Mim8 - (FRONTIER5)

May 6, 2026: Novo Nordisk (NOVO B; NVO) Q1 2026 investor presentation highlighted multiple regulatory and clinical catalysts across obesity, diabetes and rare disease.

Obesity/weight management:

• Wegovy® (semaglutide) 7.2 mg (Wegovy® HD): FDA approval; also notes Wegovy® 7.2 mg approved in the US & EU.
• Oral semaglutide 25 mg (Wegovy® pill): approved in the US and submitted in the EU; OASIS 4 showed 16.6% weight loss at 64 weeks (trial product estimand).
• CagriSema (cagrilintide 2.4 mg + semaglutide 2.4 mg): REDEFINE 1 achieved 22.7% mean weight loss at 68 weeks; US decision on obesity submission expected in Q4 2026; high-dose phase 3b initiation expected Q2 2026.
• Zenagamtide (amycretin): AMAZE phase 3 programme initiated/starting (obesity); additional phase 3 (T2D; AMBITION) planned for H2 2026.

Rare disease:

• Etavopivat (sickle cell disease): HIBISCUS phase 3 completed and met both co-primary endpoints (27% annualised VOC reduction; 48.7% Hb response >1 g/dL at week 24); first regulatory filing expected Q4 2026; HIBISCUS2 phase 3b ongoing.
• Denecimig (Mim8; haemophilia A): FRONTIER 2 showed superior reduction in treated bleeds; submitted for approval in the EU and US.

Diabetes/cardiometabolic:

• Awiqli® (T2D): approved in the US.
• UBT251 (tri-agonist): China phase 2 completed (up to 19.7% weight loss in obesity); global phase 2 in T2D expected to start Q2 2026; additional data planned at ADA June 2026; global obesity data expected in 2027.
• Upcoming regulatory milestones listed include: oral semaglutide 25 mg US decision (Q4 2026), Wegovy® (FlexTouch) US decision (Q3 2026), and multiple EU decisions (Q3–Q4 2026).