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Novo Nordisk announced that its Phase 3 HIBISCUS trial of etavopivat (an oral pyruvate kinase activator in the same class as mitapivat) met both co-primary endpoints versus placebo: a 27% reduction in annualized vaso-occlusive crisis (VOC) rate and 48.7% of patients achieving a >1 g/dL hemoglobin increase (vs. 7.2% on placebo). It also extended median time to first VOC (38.4 vs. 20.9 weeks) and was well tolerated, with plans for regulatory submission in the second half of 2026. This contrasts with Agios’ earlier mixed RISE UP Phase 3 results for mitapivat in SCD (which improved hemoglobin but missed on VOC rates), intensifying competitive concerns for Agios’ SCD program and follow-on assets. The news, reported after the prior close, drove immediate selling in premarket trading on April 20, according to real-time commentary from analysts including Adam Feuerstein and market reports.
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