CalciMedica Inc.
(NASDAQ:CALC) said on Wednesday the U.S.
Food and Drug Administration (FDA) raised no objections to amendments made to its Phase 2 KOURAGE study, allowing the company to continue dosing patients with Auxora in acute kidney injury.
Separately, the clinical-stage biotechnology company announced a private placement expected to generate up to approximately $49 million to support a new pulmonary hypertension-focused strategy.
Read Also: CalciMedica Pauses Kidney Study, Eyes New Trial In Pancreatitis FDA Raises No Questions On Revised KOURAGE Trial The company said the FDA reviewed a protocol amendment and interim safety information related to the Phase 2 KOURAGE trial, which is evaluating Auxora in patients with Stage 2 or Stage 3 acute kidney injury accompanied by acute hypoxemic respiratory failure.
