CalciMedica Halts Auxora Clinical Trial Due to Safety Concerns
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 15h ago
0mins
Source: PRnewswire
- Trial Suspension: CalciMedica has announced the suspension of its Phase 2 KOURAGE clinical trial for Auxora™ in acute kidney injury patients due to safety concerns raised by the Independent Data Monitoring Committee, which may impact future clinical evaluations.
- Data Analysis Plan: The company plans to conduct a comprehensive review of unblinded clinical data to assess the impact of baseline characteristics, disease severity, and other factors on patient outcomes, guiding future clinical testing of Auxora in AKI.
- Safety Assessment Results: No deaths related to Auxora or placebo were reported in the trial, and no serious adverse events met the criteria for expedited reporting to the FDA, indicating good safety for Auxora in over 350 critically ill patients.
- Future Trial Outlook: CalciMedica aims to finalize the pivotal trial design for Auxora in acute pancreatitis in the first half of 2026, pending FDA feedback, while also advancing CM5480 as a potential treatment for pulmonary arterial hypertension.
Analyst Views on CALC
Wall Street analysts forecast CALC stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for CALC is 20.00 USD with a low forecast of 20.00 USD and a high forecast of 20.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 5.120
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20.00
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20.00
High
20.00
Current: 5.120
Low
20.00
Averages
20.00
High
20.00
About CALC
CalciMedica, Inc. is a clinical-stage biopharmaceutical company. The Company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for inflammatory and immunologic diseases. The Company's technology targets the inhibition of CRAC channels to modulate the immune response and protect against tissue cell injury. Its lead product candidate is Auxora, a potent and selective intravenous formulated small molecule CRAC channel inhibitor containing the active compound zegocractin (formerly referred to as CM4620) that, in animal models, reduced acute epithelial and/or endothelial cell injury and inflammation in organs, such as the pancreas, lungs and kidneys. The Company is conducting a Phase IIb trial (called CARPO) for acute pancreatitis (AP) with systemic inflammatory response syndrome (SIRS), as well as supporting the ongoing Phase I/II asparaginase-induced pancreatic toxicity (AIPT) study (called CRSPA).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
