$IRON Reduction in whole-blood metal-free PPIX from baseline (-41.4% vs. placebo, p<0.0001) Increase in average monthly total time in light without pain during month 6 (+12.2 hours vs. placebo, p=0.0010)
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+12.2 hours a month of pain-free time in light vs placebo is the number EPP patients will feel. The 41% PPIX drop is the mechanism behind it. The only approved therapy is a surgically implanted hormone. A once-daily pill is a real shift. Dizziness at 50% is the label question.
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This is the CRL do-over. Disc aligned with FDA in a Type A meeting that a positive APOLLO could support the CRL response. It hit every primary and secondary endpoint. NDA resubmission by end of 2026, decision expected mid-2027.
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All endpoints hit in APOLLO is a big deal for EPP patients. @mozlyxy has been covering $IRON closely — worth a follow.
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$IRON三期数据全中太强了，EPP终于有希望。想跟进这类临床催化剂可以看下 @fotsguy
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