CalciMedica Announces Discontinuation of Phase 2 KOURAGE Trial in AKI Following Independent Data Monitoring Committee Recommendation

Rhea-AI Summary

CalciMedica (Nasdaq: CALC) has discontinued the Phase 2 KOURAGE trial of Auxora in Stage 2–3 acute kidney injury (AKI) with associated acute hypoxemic respiratory failure after an Independent Data Monitoring Committee (IDMC) recommended reevaluation for a safety concern related to study design and enrollment criteria.

The company said no deaths were judged related to study drug and no serious adverse events required expedited FDA reporting. CalciMedica will review unblinded data, assess baseline and treatment factors, notify the FDA, complete 90-day follow-up for enrolled patients, and consider modified future AKI trials while progressing other programs including a pivotal acute pancreatitis trial planning in H1 2026 and CM5480 development.

Positive

• No deaths judged related to Auxora or placebo in KOURAGE
• No serious adverse events met expedited FDA reporting criteria
• Company will conduct a comprehensive unblinded data review to guide next steps
• Plans to complete full 90-day follow-up for enrolled patients

Negative

• Phase 2 KOURAGE trial discontinued after IDMC safety recommendation
• IDMC-identified safety concern requires reevaluation of enrollment criteria
• Discontinuation delays clinical assessment of Auxora in AKI
• Future AKI trial design remains uncertain pending data analysis

News Market Reaction – CALC

-75.59% 20.0x vol

35 alerts

-75.59% Session close to close

-68.5% Trough in 55 min

$73.78M Market Cap

20.0x Rel. Volume

In the Jan 28 session, CALC declined 75.59%, reflecting a significant negative market reaction. Argus tracked a trough of -68.5% from its starting point during tracking. Our momentum scanner triggered 35 alerts that day, indicating elevated trading interest and price volatility. Trading volume was exceptionally heavy at 20.0x the daily average, suggesting significant selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock dropped -75.6% in the session following this news. A negative reaction despite the absence...

Analysis

The stock dropped -75.6% in the session following this news. A negative reaction despite the absence of drug‑related deaths or expedited FDA safety reports fits CALC’s pattern of sharp swings on clinical news. The loss of the KOURAGE AKI trial as a near‑term catalyst contrasts with prior positive updates that sometimes saw large downside moves of over 30%. Existing liquidity pressures and ATM usage could further sensitize the stock to disappointing clinical developments.

Key Figures

Phase: Phase 2 AKI stage: Stage 2 or Stage 3 Patients treated: more than 350 patients +4 more

7 metrics

Phase Phase 2 KOURAGE Auxora AKI trial

AKI stage Stage 2 or Stage 3 Patient population in KOURAGE trial

Patients treated more than 350 patients Critically ill patients treated with Auxora in completed trials

Follow-up duration 90-day follow-up Planned follow-up period for KOURAGE trial patients

Phase 2b CARPO Phase 2b CARPO trial in acute pancreatitis

Phase 2 CARDEA Phase 2 CARDEA trial in severe COVID-19 pneumonia

Pivotal AP trial timing first half of 2026 Expected timing to finalize pivotal acute pancreatitis trial design, pending FDA feedback

Previous Clinical trial Reports

5 past events · Latest: Jun 25 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jun 25	KOURAGE design paper	Positive	-4.8%	Publication of KOURAGE trial design with promising AKI preclinical and CARDEA data.
Jul 09	KOURAGE first enrollment	Positive	+4.5%	First patient enrolled in Phase 2 KOURAGE AKI trial with AHRF.
Jun 27	CARPO topline data	Positive	-32.4%	Positive Phase 2b CARPO pancreatitis data with significant clinical benefits.
Apr 24	CARPO fully enrolled	Neutral	+19.6%	Announcement of last patient enrolled in Phase 2b CARPO pancreatitis trial.
Mar 13	AKI preclinical data	Neutral	-3.6%	Presentation of preclinical Auxora data in acute kidney injury at a conference.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Clinical-trial news for CALC has produced large, often volatile moves, with several instances where price reaction diverged from seemingly positive clinical updates.

Recent Company History

Over the past two years, CalciMedica has repeatedly highlighted Auxora’s clinical development. Prior clinical-trial news included design and rationale of the Phase 2 KOURAGE AKI trial (Jun 25, 2025), first patient enrollment (Jul 9, 2024), and positive topline data from the Phase 2b CARPO pancreatitis trial (Jun 27, 2024). Those events produced both sharp gains and declines, underscoring inconsistent trading responses. Today’s discontinuation of KOURAGE marks a setback within the same clinical program previously emphasized as a key value driver.

Key Terms

acute kidney injury, acute hypoxemic respiratory failure, Independent Data Monitoring Committee, serious adverse events, +4 more

8 terms

acute kidney injury medical

"Phase 2 KOURAGE clinical trial evaluating Auxora™ in patients with Stage 2 or Stage 3 acute kidney injury (AKI)"

A sudden decline in how well the kidneys remove waste and balance fluids, often developing over hours or days; think of it like an engine that abruptly loses power and can’t filter efficiently. It matters to investors because it can drive higher medical costs, alter clinical trial results, trigger regulatory scrutiny, lead to drug label changes or recalls, and affect revenue and liability for healthcare and life sciences companies.

acute hypoxemic respiratory failure medical

"acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF)"

A sudden, severe condition in which the lungs cannot deliver enough oxygen to the bloodstream, causing dangerously low blood oxygen levels and often requiring supplemental oxygen, a breathing tube, or intensive care. Think of it like an engine starving for air: organs struggle to work without enough oxygen. Investors track it because its frequency, treatment options, and outcomes drive demand for drugs, ventilators, hospital services, and clinical trial priorities.

Independent Data Monitoring Committee medical

"The decision follows a recommendation from the trial's Independent Data Monitoring Committee (IDMC)."

A panel of independent medical, statistical and ethical experts who review ongoing clinical trial data to judge participant safety, study integrity and whether the trial should continue, change or stop. Like impartial referees or safety inspectors, their decisions can speed, delay or halt a drug’s development and therefore materially affect a company’s timelines, regulatory chances and investment risk.

serious adverse events medical

"no serious adverse events met the criteria for expedited reporting to the U.S. Food and Drug Administration"

Serious adverse events are significant problems or negative outcomes that occur during a medical treatment or clinical trial, such as severe side effects, hospitalizations, or life-threatening conditions. They matter to investors because such events can impact a company's reputation, lead to regulatory scrutiny, or delay the development of new products, ultimately affecting the company’s financial performance.

U.S. Food and Drug Administration regulatory

"no serious adverse events met the criteria for expedited reporting to the U.S. Food and Drug Administration (FDA)."

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

Phase 2b medical

"including the Phase 2b CARPO trial in acute pancreatitis (AP)"

Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.

pivotal trial medical

"finalizing the design of a pivotal trial in AP, pending FDA feedback"

A pivotal trial is a key test of a new medicine or treatment to see if it works and is safe enough to be approved by health authorities. It's like a final exam for a new product, and passing it is essential for bringing the treatment to the public.

pulmonary arterial hypertension medical

"CM5480, as a potential first-in-class, differentiated therapy for pulmonary arterial hypertension."

Pulmonary arterial hypertension is a progressive medical condition in which the arteries that carry blood from the heart to the lungs become narrowed or stiff, causing high pressure in the lung circulation and extra strain on the heart — like a pump working against clogged pipes. For investors, it matters because the condition defines the need, market size, clinical trial design, regulatory hurdles and potential revenue or risk for companies developing drugs, devices or diagnostics to treat or manage it.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Safety concern warrants reevaluation of study design, including enrollment criteria

Potential future trial with Auxora™ in AKI to be evaluated after data analysis

LA JOLLA, Calif., Jan. 28, 2026 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, today announced the discontinuation of its Phase 2 KOURAGE clinical trial evaluating Auxora™ in patients with Stage 2 or Stage 3 acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF), a population characterized by high mortality and a lack of approved therapies. The decision follows a recommendation from the trial's Independent Data Monitoring Committee (IDMC).

During a prescheduled interim data review, the IDMC identified a safety concern that, in its view, warrants reevaluation of the study design, particularly with respect to patient enrollment criteria. There were no deaths in the trial that were assessed by investigators or CalciMedica as being related to study drug (either Auxora or placebo). In addition, no serious adverse events met the criteria for expedited reporting to the U.S. Food and Drug Administration (FDA). Based on the IDMC's recommendation, the Company has discontinued the trial and plans to perform a comprehensive review of the unblinded clinical data.

The Company will assess the impact of baseline characteristics, disease severity, concomitant therapies, and other factors on patient outcomes. These analyses are expected to inform how future clinical evaluation of Auxora in AKI may proceed.

"Based on the IDMC's feedback, we will review the unblinded KOURAGE data and explore modifications to the trial design, particularly patient enrollment criteria, that may support further clinical testing of Auxora in patients with AKI," said Rachel Leheny, Ph.D., CEO of CalciMedica. "To date, no treatment-related safety concern has been observed across more than 350 critically ill patients treated with Auxora in completed clinical trials, including the Phase 2b CARPO trial in acute pancreatitis (AP) and the Phase 2 CARDEA trial in severe COVID-19 pneumonia. We remain optimistic about Auxora's potential in acute inflammatory illnesses and look forward to finalizing the design of a pivotal trial in AP, pending FDA feedback, in the first half of 2026, while also advancing a second CRAC channel inhibitor, CM5480, as a potential first-in-class, differentiated therapy for pulmonary arterial hypertension."

The Company has notified the FDA about the trial discontinuation and will work with investigators to ensure all patients currently enrolled in the trial complete the full 90-day follow-up.

About CalciMedica
CalciMedica is a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for inflammatory and immunologic diseases. CalciMedica's proprietary technology targets the inhibition of CRAC channels to modulate the immune response and protect against tissue cell injury, with the potential to provide therapeutic benefits in in serious and life-threatening conditions with high unmet need. CalciMedica's lead product candidate, Auxora™, has demonstrated positive clinical results in multiple completed efficacy clinical trials. The Company has reported data from a Phase 2b trial (CARPO; NCT04681066) evaluating Auxora in patients with acute pancreatitis (AP) and accompanying systemic inflammatory response syndrome (SIRS), as well as from a Phase 2 trial (CARDEA; NCT04345614) in patients with severe COVID-19 pneumonia. In addition, CalciMedica is advancing CM5480 as a potential therapy for pulmonary arterial hypertension (PAH), supported by preclinical data demonstrating effects on pulmonary vascular remodeling and right ventricular function. For more information, please visit www.calcimedica.com.

Forward-Looking Statements
This communication contains forward-looking statements which include, but are not limited to CalciMedica's planned and ongoing clinical trials and the timing, design, expected patient enrollment thereof and the expected timing for updates; statements regarding the safety and efficacy of its product candidates; statements regarding the planned analysis of the unblinded KOURAGE dataset, including the timing of such analysis and whether such analysis will inform future trial parameters; and the potential of CalciMedica's proprietary technology to provide therapeutic benefits in PAH and other acute and chronic inflammatory and immunologic diseases such as AKI and AP. These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. CalciMedica's expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks, and changes in circumstances, including but not limited to risks and uncertainties related to: the impact of fluctuations in global financial markets on CalciMedica's business and the actions it may take in response thereto; CalciMedica's ability to execute its plans and strategies; the ability to obtain and maintain regulatory approval for Auxora; results from clinical trials or preclinical studies may not be indicative of results that may be observed in the future; potential safety and other complications from Auxora; the scope, progress and expansion of developing and commercializing Auxora; the size and growth of the market therefor and the rate and degree of market acceptance thereof; economic, business, competitive, and/or regulatory factors affecting the business of CalciMedica generally; CalciMedica's ability to protect its intellectual property position; the impact of government laws and regulations; and CalciMedica's financial position and need for additional capital. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" in CalciMedica's Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the Securities and Exchange Commission (SEC) on November 12, 2025, and elsewhere in CalciMedica's subsequent reports on Form 10-K, Form 10-Q or Form 8-K filed with the SEC from time to time and available at www.sec.gov. These documents can be accessed on CalciMedica's web page at ir.calcimedica.com/financials-filings/sec-filings. The forward-looking statements contained herein are made as of the date hereof, and CalciMedica undertakes no obligation to update them after this date, except as required by law.

Contact Information
Kevin Murphy
calcimedica@argotpartners.com
(212) 600-1902

View original content to download multimedia:https://www.prnewswire.com/news-releases/calcimedica-announces-discontinuation-of-phase-2-kourage-trial-in-aki-following-independent-data-monitoring-committee-recommendation-302671925.html

SOURCE CalciMedica, Inc.

FAQ

Why did CalciMedica (CALC) discontinue the Phase 2 KOURAGE trial on January 28, 2026?

The trial was discontinued after the Independent Data Monitoring Committee recommended reevaluation due to a safety concern. According to the company, the IDMC cited issues warranting changes to study design, particularly patient enrollment criteria, prompting a pause and comprehensive unblinded data review.

Were any deaths or reportable serious adverse events linked to Auxora in the KOURAGE trial (CALC)?

No deaths were assessed as related to Auxora or placebo in KOURAGE, and no SAEs met expedited FDA reporting criteria. According to the company, investigators judged no treatment-related deaths and the company notified the FDA of the discontinuation.

What will CalciMedica (CALC) do next after discontinuing the KOURAGE AKI trial?

CalciMedica will perform a comprehensive review of unblinded data and analyze baseline and treatment factors. According to the company, these analyses will inform enrollment criteria and potential modifications for any future Auxora AKI trials.

Will patients enrolled in the KOURAGE trial still be followed after the discontinuation of CALC's study?

Yes, all enrolled patients will complete the full 90-day follow-up period under investigator oversight. According to the company, investigators will ensure completion of follow-up while the company analyzes unblinded clinical data and informs regulators.

Does the KOURAGE discontinuation affect CalciMedica's other programs like the AP pivotal trial or CM5480?

CalciMedica said the KOURAGE pause is specific to AKI and they remain focused on other programs. According to the company, they expect to finalize a pivotal acute pancreatitis trial design in H1 2026 and continue developing CM5480 for pulmonary arterial hypertension.