Novartis opened 2026 with a mixed first quarter: net sales declined 5% at constant currency and core operating income fell 14%, as U.S. generic erosion and pricing headwinds more than offset robust volume growth and strong contributions from priority brands. Kisqali, Pluvicto, Kesimpta, Scemblix, Leqvio, and Fabhalta all delivered double- to triple‑digit growth rates on a constant-currency basis, while Cosentyx remained broadly stable globally. The company reaffirmed full‑year guidance for low single‑digit net sales growth and a low single‑digit decline in core operating income. On the innovation front, Novartis completed the acquisition of Avidity Biosciences, secured a positive CHMP opinion for remibrutinib in chronic spontaneous urticaria, gained FDA priority review and Breakthrough Therapy designation for ianalumab in Sjögren’s disease, won a pediatric hidradenitis suppurativa approval for Cosentyx, reported compelling Phase 3 and regulatory momentum for Fabhalta in IgA nephropathy, and withdrew its EU application for pre‑chemotherapy Pluvicto in mCRPC following CHMP feedback.
The strategic throughline is clear: Novartis is trading near‑term revenue friction for a higher‑value, specialty‑heavy mix anchored by oncology, immunology, and nephrology, while placing deliberate platform bets in radioligand therapy and xRNA. The central question is whether this mix shift—and the cadence of late‑stage readouts and approvals—can outpace loss‑of‑exclusivity pressure and increasingly divergent regional regulatory expectations, particularly in Europe for radiopharmaceuticals.
This matters now because the next 12 to 18 months could reset treatment norms across several high‑burden conditions. For patients, remibrutinib’s trajectory across chronic urticaria, inducible subtypes, and a planned food allergy program points to an oral, rapid‑onset option in settings long dominated by antihistamines and biologics. Ianalumab offers the first credible shot at disease activity reduction in Sjögren’s with the urgency of priority review, potentially redefining a largely symptomatic care pathway. Fabhalta’s IgA nephropathy data and priority review elevate complement inhibition as a disease‑modifying cornerstone, while atrasentan (Vanrafia) provides Novartis with an endothelin‑pathway counterweight, signaling an intent to own the nephrology treatment continuum. For HCPs, these shifts demand new diagnostic workflows, earlier specialty referral patterns, and careful benefit–risk communication as oral small molecules push into spaces historically led by injectables. For payers, the clustering of high‑value launches will force rapid assessments of step therapy, biomarker use, and real‑world outcomes commitments.
Commercially, the quarter exposed the industry’s prevailing tension: 13 percentage points of volume growth were neutralized by 14 points of generic competition and further diluted by U.S. pricing dynamics, even as currency added a tailwind. China demonstrated its pull with Leqvio’s accelerated uptake following NRDL inclusion, underscoring why big pharma growth theses increasingly hinge on a U.S.–China axis, complemented by Germany and Japan. The Pluvicto setback in the EU, despite approvals in the U.S., Japan, and China for the pre‑chemotherapy setting, highlights how evidence standards for radioligands remain fragmented; Medical Affairs will need to lean into region‑specific data packages and pragmatic studies to harmonize adoption.
The competitive board is also shifting. In breast cancer, Novartis is reinforcing Kisqali’s momentum with a pan‑mutant selective PI3Kα program, positioning for combination strategies that could extend leadership from metastatic into early disease. In allergic disease, the planned acquisition of a next‑generation anti‑IgE alongside BTK inhibition suggests a bid to compress time to symptom control and broaden disease control across CSU, inducible urticarias, and potentially food allergy—an arena where payers will demand head‑to‑head and durability data. And in neuromuscular disorders, Avidity brings late‑stage xRNA assets that fit a broader move toward muscle‑targeted precision therapeutics.
The next catalysts arrive quickly: regulatory outcomes for ianalumab and Fabhalta, the start of remibrutinib’s Phase 3 program in food allergy, and pivotal neuromuscular readouts in the back half. The strategic test is whether Novartis can convert scientific breadth into access at speed, particularly in the EU, while scaling manufacturing and evidence generation for radioligands and xRNA. If it succeeds, does this become the blueprint for outgrowing LOE in a pricing‑constrained world—or will regional regulatory asymmetry and payer scrutiny force another turn of the commercial model?
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
