Novo’s late-stage sickle cell win piles pressure on competitors

Novo Nordisk’s etavopivat elicited a 27% drop in vaso-occlusive crises and 48.7% hemoglobin response after 24 weeks, creating “separation amongst PK class candidates,” Truist analysts said on Monday. Novo plans to seek FDA approval in the back half of 2026.

Novo Nordisk’s drug candidate for sickle cell disease significantly reduced severe pain crises in a Phase 3 study, opening the path for a regulatory submission later this year—and putting pressure on other drugmakers in this space.

The readout “creates separation amongst PK class candidates,” analysts at Truist Securities wrote to investors on Monday.