Finland's Faron hammered by surprising pivotal trial flop; CFO Simon Dingemans exits GSK in leadership makeover
→ A pivotal trial disaster has caught Faron Pharmaceuticals’ execs by surprise and crushed its stock. The Finnish biotech reported Tuesday that its lead drug, Traumakine, failed to meet the primary composite endpoint for efficacy in a Phase III trial for acute respiratory distress syndrome (ARDS). Immediately after the announcement, their shares $FARN slid 83% on the London Stock Exchange.
By the numbers, Traumakine actually did a little worse than placebo on all three counts of efficacy, though Faron pointed out that none of the differences were statistically significant. In the 300-person trial, by Day 28, patients treated with Traumakine had a medium of 10 ventilator free days, while the placebo group saw 8.5; all cause mortality at Day 28 was 26.4% those on Traumakine and 23% those given placebo; and mortality at Day 90 was 32.6% in the drug group compared to 31.6% in the placebo arm.
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