4 days ago · Novo Nordisk A/S: Once-weekly Mim8 is well-tolerated and efficacious in children living with haemophilia A with and without inhibitors. Phase 3 FRONTIER3 interim analysis data presented at EAHAD 2025 showed that 74.3% of children on once-weekly Mim8 prophylaxis experienced zero treated bleeds Bagsværd, Denmark, 7 February 2025 – Novo Nordisk today …

May 13, 2024 · Contingent on regulatory interactions, Novo Nordisk aims to submit Mim8 for the first regulatory approval towards the end of 2024. Data from the phase 3 FRONTIER programme, including FRONTIER 2 will be disclosed at upcoming congresses and in …

Nov 13, 2019 · We describe the development and pre-clinical characterization of Mim8, a novel, next-generation FVIII mimetic human bispecific antibody. Mim8 is a highly potent molecule bridging factor IXa (FIXa) and factor X (FX) in development for subcutaneous treatment of people with HA and HAwI.

3 days ago · Novo Nordisk’s haemophilia A therapy Mim8 stopped bleeding completely in 74.3% of children in a Phase III trial.. The FRONTIER3 trial (NCT05306418) achieved its co-primary endpoints, demonstrating a statistically significant and superior reduction of treated bleeding episodes with both once-weekly and once-monthly Mim8 versus no prophylaxis treatment and …

Nov 15, 2022 · Preclinical data demonstrate that Mim8 is highly potent with an efficacious hemostatic effect. The FRONTIER program aims to expedite Mim8 development, recruiting participants from >30 countries including women, previously untreated patients (PUPs), and patients with mild/moderate disease severity.

Mim8 (denecimig) is a novel activated coagulation factor VIII-mimetic bispecific antibody that assembles with activated coagulation FIX and FX on the platelet membrane surface.

3 days ago · Novo Nordisk expects Mim8 regulatory submission during 2025. Data from the ongoing phase 3 FRONTIER programme will be disclosed at upcoming congresses and in publications in 2025 and 2026.

Aug 23, 2023 · Background: Mim8 (denecimig) is a novel activated coagulation factor VIII-mimetic bispecific antibody that assembles with activated coagulation FIX and FX on the platelet membrane surface.

• Mim8 is a novel drug under development for patients with hemophilia A. • We report the safety, tolerability, pharmacokinetics, and pharmacodynamics of Mim8. • Mim8 was well tolerated, and there were no severe adverse effects from treatment.

3 days ago · Novo Nordisk has bolstered the case for its near-approval hemophilia A drug candidate Mim8, linking the prospect to reductions in treated bleeds in children with the hereditary bleeding disorder.