.

Noxopharm has successfully completed key in vitro safety tests for its SOF-SKN™ lupus drug, paving the way for the upcoming HERACLES Phase 1 clinical trial.