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.
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.
CalciMedica paused enrollment in the study in January 2026 after the trial’s Independent Data Monitoring Committee recommended reevaluating the study design because of a mortality imbalance.
According to the company, neither the committee nor an external review identified evidence that Auxora caused toxicity.
Instead, the review found differences in baseline disease severity among patients, prompting revisions to the study protocol.
In March, CalciMedica submitted an amended protocol that refined patient eligibility criteria and modified stratification methods.
The filing also included a detailed safety review of the 107 patients treated before enrollment was halted, including analyses of deaths and serious adverse events.
The company said the serious adverse events observed aligned with previous clinical experience with Auxora and did not appear to be related to the drug.
CalciMedica noted that the KOURAGE trial was never placed on clinical hold and that the enrollment pause was voluntary.
Company Awaits Pancreatitis Program Feedback
Looking ahead, CalciMedica said it expects FDA feedback in the third quarter of 2026 regarding 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 disclosed that it entered into a definitive securities purchase agreement with healthcare investors that could provide up to approximately $49 million in gross proceeds.
The proceeds will primarily support a focused pulmonary hypertension strategy centered on the company’s CRAC channel inhibition platform.
CalciMedica plans to initiate a Phase 1b proof-of-concept study evaluating intravenous Auxora in patients with pulmonary arterial hypertension, with data expected in mid-2027.
The company said findings from that study could help validate CRAC channel inhibition in pulmonary hypertension and reduce development risk for CM5480, its oral CRAC channel inhibitor candidate intended for chronic treatment.
Funds will also support IND-enabling activities 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 Benzinga Pro data.
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