Australia’s CSL tumbles after heart attack drug trial falls through By Investing.com
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Investing.com– Shares of Australian pharmaceutical giant CSL Ltd (ASX:) tumbled on Monday after it said that a phase 3 trial for a drug to treat second heart attacks had failed to meet its primary endpoint in efficacy.
CSL shares fell 4.5% to A$291.35, and were among the biggest weights on the broader index, which fell 0.1%. Shares of the pharmaceutical firm were also set for their worst day in four months.
CSL said in an announcement that a phase 3 trial for CSL112 did not meet its primary endpoint of reducing “major adverse cardiovascular events” in the 90 day, high-risk period after an initial heart attack.
The firm said that following the study, there were no plans to pursue a regulatory filing for the drug in the near-term. CSL also said that the CSL112 trial was not expected to have “any material financial impact.”
The study had enrolled over 18,200 patients and covered 49 countries, with CSL calling the study “the most ambitious study” in the company’s history.
“Substantial work remains to fully analyse and understand the complete data and then to determine any development path ahead for this asset,” Bill Mezzanotte, Executive Vice President, Head of R&D at CSL said in a statement.
Mezanotte added that the firm would still leverage some aspects of the AEGIS-II study for finding medical needs in other cardiovascular and metabolic conditions.
The announcement came just a day ahead of CSL’s earnings for the six months to December 31. CSL said it will provide more details on the phase 3 study during an earnings briefing on Tuesday.
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© Reuters
Investing.com– Shares of Australian pharmaceutical giant CSL Ltd (ASX:) tumbled on Monday after it said that a phase 3 trial for a drug to treat second heart attacks had failed to meet its primary endpoint in efficacy.
CSL shares fell 4.5% to A$291.35, and were among the biggest weights on the broader index, which fell 0.1%. Shares of the pharmaceutical firm were also set for their worst day in four months.
CSL said in an announcement that a phase 3 trial for CSL112 did not meet its primary endpoint of reducing “major adverse cardiovascular events” in the 90 day, high-risk period after an initial heart attack.
The firm said that following the study, there were no plans to pursue a regulatory filing for the drug in the near-term. CSL also said that the CSL112 trial was not expected to have “any material financial impact.”
The study had enrolled over 18,200 patients and covered 49 countries, with CSL calling the study “the most ambitious study” in the company’s history.
“Substantial work remains to fully analyse and understand the complete data and then to determine any development path ahead for this asset,” Bill Mezzanotte, Executive Vice President, Head of R&D at CSL said in a statement.
Mezanotte added that the firm would still leverage some aspects of the AEGIS-II study for finding medical needs in other cardiovascular and metabolic conditions.
The announcement came just a day ahead of CSL’s earnings for the six months to December 31. CSL said it will provide more details on the phase 3 study during an earnings briefing on Tuesday.
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