CalciMedica Inc. (CalciMedica (CALC)) got some good news Wednesday: the FDA has no objections to the changes the company made to its Phase 2 KOURAGE study, so it can start dosing patients with Auxora again in acute kidney injury.

Separately, the clinical-stage biotech announced a private placement that could bring in up to about $49 million to support a new focus on pulmonary hypertension.

FDA Gives the Thumbs Up on Revised KOURAGE Trial

The company said the FDA reviewed a protocol amendment and interim safety data for the KOURAGE trial, which is testing Auxora in patients with Stage 2 or Stage 3 acute kidney injury along with acute hypoxemic respiratory failure.

CalciMedica voluntarily paused enrollment back in January 2026 after the trial's Independent Data Monitoring Committee recommended rethinking the study design because of a mortality imbalance. But here's the key: neither the committee nor an external review found any evidence that Auxora itself was toxic. Instead, the issue was that patients in the study had different levels of disease severity at the start, which skewed the results. That led to revisions in the protocol.

In March, CalciMedica submitted an amended protocol that tightened up patient eligibility criteria and changed how patients were stratified. The filing also included a detailed safety review of the 107 patients already treated before the pause, covering deaths and serious adverse events. The company said those serious adverse events were consistent with what's been seen before with Auxora and didn't seem to be related to the drug. Also worth noting: the KOURAGE trial was never on clinical hold—the pause was voluntary.

Waiting on Pancreatitis Program Feedback

Looking ahead, CalciMedica expects to hear back from the FDA in the third quarter of 2026 about the design of a potential pivotal development program for Auxora in acute pancreatitis.

Private Placement to Fund Pulmonary Hypertension Push

In a separate announcement, CalciMedica said it signed a securities purchase agreement with healthcare investors that could bring in up to roughly $49 million in gross proceeds. The money will mainly go toward a focused pulmonary hypertension strategy built around the company's CRAC channel inhibition platform.

CalciMedica plans to start a Phase 1b proof-of-concept study testing intravenous Auxora in patients with pulmonary arterial hypertension, with data expected by mid-2027. The company says results from that study could help validate CRAC channel inhibition in pulmonary hypertension and reduce the risk for CM5480, its oral CRAC channel inhibitor candidate meant for chronic treatment. Funds will also support IND-enabling work for CM5480 and general corporate purposes.

CALC Stock Price Activity: CalciMedica shares were down 1.20% at $0.79 during premarket trading on Wednesday, according to market data.