On Friday, CalciMedica, listed on NASDAQ as NASDAQ:CALC, maintained its Buy rating and a price target of $20.00, following the announcement of positive topline data from its Phase 2b study of Auxora for the treatment of acute pancreatitis (AP). The study showed promising results for Auxora, a small molecule CRAC channel inhibitor, which could potentially address the high unmet need for AP treatments, characterized by long hospital stays and the absence of approved drugs.
The global, randomized, double-blind, placebo-controlled, dose-ranging trial aimed to establish the dose-response and efficacy of Auxora in AP patients with accompanying systemic inflammatory response syndrome (SIRS). The study reached its enrollment goal with 216 patients, who were divided into four groups to receive varying doses of Auxora or a placebo intravenously every 24 hours for three doses, followed by a 30-day observation period.
Patients in the study were stratified by baseline hematocrit to assess the efficacy in a hyper-inflamed subgroup. The most significant clinical benefit was observed in patients with hyper-inflammatory AP. The primary objective of the study was met, demonstrating a statistically significant dose response with up to a 43.6% relative reduction, which equates to a 2.1-day improvement, in median time to solid food tolerance compared to placebo in hyper-inflamed patients.
Additionally, the study found a statistically significant dose response with up to a 61.7% reduction in severe organ failure across all patients compared to placebo. Remarkably, there was also up to a 100% reduction in hospital stays exceeding 21 days. These findings position Auxora as a potentially important treatment for AP, paving the way for its advancement in clinical development.
In other recent news, biopharmaceutical company CalciMedica reported positive outcomes from its Phase 2b CARPO trial of Auxora in patients with acute pancreatitis and systemic inflammatory response syndrome. The trial demonstrated a significant reduction in time to solid food tolerance and severe organ failure versus placebo.
However, Jones Trading has adjusted its price target on shares of CalciMedica, reducing it to $15.00 from the previous $22.00 while maintaining a Buy rating, following mixed results from the trial. Analyst firm Oppenheimer maintained its Outperform rating on CalciMedica, emphasizing the commercial potential of Auxora with a price target of $14.00.
CalciMedica is also making progress in its clinical studies of Auxora for treating acute kidney injury, with the Phase 2 KOURAGE trial set to begin enrollment soon. These recent developments highlight CalciMedica's ongoing commitment to advancing its clinical trials and developing effective treatments for acute inflammatory and immunologic illnesses. As the company moves forward, it continues to receive positive feedback from analysts and maintains a strong focus on its research and development efforts.
InvestingPro Insights
CalciMedica, known in the market by its ticker NASDAQ:CALC, is navigating through a critical phase as it progresses with its promising treatment, Auxora. The latest data from InvestingPro sheds light on the financial health and market sentiment surrounding the company. With a market capitalization of $50.09 million, the company's financial position reflects a challenging environment, underscored by an adjusted P/E ratio for the last twelve months as of Q1 2024 at -2.03, signaling investor concerns over profitability.
InvestingPro Tips suggest that CalciMedica holds more cash than debt, a reassuring sign of financial stability (Tip #0), and that its liquid assets exceed its short-term obligations (Tip #7), providing some cushioning in the volatile market. However, the stock has experienced a significant decline over the last week, with a price total return of -41.12% (InvestingPro Data), which may indicate a reaction to broader market trends or company-specific events.
For investors looking to gain deeper insights into CalciMedica and other investment opportunities, InvestingPro offers additional tips on its platform. By using the coupon code PRONEWS24, readers can get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, unlocking further valuable financial analysis and market trends. Visit InvestingPro for a comprehensive set of tips, with the number of additional tips available for CalciMedica listed on the platform.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.