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$NVO has published new Phase 3b results for denecimig, its experimental treatment for hemophilia A. In the 26-week FRONTIER5 study, 61 people switched directly from the existing treatment emicizumab to denecimig without having to wait between treatments or take an initial loading dose. The switch was well tolerated, with no unexpected safety concerns and no blood clotting events. Patients also strongly preferred Novo’s pen injector: • 98.3% said it was easy or very easy to use • 94.9% found it easier than their previous treatment method • 96.6% preferred the pen over their previous device Denecimig is currently under FDA review and could offer patients dosing options ranging from once weekly to once monthly. Link: https://t.co/f2UEQNrzdc #stocks #Investing

🇸🇦🩸 Saudi Arabia leads a new milestone in hemophilia A care! 1️⃣ 🌍 World-first approval The Saudi Food & Drug Authority has announced the world’s first registration of denecimig (Mim8; Frehemgo) for routine prevention of bleeding episodes in hemophilia A. ✅ Previously designated under the SFDA’s Promising Drugs program ✅ Evaluated for efficacy, safety and quality ✅ Adds another subcutaneous prophylaxis option 📢 Credit: SFDA announcement and infographic. 2️⃣ 🧬 How does denecimig work? Denecimig is a bispecific antibody that mimics activated factor VIII (FVIIIa). 🔗 Brings FIXa and FX together ⚙️ Facilitates FX activation and downstream thrombin generation 🩸 Supports clot formation despite FVIII deficiency Its activity does not depend on replacing FVIII itself, allowing use in hemophilia A with or without FVIII inhibitors. FRONTIER2 publication⁠ 3️⃣ 💉 Administration The SFDA announcement describes subcutaneous administration: 📅 Once weekly 📅 Every 2 weeks 📅 Once monthly The regimen depends on body weight and the prescribed schedule. 4️⃣ 🔬 Pivotal evidence: FRONTIER2 Phase 3, open-label, randomized study in adolescents and adults with hemophilia A, with or without inhibitors. 👥 254 participants aged ≥12 years ⏳ 26-week main treatment phase 💉 Weekly or monthly subcutaneous denecimig 🎯 Primary endpoint: annualized rate of treated bleeding events Comparisons included on-demand treatment and patients’ prospectively recorded prior clotting-factor prophylaxis. Mancuso et al., NEJM 2026⁠ 5️⃣ 📉 Bleeding outcomes In the cohort previously receiving on-demand treatment, estimated treated annualized bleeding rates were: 💉 Weekly denecimig: 0.57 💉 Monthly denecimig: 0.20 🩸 Continued on-demand treatment: 15.76 These correspond to approximately 96% and 99% fewer treated bleeds, respectively. 🧠 These are annualized rates estimated during trial follow-up; they do not mean every patient remained bleed-free. FRONTIER2 results⁠ 6️⃣ 🛡️ Safety The pivotal publication reported: ✅ No thromboembolic events ✅ No clinical evidence of neutralizing anti-denecimig antibodies However, absence of events in a trial does not establish zero long-term risk. FRONTIER2 safety results⁠ The SFDA infographic lists potential adverse effects: 🔴 Injection-site redness 🤏 Injection-site itching 🌡️ Fever 🤕 Headache 🤧 Upper respiratory tract infections 7️⃣ 🧪 Essential laboratory pearl Denecimig can interfere with: ⚠️ aPTT-based tests ⚠️ One-stage FVIII activity assays ⚠️ Some chromogenic FVIII assays A shortened or normal aPTT during treatment should not be interpreted as proof of normal endogenous FVIII activity. 📞 Inform the coagulation laboratory and use assays validated for samples containing denecimig. Bowyer et al., Haemophilia⁠ 8️⃣ 🎯 How should we interpret this advance? 🇸🇦 A significant regulatory milestone for Saudi Arabia 💉 More flexibility in prophylaxis schedules 🩸 Strong evidence for reducing treated bleeding episodes Comparisons across separate trials cannot establish superiority over emicizumab or other modern prophylactic therapies. Treatment selection still requires the approved label, bleeding history, patient preference and specialist assessment. 📚 Key scientific references: 🔗 Mancuso et al. — Mim8 prophylaxis in hemophilia A, NEJM 2026⁠ 🔗 Bowyer et al. — Denecimig interference with coagulation assays⁠ #Hemophilia #HemophiliaA #Denecimig #Hematology #SFDA #SaudiArabia

📢 Exciting long-term data from innovaTV 205/ENGOT-cx8/GOG-3024 show durable benefit with tisotumab vedotin–based combinations in recurrent/metastatic cervical cancer. 🎗️ With 5+ years of follow-up, TV + carboplatin + pembrolizumab demonstrated a 65.8% response rate and median OS of 28 months, with no new safety signals reported. 🚀 Promising evidence supporting the continued evolution of ADC + immunotherapy combinations in cervical cancer. #GynOnc #CervicalCancer #ADC #Immunotherapy #SGO2026