CalciMedica says FDA review clears Auxora dosing to continue in Phase 2 KOURAGE AKI trial

• CalciMedica cleared to keep dosing Auxora in its Phase 2 KOURAGE trial in Stage 2–3 acute kidney injury with acute hypoxemic respiratory failure.
• FDA review of an amended protocol and interim safety package drew no comments, removing a near-term regulatory overhang on the study.
• Interim safety results have already been submitted to regulators; no new public presentation of results was disclosed.
• The trial had been paused in January following a monitoring committee concern tied to a mortality imbalance; reviews found no evidence of drug-related toxicity.
• Company now expects FDA feedback on the design of a potential pivotal Auxora program in acute pancreatitis in Q3 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. CalciMedica Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: 202606240700PR_NEWS_USPR_____LA90823) on June 24, 2026, and is solely responsible for the information contained therein.