CSL Shares Tumble as Phase 3 Trial for Heart Attack Drug Fails
Shares of Australian pharmaceutical giant CSL Ltd (ASX:) dropped 4.5% on Monday after the company announced that a phase 3 trial for its drug, CSL112, failed to meet its primary efficacy endpoint. The trial aimed to determine the drug’s effectiveness in reducing “major adverse cardiovascular events” during the 90-day, high-risk period following an initial heart attack.
The disappointing results sent CSL shares tumbling to A$291.35 and weighed on the broader market, which fell by 0.1%. This decline marks the worst day for CSL shares in four months. Despite the setback, CSL confirmed that the trial’s results were not expected to have any material financial impact.
The phase 3 trial, which involved over 18,200 patients across 49 countries, was hailed as “the most ambitious study” in CSL’s history. However, with the drug failing to meet its primary endpoint, CSL stated that it had no plans to pursue regulatory filing for CSL112 in the near future.
Bill Mezzanotte, Executive Vice President and Head of R&D at CSL, expressed that substantial analysis was still required to determine the drug’s future development path. Mezzanotte also emphasized that the company would continue to leverage the findings from the AEGIS-II study to address medical needs in other cardiovascular and metabolic conditions.
The announcement of the trial’s failure came just one day ahead of CSL’s earnings report for the six months ending on December 31. CSL plans to provide further details on the phase 3 study during an earnings briefing on Tuesday. Investors are eager to gain insight into how this setback will impact CSL’s financial performance and future prospects.
Analyst comment
Negative news. Analyst: CSL shares will likely continue to face downward pressure as investors digest the disappointment of the failed phase 3 trial. The company’s earnings briefing will provide more clarity on the financial impact and future prospects.
