The CSL Ltd (ASX: CSL) share price is under pressure on Monday.
In morning trade, the biotechnology company's shares are down 6% to $286.14.
Why is the CSL share price falling?
Investors have been hitting the sell button this morning after CSL released disappointing trial results for its highly anticipated CSL112 product.
The company has been undertaking the Phase 3 AEGIS-II trial evaluating the efficacy and safety of CSL112 compared to placebo in reducing the risk of major adverse cardiovascular events (MACE) in patients following an acute myocardial infarction (AMI).
According to the release, while there were no major safety or tolerability concerns with CSL112, unfortunately, the study did not meet its primary efficacy endpoint of MACE reduction at 90 days.
As a result, CSL revealed that there are no plans for a near-term regulatory filing. Which is a big blow given how analysts have previously estimated that CSL112 could pull in peak sales of US$3 billion per year.
This isn't goodbye
While CSL isn't pushing ahead with a near term regulatory filing, it isn't necessarily saying goodbye to CSL112 just yet.
The company's Head of R&D, Dr Bill Mezzanotte, commented:
Substantial work remains to fully analyse and understand the complete data and then to determine any development path ahead for this asset. We thank all the patients, families, caregivers, and investigators for their support and participation in the AEGIS program.
AEGIS-II is the most ambitious study in our company's history and we are proud of the quality of the study we delivered and the enhanced capabilities we developed to do so. We plan to apply these capabilities as well as our plasma protein platform to future unmet medical need in cardiovascular and metabolic conditions as well as those in our other strategic therapeutic areas.
