Novo clears Phase 3 hemophilia A trial, plans to submit application by year’s end

No­vo Nordisk said Mon­day that its in­ves­ti­ga­tion­al treat­ment met both pri­ma­ry end­points in an open-la­bel Phase 3a study in pa­tients with he­mo­phil­ia A, mean­ing pa­tients had few­er bleed­ing episodes.

Fol­low­ing the topline FRON­TIER 2 da­ta dis­clo­sure via a press re­lease, the Dan­ish drug­mak­er’s shares $NVO were up about 3.5%.

No­vo re­vealed on­ly a few head­line da­ta points on the 26-week, 254-pa­tient tri­al, but said it will re­lease more da­ta at “up­com­ing con­gress­es and in pub­li­ca­tions” this year and in 2025. By the end of this year, No­vo said it plans to sub­mit the treat­ment known as Mim8 for its first reg­u­la­to­ry ap­proval.

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