Votoplam - (PIVOT-HD)

April 28, 2026: Novartis Q1 2026 investor presentation highlighted multiple pipeline/regulatory catalysts and an M&A close. Pipeline highlights included: Rhapsido® (remibrutinib) EC approval in chronic spontaneous urticaria (CSU) in April; Phase III results in chronic inducible urticaria (CIndU) with significantly higher complete response rates vs placebo at week 12 and favorable tolerability; FDA approval of symptomatic dermographism (SD) targeted, with FDA submission for cold and cholinergic urticaria planned in H2 2026. Ianalumab received FDA Breakthrough Therapy Designation and priority review in Sjögren’s disease, with US/EU/CN/JP submissions made in Q1. Cosentyx® received FDA approval (Mar 13, 2026) for pediatric hidradenitis suppurativa (HS); polymyalgia rheumatica (PMR) submissions were completed in US/EU/JP with FDA approval expected in H2. Fabhalta® (iptacopan) reported positive Phase III 24‑month IgA nephropathy (APPLAUSE‑IgAN) results (49.3% slowing in kidney function decline vs placebo; 43% reduction in progression to kidney failure) and is under FDA priority review for traditional approval. Vanrafia (atrasentan) Phase III ALIGN topline supported slowing kidney function decline; Novartis plans FDA/EMA submissions in H1 2026 and expects full data at an upcoming conference. Key upcoming readouts: pelacarsen CV outcomes (Lp(a)HORIZON) in H2 2026; remibrutinib MS Phase III (REMODEL-1/-2) in H2 2026; del-desiran (DM1) Phase III (HARBOR) in H2 2026; ianalumab 1L ITP Phase III in H2 2026; ianalumab wAIHA Phase III missed its primary endpoint in April. Business: acquisition of Avidity Biosciences closed Feb 27, 2026; Novartis expects an FDA submission for del-zota (DMD) in H1 and a del-desiran Phase III readout in H2.